Rezum I Pilot Study for Benign Prostatic Hyperplasia

NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943070

Acronym

Rezum Pilot

Enrollment

Registered

2016-10-24

Start date

2012-03-31

Completion date

2018-12-31

Last updated

2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia, Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Prostatic Hypertrophy, Benign, Rezum

Keywords

Rezum, Water Vapor Ablation

Brief summary

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Detailed description

Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.

Interventions

DEVICERezum System

The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male subjects \> 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention. 2. IPSS score of ≥ 15. 3. Qmax: Peak flow rate ≤ 15 ml/sec. 4. Post-void residual (PVR) \< 300 ml. 5. Prostate transverse diameter \> 30 mm. 6. Prostate volume between 20 to 120 gm. 7. Voided volume ≥ 125 mL 8. Subject able to complete the study protocol in the opinion of the investigator. 9. Life expectancy of at least one year.

Exclusion criteria

1. History of any illness or surgery that may confound the results of the study or have risk to subject. 2. Presence of a penile implant. 3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH. 4. Currently enrolled or has been enrolled in another trial in the past 30 days. 5. Confirmed or suspected malignancy of prostate or bladder 6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease. 7. Previous pelvic irradiation or radical pelvic surgery. 8. Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catherization specimen) 9. Neurogenic bladder or sphincter abnormalities. 10. Urethral strictures, bladder neck contracture or muscle spasms. 11. Bleeding disorder or is currently on coumadin. (Note that use of anti-platelet medication is not an

Design outcomes

Primary

Measure	Time frame	Description
International Prostate Symptom Score (IPSS) Change From Baseline	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Major Complications	3 months	Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: 1. Severe Urinary Retention (Retention ≥ 24 hours) 2. Fistula between rectum and urethra 3. Perforation of the rectum or GI tract 4. New incidences of retrograde ejaculation

Secondary

Measure	Time frame	Description
Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months, 6 months, 1 year, annually to 5 years
Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. Average results are based on age and sex. Typical uroflow rates ranges from 10 ml to 21 ml per second. An increase in mL/sec corresponds to improved urinary function.
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥ 30% improvement from baseline at each follow-up interval.
Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥3 mL/sec improvement from baseline at each follow-up interval.
Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	Change in post void residual (PVR) urine volume in ml. Post void residual volume was measured by either ultrasound to measure the volume left in the bladder after urination, or by inserting a urinary catheter into the bladder after urination to drain and measure residual urine. Either measurement tool was allowed but the same measurement was to be used pre and post treatment.
Change in Sexual Function - Erectile Function	1 month, 3 months, 6 months, 1 year, annually to 5 years	Change from baseline in sexual function was measured by the International Index of Erectile Function (IIEF) (Scoring on the IIEF ranges from 1 to 30. An increase in score indicates improvement from baseline)
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	1 month, 3 months, 6 months, 1 year, then annually to 5 years	Quality of Life was measured using EQ-5D-3L questionnaire and collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. The EQ-5D-3L includes a visual analog scale (VAS) which is a vertical scale with numbers ranging from 0 to 100. Subjects were asked to draw a line to the place on the scale that best represented how good or bad his health was on that day. The worst state a subject can imagine is marked zero, and the best state the subject can imagine is marked 100. Mean change in VAS score from baseline is reported. An increase in score is considered a better outcome.
Change in Sexual Function - Retrograde Ejaculation	1 Week post procedure, 1 Month post procedure, 3 Months post procedure	Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)
International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.
International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score. Results report change in IPSS by follow up interval for subjects treated in both lateral lobes and median lobe vs. subjects treated in lateral lobes alone.
Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	The proportion of study subjects who were responders were evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS.
Procedural Pain Score	Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure	Pain scores were obtained for all subjects using the Iowa Pain Thermometer. Maximum intraprocedural pain scores were analyzed, together with the pain scores reported at follow-up intervals through 3 months. The treatment pain scores were reported by subjects post-procedure and was based on their recollections. Scale is 0-12 with higher scores corresponding to higher pain reported.
Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years	Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit. One question in the IPSS asked subjects to rate their quality of life due to urinary symptoms on a scale of 0 = Delighted to 6 = Terrible. A reduction in score from baseline equates to improved outcome.
Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years	Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits. BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.
Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	1 month, 3 months, 6 months, 1 year, then annually to 5 years	Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. EQ-5D-3L index ranges from -0.109 to 1.000, with 1.000 corresponding to the best health state and -0.109 corresponding to the worst health. Mean change in overall score from baseline is reported.
Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 month, 3 months, 6 months, 1 year, then annually to 5 years	Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. Each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Presented below are the scoring counts for each of the dimensions for baseline and follow up interval.
Subject Satisfaction - Satisfied With Overall Procedure	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years	Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. These will be measured as: • Proportion of subjects that are satisfied with the procedure overall Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different n by question within the same follow-up time point.
Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years	Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects that would recommend this treatment to friends and families Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different n by question within the same follow-up time point.
Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years	Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different n by question within the same follow-up time point.
Procedural Parameters - Procedure Time	Day of Procedure	Procedure time: Time from delivery device insertion to final delivery device withdrawal
Procedural Parameters - Treatment Time	Day of Procedure	Treatment time: time from first vapor delivery to last vapor delivery
International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval and grouped by Baseline IPSS. Improvement in symptoms is shown by a reduction in score.
Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years	The proportion of study subjects who were responders were evaluated. For this measure a responder is defined as a subject with ≥ 50% improvement in BPH symptoms from baseline as measured by the IPSS.

