Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Prostatic Hypertrophy, Benign, Rezum
Conditions
Keywords
Rezum
Brief summary
Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).
Detailed description
Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.
Interventions
DEVICERezum System
The Rezūm System is designed to treat 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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 Principal Investigator. 9. Subject must be willing to undergo the procedure without anesthesia.
Exclusion criteria
1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study. 2. Presence of a penile implant. 3. Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH. 4. Currently enrolled in another clinical trial. 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 catheterization specimen). 9. Neurogenic bladder or sphincter abnormalities. 10. Urethral strictures, bladder neck contracture or muscle spasms. 11. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion). 12. Subjects who are interested in maintaining fertility. 13. Use of concomitant (or recent) medications to include the following: 1. Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes). 2. Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment. 3. 5-alpha reductase inhibitor within the last 6 months 14. Subject is unable or unwilling to go through a washout period for the above medications prior to treatment. 15. Subject has chronic urinary retention. 16. Significant urge incontinence. 17. Poor detrusor muscle function. 18. Neurological disorders which might affect bladder or sphincter function. 19. Bladder stones. 20. Renal impairment. 21. In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure. 22. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements. 23. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study. 24. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum). 25. Biopsy of the prostate within 30 days prior to the Rezūm procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score | 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. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Requiring Catheterization Post Procedure | 1 day post procedure, 1 week post procedure, 1 month post procedure | All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded. |
| Post Procedure Catheterization Duration | 1 month post procedure | Measures the duration (days) of catheterization for subjects who required catheterization post procedure. Post-procedure catheterization was allowed if the Principal Investigator determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons. |
| Intra-procedural and Post-procedural Pain | Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure | Intra-procedural and post-procedural pain for each subject was assessed using the Wong Baker Pain Rating scale (0-10 with 0 indicating no pain and 10 indicating worst pain imaginable). Each subject selected the response on the pain scale that he felt best represented his pain level. Unless otherwise noted, the subjects were not given pain medications or anesthesia. All subjects were given an anti-anxiety medication plus a Non-Steroidal Anti-Inflammatory Drug (NSAID) pre-procedure. |
| Lesion Characteristics Via MRI (Changes in Prostate Volume) | 1 week, 1 month, 3 months, 6 months post-procedure | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in prostate volume was calculated. |
| Lesion Characteristics Via MRI (Changes in Transition Zone Volume) | 1 week, 1 month, 3 months, 6 months post-procedure | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in transition (TZ) zone volume was calculated |
| Lesion Characteristics Via MRI (Changes in Lesion Volume) | 1 week , 1 month, 3 months, 6 months post procedure | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in lesion volume was calculated. |
Countries
Dominican Republic
Participant flow
Recruitment details
This single arm, single center interventional 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 Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.
Rezum System: The Rezūm System is designed to treat 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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Retreatment | 3 |
Baseline characteristics
| Characteristic | Rezum Treatment |
|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 8.8 |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 14 Participants |
| Region of Enrollment Dominican Republic | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 15 |
| other Total, other adverse events | 14 / 15 |
| serious Total, serious adverse events | 3 / 15 |
Outcome results
Primary
Change in International Prostate Symptom Score
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. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure.
Time frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Population: Mean change in score was calculated for the number of subjects providing data at each follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS Change at 1 Week | -6.1 score on a scale | Standard Deviation 13.8 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS Change at 1 Month | -12.9 score on a scale | Standard Deviation 12.8 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 3 months | -14.6 score on a scale | Standard Deviation 9.1 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 6 months | -14.8 score on a scale | Standard Deviation 11 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 12 months | -13.6 score on a scale | Standard Deviation 7.5 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 24 months | -13.9 score on a scale | Standard Deviation 5.1 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 36 months | -7.6 score on a scale | Standard Deviation 6.4 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 48 months | -13.0 score on a scale | Standard Deviation 7.4 |
| Rezum Treatment | Change in International Prostate Symptom Score | IPSS change at 60 months | -7.6 score on a scale | Standard Deviation 6.3 |
Other Pre-specified
Intra-procedural and Post-procedural Pain
Intra-procedural and post-procedural pain for each subject was assessed using the Wong Baker Pain Rating scale (0-10 with 0 indicating no pain and 10 indicating worst pain imaginable). Each subject selected the response on the pain scale that he felt best represented his pain level. Unless otherwise noted, the subjects were not given pain medications or anesthesia. All subjects were given an anti-anxiety medication plus a Non-Steroidal Anti-Inflammatory Drug (NSAID) pre-procedure.
Time frame: Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure
Population: Pain score was not collected for 1 subject at each of the following visits: 1 day, 3 month, and 6 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rezum Treatment | Intra-procedural and Post-procedural Pain | average pain 3 months post-procedure | 0.0 score on a scale | Standard Deviation 0 |
| Rezum Treatment | Intra-procedural and Post-procedural Pain | average pain score post-procedure (day of procedure) | 3.5 score on a scale | Standard Deviation 2.7 |
| Rezum Treatment | Intra-procedural and Post-procedural Pain | average pain 1 day post-procedure | 0.1 score on a scale | Standard Deviation 0.3 |
| Rezum Treatment | Intra-procedural and Post-procedural Pain | average pain 1 week post-procedure | 0.2 score on a scale | Standard Deviation 0.6 |
| Rezum Treatment | Intra-procedural and Post-procedural Pain | average pain 1 month post-procedure | 0.5 score on a scale | Standard Deviation 2.1 |
| Rezum Treatment | Intra-procedural and Post-procedural Pain | average pain 6 months post-procedure | 0.0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Lesion Characteristics Via MRI (Changes in Lesion Volume)
Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in lesion volume was calculated.
Time frame: 1 week , 1 month, 3 months, 6 months post procedure
Population: One subject (each) did not have MRI available at the 3 month and 6 month follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Lesion Volume) | Mean percent change from 1 week to 1 month | -53.7 percentage of change in lesion volume | Standard Deviation 17.8 |
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Lesion Volume) | Mean percent change from 1 week to 3 months | -88.9 percentage of change in lesion volume | Standard Deviation 8.1 |
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Lesion Volume) | Mean percent change from 1 week to 6 months | -95.8 percentage of change in lesion volume | Standard Deviation 4.8 |
Other Pre-specified
Lesion Characteristics Via MRI (Changes in Prostate Volume)
Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in prostate volume was calculated.
Time frame: 1 week, 1 month, 3 months, 6 months post-procedure
Population: One subject (each) did not have MRI data available at the 3 month and 6 month visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Prostate Volume) | Mean percent change from 1 week to 1 month | -14.7 percentage of change in prostate volume | Standard Deviation 13.2 |
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Prostate Volume) | Mean percent change from 1 week to 3 months | -25.6 percentage of change in prostate volume | Standard Deviation 11.4 |
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Prostate Volume) | Mean percent change from 1 week to 6 months | -32.3 percentage of change in prostate volume | Standard Deviation 10.8 |
Other Pre-specified
Lesion Characteristics Via MRI (Changes in Transition Zone Volume)
Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in transition (TZ) zone volume was calculated
Time frame: 1 week, 1 month, 3 months, 6 months post-procedure
Population: One subject (each) did not have MRI available at the 3 month and 6 month visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Transition Zone Volume) | Mean percent change from 1 week to 1 month | -18.6 percentage of change in TZ volume | Standard Deviation 15 |
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Transition Zone Volume) | Mean percent change from 1 week to 3 months | -30.4 percentage of change in TZ volume | Standard Deviation 13.6 |
| Rezum Treatment | Lesion Characteristics Via MRI (Changes in Transition Zone Volume) | Mean percent change from 1 week to 6 months | -37.7 percentage of change in TZ volume | Standard Deviation 14.6 |
Other Pre-specified
Number of Subjects Requiring Catheterization Post Procedure
All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded.
Time frame: 1 day post procedure, 1 week post procedure, 1 month post procedure
Population: Number of subjects requiring post-procedure catheterization. Two (2) subjects were catheterized prior to the Rezūm study enrollment and treatment. The decision was made to move forward with treating both subjects. All subjects were observed for 24 hours in the clinic post-procedure. Post-procedure catheterization was allowed if determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rezum Treatment | Number of Subjects Requiring Catheterization Post Procedure | Subjects catheterized at 1 day post procedure | 9 participants |
| Rezum Treatment | Number of Subjects Requiring Catheterization Post Procedure | Subjects catheterized at 1 week post procedure | 8 participants |
| Rezum Treatment | Number of Subjects Requiring Catheterization Post Procedure | Subjects catheterized at 1 month post procedure | 3 participants |
Other Pre-specified
Post Procedure Catheterization Duration
Measures the duration (days) of catheterization for subjects who required catheterization post procedure. Post-procedure catheterization was allowed if the Principal Investigator determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons.
Time frame: 1 month post procedure
Population: Data provided for subjects who underwent the Rezūm ablation procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rezum Treatment | Post Procedure Catheterization Duration | Overall catheterization duration (days) per subject | 7.6 days | Standard Deviation 10.9 |
| Rezum Treatment | Post Procedure Catheterization Duration | Overall catheterization duration (days) per episode (13 episodes in 10 subjects) | 5.8 days | Standard Deviation 6.8 |