Countries

Czechia, Dominican Republic, Sweden

Participant flow

Recruitment details

This prospective, international, multicenter, non-randomized study recruited subjects who met inclusion/exclusion criteria and consented to participate. Subjects on BPH medication underwent a washout period prior to treatment. Subjects who successfully completed the washout period and still met the inclusion/exclusion criteria were enrolled in the study. Subjects were considered officially enrolled only if treatment with the NxThera Rezūm System was attempted.

Participants by arm

Arm	Count
Rezum Treatment Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.	50
Total	50

Arm

Count

Rezum Treatment

Subjects received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia. Rezum System: The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Death	2
Overall Study	Lost to Follow-up	4
Overall Study	Physician Decision	1
Overall Study	Retreatment or TURP	13
Overall Study	Subjects exited after their 48 month visit per the Sponsor's decision to close the study.	18
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Rezum Treatment
Age, Continuous	65.5 years STANDARD_DEVIATION 7.1
Race/Ethnicity, Customized Ethnicity Black or African Origin	2 Participants
Race/Ethnicity, Customized Ethnicity Caucasian	45 Participants
Race/Ethnicity, Customized Ethnicity Hispanic or Latino	3 Participants
Region of Enrollment Czechia	18 participants
Region of Enrollment Dominican Republic	5 participants
Region of Enrollment Sweden	27 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	50 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 50
other Total, other adverse events	38 / 50
serious Total, serious adverse events	8 / 50

Outcome results

Primary

International Prostate Symptom Score (IPSS) Change From Baseline

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change (improvement) in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Mean change (improvement) in score was calculated for the number of subjects providing data at each follow-up visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 6 Months	-12.6 score on a scale	Standard Deviation 7.9
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 12 Months	-12.2 score on a scale	Standard Deviation 7.7
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 24 Months	-11.7 score on a scale	Standard Deviation 8.4
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 1 Week	-0.4 score on a scale	Standard Deviation 7.8
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 1 Month	-5.0 score on a scale	Standard Deviation 8.3
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 3 Months	-13.1 score on a scale	Standard Deviation 7.2
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 36 Months	-9.4 score on a scale	Standard Deviation 9
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 48 Months	-9.6 score on a scale	Standard Deviation 7.5
Rezum Treatment	International Prostate Symptom Score (IPSS) Change From Baseline	IPSS Change at 60 Months	-8.4 score on a scale	Standard Deviation 6.7

Primary

Major Complications

Safety assessed by the frequency of systemic and local serious device related complications and the occurrence of unanticipated device-related adverse effects during treatment and at follow-up, up to 30 days. Due to the nature of the device, any device-related AEs are expected to present themselves during the immediate peri-procedure period (30 days post procedure). The device related complications that will be compared for this safety endpoint are: 1. Severe Urinary Retention (Retention ≥ 24 hours) 2. Fistula between rectum and urethra 3. Perforation of the rectum or GI tract 4. New incidences of retrograde ejaculation

Time frame: 3 months

Population: Incidence of device-related complications pre-specified under this safety endpoint assessed through 3 months post-implant.

Arm	Measure	Group	Value (NUMBER)
Rezum Treatment	Major Complications	Severe urinary retention (retention >=24 hours	1 clinically relevant complications
Rezum Treatment	Major Complications	Fistula between rectum and urethra	0 clinically relevant complications
Rezum Treatment	Major Complications	Perforation of the Rectum or GI Tract	0 clinically relevant complications
Rezum Treatment	Major Complications	New incidences of retrograde ejaculation	0 clinically relevant complications

Secondary

Change in Sexual Function - Erectile Function

Change from baseline in sexual function was measured by the International Index of Erectile Function (IIEF) (Scoring on the IIEF ranges from 1 to 30. An increase in score indicates improvement from baseline)

Time frame: 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Mean change in total score was calculated for subjects providing data at each follow-up visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 48 Months	2.7 score on a scale	Standard Deviation 27.4
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 60 Months	12.5 score on a scale	Standard Deviation 24.1
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 1 Month	-4.2 score on a scale	Standard Deviation 20.7
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 3 Months	3.3 score on a scale	Standard Deviation 20
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 6 Months	6.3 score on a scale	Standard Deviation 17.6
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 12 Months	5.8 score on a scale	Standard Deviation 16.4
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 24 Months	8.2 score on a scale	Standard Deviation 14.8
Rezum Treatment	Change in Sexual Function - Erectile Function	IEFF change from baseline at 36 Months	10.7 score on a scale	Standard Deviation 16.9

Secondary

Change in Sexual Function - Retrograde Ejaculation

Rate of Retrograde Ejaculation (when no fluid exits the penis during orgasm (e.g., dry orgasm)

Time frame: 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Change in Sexual Function - Retrograde Ejaculation	Incidence of retrograde ejaculation at 1 Week	0 Participants
Rezum Treatment	Change in Sexual Function - Retrograde Ejaculation	Incidence of retrograde ejaculation at 1 Month	0 Participants
Rezum Treatment	Change in Sexual Function - Retrograde Ejaculation	Incidence of retrograde ejaculation at 3 Months	0 Participants

Secondary

International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval and grouped by Baseline IPSS. Improvement in symptoms is shown by a reduction in score.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 48 Months	-7.2 score on a scale	Standard Deviation 5.2
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 12 Months	-8.2 score on a scale	Standard Deviation 5
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 24 Months	-7.9 score on a scale	Standard Deviation 5.2
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 36 Months	-6.9 score on a scale	Standard Deviation 5.2
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 1 Week	1.8 score on a scale	Standard Deviation 4.9
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 3 Months	-9.7 score on a scale	Standard Deviation 5.4
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 60 Months	-7.7 score on a scale	Standard Deviation 4.7
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 6 Months	-9.2 score on a scale	Standard Deviation 5.8
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 1 Month	-3.3 score on a scale	Standard Deviation 7
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 24 Months	-12.9 score on a scale	Standard Deviation 8.9
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 1 Week	-2.9 score on a scale	Standard Deviation 9.1
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 1 Month	-5.4 score on a scale	Standard Deviation 8.7
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 6 Months	-14.1 score on a scale	Standard Deviation 7.7
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 12 Months	-14.6 score on a scale	Standard Deviation 7.6
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 48 Months	-9.8 score on a scale	Standard Deviation 8.3
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 60 Months	-3.5 score on a scale	Standard Deviation 7.8
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 3 Months	-13.9 score on a scale	Standard Deviation 7.1
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 36 Months	-9.0 score on a scale	Standard Deviation 10.9
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 48 Months	-17.7 score on a scale	Standard Deviation 8
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 3 Months	-21.4 score on a scale	Standard Deviation 5.5
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 1 Week	-0.1 score on a scale	Standard Deviation 10.2
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 60 Months	-14.5 score on a scale	Standard Deviation 6.4
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 1 Month	-9.0 score on a scale	Standard Deviation 10.6
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 24 Months	-20.6 score on a scale	Standard Deviation 9.2
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 12 Months	-19.2 score on a scale	Standard Deviation 9.2
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 6 Months	-19.7 score on a scale	Standard Deviation 8.9
Subjects With Baseline IPSS 26-35	International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS	IPSS Change at 36 Months	-20.7 score on a scale	Standard Deviation 4

Secondary

International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score. Results report change in IPSS by follow up interval for subjects treated in both lateral lobes and median lobe vs. subjects treated in lateral lobes alone.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 1 Week	0.4 score on a scale	Standard Deviation 7.6
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 1 Month	-4.1 score on a scale	Standard Deviation 7
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 3 Months	-11.9 score on a scale	Standard Deviation 6.7
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 12 Months	-11.9 score on a scale	Standard Deviation 7.5
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 24 Months	11.7 score on a scale	Standard Deviation 7.7
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 36 Months	-9.4 score on a scale	Standard Deviation 8.9
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 48 Months	-10.5 score on a scale	Standard Deviation 7.4
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 60 Months	-8.2 score on a scale	Standard Deviation 7.3
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 6 Months	-12.2 score on a scale	Standard Deviation 7.5
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 60 Months	-10.0 score on a scale	Standard Deviation 0
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 1 Week	-2.5 score on a scale	Standard Deviation 8.2
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 24 Months	-11.8 score on a scale	Standard Deviation 10.9
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 1 Month	-7.4 score on a scale	Standard Deviation 11.2
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 48 Months	-5.6 score on a scale	Standard Deviation 7.5
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 3 Months	-17.0 score on a scale	Standard Deviation 7.8
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 6 Months	-14.3 score on a scale	Standard Deviation 9.2
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 36 Months	-9.2 score on a scale	Standard Deviation 10.2
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe	IPSS Change at 12 Months	-13.1 score on a scale	Standard Deviation 8.7

Secondary

International Prostate Symptom Score (IPSS) Assessment by Prostate Volume

International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Mean change in IPSS scores reported at each follow-up interval. Improvement in symptoms is shown by a reduction in score.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects providing data at each follow-up visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 24 Months	-10.2 score on a scale	Standard Deviation 8.4
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 1 Month	-3.4 score on a scale	Standard Deviation 8
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 48 Months	-9.6 score on a scale	Standard Deviation 8.4
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 3 Months	-12.0 score on a scale	Standard Deviation 6.6
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 36 Months	-9.2 score on a scale	Standard Deviation 9.3
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 6 Months	-11.8 score on a scale	Standard Deviation 7.1
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 60 Months	-6.0 score on a scale	Standard Deviation 5.6
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 12 Months	-11.6 score on a scale	Standard Deviation 7.7
Rezum Treatment	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 1 Week	0.3 score on a scale	Standard Deviation 7.2
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 12 Months	-13.7 score on a scale	Standard Deviation 8
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 36 Months	10.0 score on a scale	Standard Deviation 8.8
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 48 Months	-9.5 score on a scale	Standard Deviation 4
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 60 Months	-14.5 score on a scale	Standard Deviation 6.4
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 1 Week	-2.4 score on a scale	Standard Deviation 9.3
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 1 Month	-9.4 score on a scale	Standard Deviation 7.8
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 3 Months	-15.9 score on a scale	Standard Deviation 8.3
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 6 Months	-14.9 score on a scale	Standard Deviation 9.7
Rezum Treatment - Smaller Prostates (<35g)	International Prostate Symptom Score (IPSS) Assessment by Prostate Volume	IPSS Change at 24 Months	-16.1 score on a scale	Standard Deviation 7.4

Secondary

Procedural Pain Score

Pain scores were obtained for all subjects using the Iowa Pain Thermometer. Maximum intraprocedural pain scores were analyzed, together with the pain scores reported at follow-up intervals through 3 months. The treatment pain scores were reported by subjects post-procedure and was based on their recollections. Scale is 0-12 with higher scores corresponding to higher pain reported.

Time frame: Day of treatment, 1 Day post procedure, 1 Week post procedure, 1 Month post procedure, 3 Months post procedure

Population: Subjects with data at the scheduled visits are included in the data summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Procedural Pain Score	Pain Score on day of Treatment	4.0 score on a scale	Standard Deviation 3.3
Rezum Treatment	Procedural Pain Score	Pain Score 1 Day Post-Treatment	1.9 score on a scale	Standard Deviation 2.3
Rezum Treatment	Procedural Pain Score	Pain Score 1 Week Post-Treatment	1.9 score on a scale	Standard Deviation 2.6
Rezum Treatment	Procedural Pain Score	Pain Score 1 Month Post-Treatment	1.2 score on a scale	Standard Deviation 2.1
Rezum Treatment	Procedural Pain Score	Pain Score 3 Months Post-Treatment	0.5 score on a scale	Standard Deviation 1.6

Secondary

Procedural Parameters - Procedure Time

Procedure time: Time from delivery device insertion to final delivery device withdrawal

Time frame: Day of Procedure

Population: Subjects with procedure data are included in the summarization.

Arm	Measure	Value (MEAN)	Dispersion
Rezum Treatment	Procedural Parameters - Procedure Time	6.7 minutes	Standard Deviation 5.8

Secondary

Procedural Parameters - Treatment Time

Treatment time: time from first vapor delivery to last vapor delivery

Time frame: Day of Procedure

Population: Subjects with procedure data are included in the summarization.

Arm	Measure	Value (MEAN)	Dispersion
Rezum Treatment	Procedural Parameters - Treatment Time	4.5 minutes	Standard Deviation 4.9

Secondary

Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement

The proportion of study subjects who were responders were evaluated. A responder is defined as a subject with ≥ 30% improvement in BPH symptoms from baseline as measured by the IPSS.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and at the follow-up visit are included in the data summarization.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 1 Week	12 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 1 Month	20 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 3 Months	39 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 6 Months	40 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 12 Months	36 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 24 Months	28 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 36 Months	19 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 48 Months	18 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with>=30% Improvement at 60 Months	4 Participants

Secondary

Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement

The proportion of study subjects who were responders were evaluated. For this measure a responder is defined as a subject with ≥ 50% improvement in BPH symptoms from baseline as measured by the IPSS.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visits are included in the data summarization.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 6 Months	35 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 12 Months	30 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Week	3 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 1 Month	14 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 3 Months	35 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 24 Months	20 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 36 Months	15 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 48 Months	13 Participants
Rezum Treatment	Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement	Proportion of Responders with a ≥ 50% IPSS Improvement at 60 Months	2 Participants

Secondary

Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS

Analysis will be provided for proportion of subjects with improvement ≥ 8 points from baseline at 1 week, 1 month, and 3 months, 6 months, 1 year, annually to 5 years

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 36 Months	17 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 48 Months	16 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Week	9 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 1 Month	18 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 3 Months	37 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 6 Months	37 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 12 Months	33 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 24 Months	24 Participants
Rezum Treatment	Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS	Proportion of Responders With Improvement ≥ 8 Points in IPSS at 60 Months	4 Participants

Secondary

Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)

Change in Quality of Life will be measured with the Benign Prostatic Hyperplasia Impact Index (BPHII). Data were collected at specified follow up visits. BPHII scores range from 0 (no/mild symptoms) to 35 (severe symptoms). A reduction in score from baseline equates to an improvement in symptoms.

Time frame: Baseline to 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 1 Month	-1.0 score on a scale	Standard Deviation 3.7
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 3 Months	-4.4 score on a scale	Standard Deviation 2.9
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 6 Months	-4.5 score on a scale	Standard Deviation 3.1
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 12 Months	-4.3 score on a scale	Standard Deviation 2.8
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 24 Months	-4.4 score on a scale	Standard Deviation 3.2
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 36 Months	-3.5 score on a scale	Standard Deviation 4
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 48 Months	-4.0 score on a scale	Standard Deviation 3.5
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)	Change from Baseline in BPHII Score at 60 Months	-2.1 score on a scale	Standard Deviation 4.2

Secondary

Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L

Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. EQ-5D-3L index ranges from -0.109 to 1.000, with 1.000 corresponding to the best health state and -0.109 corresponding to the worst health. Mean change in overall score from baseline is reported.

Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 1 Month	-0.0 score on a scale	Standard Deviation 0.2
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 12 Month	0.0 score on a scale	Standard Deviation 0.1
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 24 Month	0.0 score on a scale	Standard Deviation 0.1
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 36 Month	0.0 score on a scale	Standard Deviation 0.1
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 48 Month	-0.0 score on a scale	Standard Deviation 0.2
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 60 Month	-0.1 score on a scale	Standard Deviation 0.1
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 3 Month	0.0 score on a scale	Standard Deviation 0.2
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L	Change from Baseline in EQ-5D-3L Overall Score at 6 Month	0.1 score on a scale	Standard Deviation 0.1

Secondary

Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)

Quality of Life was measured using EQ-5D-3L questionnaire and collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. The EQ-5D-3L includes a visual analog scale (VAS) which is a vertical scale with numbers ranging from 0 to 100. Subjects were asked to draw a line to the place on the scale that best represented how good or bad his health was on that day. The worst state a subject can imagine is marked zero, and the best state the subject can imagine is marked 100. Mean change in VAS score from baseline is reported. An increase in score is considered a better outcome.

Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 3 Month	8.3 score on a scale	Standard Deviation 18.3
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 6 Month	9.1 score on a scale	Standard Deviation 14.5
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 12 Month	7.4 score on a scale	Standard Deviation 19.7
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 24 Month	5.8 score on a scale	Standard Deviation 18.3
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 1 Month	2.8 score on a scale	Standard Deviation 18
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 36 Month	9.2 score on a scale	Standard Deviation 20.9
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	-0.1Change from Baseline in EQ-5D-3L VAS Score at 48 Month	6.5 score on a scale	Standard Deviation 17.9
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)	Change from Baseline in EQ-5D-3L VAS Score at 60 Month	-0.1 score on a scale	Standard Deviation 11.9

Secondary

Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)

Change in Quality of Life was measured using a QoL question in the IPSS. QoL data were collected at each follow up visit. One question in the IPSS asked subjects to rate their quality of life due to urinary symptoms on a scale of 0 = Delighted to 6 = Terrible. A reduction in score from baseline equates to improved outcome.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 1 Week	-0.3 score on a scale	Standard Deviation 1.4
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 1 Month	-1.1 score on a scale	Standard Deviation 1.8
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 3 Months	-2.7 score on a scale	Standard Deviation 1.6
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 6 Months	-2.7 score on a scale	Standard Deviation 1.7
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 12 Months	-2.7 score on a scale	Standard Deviation 1.5
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change in IPSS QoL Change from Baseline in IPSS QoL Score at 24 Months	-2.6 score on a scale	Standard Deviation 1.7
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 36 Months	-2.4 score on a scale	Standard Deviation 2.1
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 48 Months	-2.5 score on a scale	Standard Deviation 1.6
Rezum Treatment	Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)	Change from Baseline in IPSS QoL Score at 60 Months	-1.6 score on a scale	Standard Deviation 1.8

Secondary

Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L

Quality of Life was measured using EQ-5D-3L questionnaire. QoL data were collected at each follow up visit. The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all subjects to assess the effect of the treatment on the subjects' quality of life. Each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Presented below are the scoring counts for each of the dimensions for baseline and follow up interval.

Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Anxiety Dimension Score	Level 2 (Some Problems)	8 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Anxiety Dimension Score	Level 1 (No Problems)	22 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Anxiety Dimension Score	Level 2 (Some Problems)	5 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Anxiety Dimension Score	Level 1 (No Problems)	19 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Anxiety Dimension Score	Level 2 (Some Problems)	7 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Anxiety Dimension Score	Level 1 (No Problems)	5 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Anxiety Dimension Score	Level 2 (Some Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Mobility Dimension Score	Level 1 (No Problems)	43 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Mobility Dimension Score	Level 2 (Some Problems)	7 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Mobility Dimension Score	Level 1 (No Problems)	43 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Mobility Dimension Score	Level 2 (Some Problems)	6 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Mobility Dimension Score	Level 2 (Some Problems)	5 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Mobility Dimension Score	Level 1 (No Problems)	40 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Mobility Dimension Score	Level 2 (Some Problems)	6 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Mobility Dimension Score	Level 1 (No Problems)	37 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Mobility Dimension Score	Level 2 (Some Problems)	8 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Mobility Dimension Score	Level 1 (No Problems)	27 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Mobility Dimension Score	Level 2 (Some Problems)	7 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Mobility Dimension Score	Level 1 (No Problems)	17 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Mobility Dimension Score	Level 1 (No Problems)	15 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Mobility Dimension Score	Level 2 (Some Problems)	10 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Mobility Dimension Score	Level 1 (No Problems)	3 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Pain Dimension Score	Level 1 (No Problems)	22 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Pain Dimension Score	Level 2 (Some Problems)	25 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Pain Dimension Score	Level 2 (Some Problems)	20 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Pain Dimension Score	Level 3 (Extreme Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Pain Dimension Score	Level 1 (No Problems)	32 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Pain Dimension Score	Level 1 (No Problems)	30 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Pain Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Pain Dimension Score	Level 1 (No Problems)	28 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Pain Dimension Score	Level 2 (Some Problems)	16 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Pain Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Pain Dimension Score	Level 1 (No Problems)	20 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Pain Dimension Score	Level 2 (Some Problems)	12 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Pain Dimension Score	Level 1 (No Problems)	17 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Pain Dimension Score	Level 2 (Some Problems)	9 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Pain Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Pain Dimension Score	Level 1 (No Problems)	12 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Pain Dimension Score	Level 2 (Some Problems)	12 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Pain Dimension Score	Level 3 (Extreme Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Pain Dimension Score	Level 1 (No Problems)	4 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Pain Dimension Score	Level 2 (Some Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Pain Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Self-care Dimension Score	Level 1 (No Problems)	50 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Self-care Dimension Score	Level 2 (Some Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Self-care Dimension Score	Level 1 (No Problems)	48 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Self-care Dimension Score	Level 2 (Some Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Self-care Dimension Score	Level 1 (No Problems)	47 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Self-care Dimension Score	Level 2 (Some Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Self-care Dimension Score	Level 1 (No Problems)	46 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Self-care Dimension Score	Level 2 (Some Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Self-care Dimension Score	Level 2 (Some Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Self-care Dimension Score	Level 1 (No Problems)	33 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Self-care Dimension Score	Level 2 (Some Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Self-care Dimension Score	Level 1 (No Problems)	26 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Self-care Dimension Score	Level 2 (Some Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Self-care Dimension Score	Level 1 (No Problems)	24 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Self-care Dimension Score	Level 2 (Some Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Self-care Dimension Score	Level 1 (No Problems)	6 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Usual Activity Dimension Score	Level 2 (Some Problems)	3 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	7 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Usual Activity Dimension Score	Level 1 (No Problems)	46 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	4 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Usual Activity Dimension Score	Level 1 (No Problems)	31 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Usual Activity Dimension Score	Level 1 (No Problems)	25 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Usual Activity Dimension Score	Level 1 (No Problems)	20 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	4 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	48 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Usual Activity Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Mobility Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Mobility Dimension Score	Level 1 (No Problems)	43 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Mobility Dimension Score	Level 2 (Some Problems)	10 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Mobility Dimension Score	Level 2 (Some Problems)	4 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Pain Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Pain Dimension Score	Level 1 (No Problems)	24 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Pain Dimension Score	Level 2 (Some Problems)	15 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Pain Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Pain Dimension Score	Level 2 (Some Problems)	16 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Pain Dimension Score	Level 3 (Extreme Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Self-care Dimension Score	Level 1 (No Problems)	45 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Self-care Dimension Score	Level 2 (Some Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Self-care Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Usual Activity Dimension Score	Level 1 (No Problems)	47 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Usual Activity Dimension Score	Level 1 (No Problems)	40 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Usual Activity Dimension Score	Level 1 (No Problems)	45 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	3 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Usual Activity Dimension Score	Level 1 (No Problems)	41 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	3 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	36 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Usual Activity Dimension Score	Level 1 (No Problems)	6 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	60 Month_Usual Activity Dimension Score	Level 2 (Some Problems)	1 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Anxiety Dimension Score	Level 1 (No Problems)	32 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Anxiety Dimension Score	Level 2 (Some Problems)	16 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	Baseline_Anxiety Dimension Score	Level 3 (Extreme Problems)	2 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Anxiety Dimension Score	Level 1 (No Problems)	39 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	1 Month_Anxiety Dimension Score	Level 2 (Some Problems)	8 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Anxiety Dimension Score	Level 1 (No Problems)	41 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Anxiety Dimension Score	Level 2 (Some Problems)	6 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	3 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Anxiety Dimension Score	Level 1 (No Problems)	40 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Anxiety Dimension Score	Level 2 (Some Problems)	6 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	6 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Anxiety Dimension Score	Level 1 (No Problems)	35 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Anxiety Dimension Score	Level 2 (Some Problems)	10 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	12 Month_Anxiety Dimension Score	Level 3 (Extreme Problems)	0 Participants
Rezum Treatment	Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L	24 Month_Anxiety Dimension Score	Level 1 (No Problems)	26 Participants

Secondary

Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects that would recommend this treatment to friends and families Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different n by question within the same follow-up time point.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 6 Months	Definitely Will	29 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Week	Definitely Will	26 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Week	Probably Will	14 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Week	Not Sure	7 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Week	Probably Will Not	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Week	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Month	Definitely Will	24 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Month	Probably Will	16 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Month	Not Sure	6 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Month	Probably Will Not	2 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 1 Month	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 3 Months	Definitely Will	33 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 3 Months	Probably Will	10 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 3 Months	Not Sure	4 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 3 Months	Probably Will Not	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 3 Months	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 6 Months	Probably Will	12 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 6 Months	Not Sure	5 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 6 Months	Probably Will Not	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 6 Months	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 12 Months	Definitely Will	30 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 12 Months	Probably Will	12 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 12 Months	Not Sure	3 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 12 Months	Probably Will Not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 12 Months	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 24 Months	Definitely Will	18 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 24 Months	Probably Will	8 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 24 Months	Not Sure	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 24 Months	Probably Will Not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 24 Months	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 36 Months	Definitely Will	17 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 36 Months	Probably Will	5 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 36 Months	Not Sure	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 36 Months	Probably Will Not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 36 Months	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 48 Months	Definitely Will	17 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 48 Months	Probably Will	8 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 48 Months	Not Sure	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 48 Months	Probably Will Not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 48 Months	Definitely Will not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 60 Months	Definitely Will	4 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 60 Months	Probably Will	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 60 Months	Not Sure	2 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 60 Months	Probably Will Not	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family	Proportion of subjects who would recommend procedure to friends/family at 60 Months	Definitely Will not	0 Participants

Secondary

Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. Outcome measured as: • Proportion of subjects who would undergo the same treatment if their symptoms were to recur after 5 years Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different n by question within the same follow-up time point.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	23 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	17 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	6 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Week willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	17 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	21 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	8 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	2 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 1 Month willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	27 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	15 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	5 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 3 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	25 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	13 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	8 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 6 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	29 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	10 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 12 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	5 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	12 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	12 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	2 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 24 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	1 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	10 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	8 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	2 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	3 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 36 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Likely	12 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	8 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	5 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 48 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Very Unlikely	0 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Likely	3 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Not Sure	3 Participants
Rezum Treatment	Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years	Subjects at 60 Months willing to undergo re-treatment in 5 years if symptoms were to recur	Unlikely	0 Participants

Secondary

Subject Satisfaction - Satisfied With Overall Procedure

Subject satisfaction assessed using a study specific questionnaire to evaluate the subject's overall satisfaction of the procedure at 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years. These will be measured as: • Proportion of subjects that are satisfied with the procedure overall Note: Subject Satisfaction Questionnaire is specific to the NxThera Rezūm treatment and 3 of the 7 questions were used to evaluate the subjects' overall satisfaction with the procedure. Within the questionnaire, subjects sometimes did not answer all of the questions, which resulted in a different n by question within the same follow-up time point.

Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, and annually to 5 years

Population: Subjects with data at baseline and follow-up visit are included in the summarization.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Week	Very Satisfied	16 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Week	Satisfied	23 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Week	Neither Satisfied or Dissatisfied (Neutral)	6 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Week	Dissatisfied	2 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Week	Very Dissatisfied	1 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Month	Very Satisfied	18 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Month	Satisfied	19 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 3 Months	Very Satisfied	21 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 12 Months	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 24 Months	Satisfied	12 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 24 Months	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 48 Months	Satisfied	11 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 60 Months	Very Satisfied	1 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 60 Months	Satisfied	4 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 60 Months	Neither Satisfied or Dissatisfied (Neutral)	2 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Month	Neither Satisfied or Dissatisfied (Neutral)	8 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Month	Dissatisfied	2 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 1 Month	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 3 Months	Satisfied	22 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 3 Months	Neither Satisfied or Dissatisfied (Neutral)	3 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 3 Months	Dissatisfied	1 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 3 Months	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 6 Months	Very Satisfied	18 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 6 Months	Satisfied	20 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 6 Months	Neither Satisfied or Dissatisfied (Neutral)	7 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 6 Months	Dissatisfied	2 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 6 Months	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 12 Months	Very Satisfied	19 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 12 Months	Satisfied	19 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 12 Months	Neither Satisfied or Dissatisfied (Neutral)	6 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 12 Months	Dissatisfied	1 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 24 Months	Very Satisfied	12 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 24 Months	Neither Satisfied or Dissatisfied (Neutral)	3 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 24 Months	Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 36 Months	Very Satisfied	11 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 36 Months	Satisfied	8 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 36 Months	Neither Satisfied or Dissatisfied (Neutral)	4 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 36 Months	Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 36 Months	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 48 Months	Very Satisfied	10 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 48 Months	Neither Satisfied or Dissatisfied (Neutral)	3 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 48 Months	Dissatisfied	2 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 48 Months	Very Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 60 Months	Dissatisfied	0 Participants
Rezum Treatment	Subject Satisfaction - Satisfied With Overall Procedure	Proportion of subjects satisfied with the procedure at 60 Months	Very Dissatisfied	0 Participants

Secondary

Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. Average results are based on age and sex. Typical uroflow rates ranges from 10 ml to 21 ml per second. An increase in mL/sec corresponds to improved urinary function.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Mean change in urinary flow rate was calculated for subjects with data at baseline and follow-up visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 3 Months	5.5 mL/sec	Standard Deviation 6.6
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 1 Week	-0.2 mL/sec	Standard Deviation 4.3
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 1 Month	1.9 mL/sec	Standard Deviation 4.8
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 6 Months	5.2 mL/sec	Standard Deviation 5.7
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 12 Months	4.7 mL/sec	Standard Deviation 7
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 24 Months	4.1 mL/sec	Standard Deviation 6.7
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 36 Months	3.5 mL/sec	Standard Deviation 6.2
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 48 months	3.0 mL/sec	Standard Deviation 4.3
Rezum Treatment	Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)	Change from baseline in peak urinary flow rate (Qmax) at 60 Months	3.9 mL/sec	Standard Deviation 4.3

Secondary

Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval

Change in post void residual (PVR) urine volume in ml. Post void residual volume was measured by either ultrasound to measure the volume left in the bladder after urination, or by inserting a urinary catheter into the bladder after urination to drain and measure residual urine. Either measurement tool was allowed but the same measurement was to be used pre and post treatment.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects with data at baseline and follow-up visit.

Arm	Measure	Group	Value (MEAN)	Dispersion
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 3 Months	-30.5 ml	Standard Deviation 72.4
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 1 Week	48.8 ml	Standard Deviation 135.9
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 1 Month	-20.2 ml	Standard Deviation 94.7
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 6 Months	-27.1 ml	Standard Deviation 81.6
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 12 Months	-22.8 ml	Standard Deviation 83.7
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 24 Months	-11.8 ml	Standard Deviation 102.2
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 36 Months	11.9 ml	Standard Deviation 134.4
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 48 months	-14.3 ml	Standard Deviation 54.5
Rezum Treatment	Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval	Change from baseline in PVR at 60 Months	-12.6 ml	Standard Deviation 52.4

Secondary

Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥ 30% improvement from baseline at each follow-up interval.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects with data at baseline and follow-up visit.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 48 months	4 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 60 Months	4 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 1 Week	14 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 1 Month	21 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 3 Months	28 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 6 Months	32 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 12 Months	30 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 24 Months	20 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline	Qmax improvement of 30% or more over baseline at 36 Months	13 Participants

Secondary

Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec

Peak urinary flow rate (Qmax) is the maximum urinary flow rate. It is calculated as milliliters (ml) of urine passed per second. This measure reports the number of subjects who experienced a ≥3 mL/sec improvement from baseline at each follow-up interval.

Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Population: Measure calculated for subjects with data at baseline and follow-up visit.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Week	11 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 1 Month	19 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 3 Months	30 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 6 Months	30 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 12 Months	27 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 24 Months	18 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 36 Months	12 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 48 months	3 Participants
Rezum Treatment	Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec	Subjects with Qmax Improvement of ≥ 3 ml/sec at 60 Months	3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Rezum I Pilot Study for Benign Prostatic Hyperplasia

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

International Prostate Symptom Score (IPSS) Change From Baseline

Major Complications

Change in Sexual Function - Erectile Function

Change in Sexual Function - Retrograde Ejaculation

International Prostate Symptom Score (IPSS) Assessment Based on Baseline IPSS

International Prostate Symptom Score (IPSS) Assessment Based on Prostate Lobe Treated: Lateral Only vs. Lateral and Median Lobe

International Prostate Symptom Score (IPSS) Assessment by Prostate Volume

Procedural Pain Score

Procedural Parameters - Procedure Time

Procedural Parameters - Treatment Time

Proportion of Responders - Responders With a ≥ 30% International Prostate Symptom Score (IPSS) Improvement

Proportion of Responders - Responders With a ≥ 50% International Prostate Symptom Score (IPSS) Improvement

Proportion of Responders - Responders With Improvement ≥ 8 Points in IPSS

Quality of Life (QoL) - Change in QoL as Measured With the Benign Prostatic Hyperplasia Impact Index (BPHII)

Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L

Quality of Life (QoL) - Change in QoL as Measured With the EQ-5D-3L Visual Analog Scale (VAS)

Quality of Life (QoL) - Change in QoL as Measured With the International Prostate Symptom Score (IPSS)

Quality of Life (QoL) - QoL Dimensions as Measured With the EQ-5D-3L

Subject Satisfaction - Proportion of Subjects Who Would Recommend Procedure to Friends and Family

Subject Satisfaction - Proportion of Subjects Who Would Undergo Same Treatment if Symptoms Were to Recur After 5 Years

Subject Satisfaction - Satisfied With Overall Procedure

Uroflow Assessment - Change From Baseline in Peak Urinary Flow (Qmax)

Uroflow Assessment - Change in Post Void Residual (PVR) by Follow up Interval

Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 30% From Baseline

Uroflow Assessment - Proportion of Subjects With Qmax Improvement of ≥ 3 ml/Sec