Treatment of Benign Prostatic Hyperplasia
Conditions
Brief summary
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure. The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.
Interventions
DEVICELumenis Pulse P120H and Xpeeda side firing fiber
Sponsors
Lumenis Be Ltd.
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject will be older than 18 years of age * Subject was diagnosed with enlarged prostate of ≥ 30 gr volume * Subject is a candidate for surgery treatment * Subject is willing and has signed the Informed Consent Form * AUA score ≥ 12 * Qmax \<15 mL/s
Exclusion criteria
* Need to perform concomitant procedure, other than prostate vaporization * PVR \> 300 mL * Current Urine retention and Pdet \<40 cm H20 * Documented or suspected prostate cancer and / or bladder cancer * Neurogenic bladder disorder / neurogenic voiding dysfunction * Urethral strictures * Previous prostatic, bladder neck, or urethral surgery * Known history of spinal cord injury * Urogenital trauma * Bladder neck stricture * Evidence of urinary tract infection * History of chronic prostatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation Time | Intraprocedural (procedure time is typically 1 to 3 hours) | Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency. |
| Ablation Rate | Baseline and 3-month follow-up visit | Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes |
| Efficiency of the Laser to Ablate the Prostate | Baseline and 3-month follow-up visit | Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J |
| Safety: Intraoperative Complications | Intraoperative (procedure time is typically 1 to 3 hours) | Number and type of intraoperative complications |
| Safety: Perioperative Complications | Post-procedure through 3 months | Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score Quality of Life | Baseline, 1-month and 3-month follow-up visits | The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). The Quality of Life question has a scale of 0-6, with 0=delighted and 6=terrible. |
| Qmax Uroflow | Baseline, 1-month and 3-month follow-up visits | The maximum urine flow rate (Qmax) is a measure of the quantity of urine excreted in a specified period of time, expressed in cubic centimeters/second (cc/sec). |
| Erectile Dysfunction | Baseline and 3-month follow-up visit | Sum score of International Index of Erectile Function (IIEF-5) questionnaire which measures erectile function, orgasmic function, sexual desire, and satisfaction. Each question is ranked 1-5 with a total sum score of 5 (severe erectile dysfunction) to 25 (normal function). |
| PSA (Prostate-specific Antigen) | Baseline and 3-month follow-up visit | Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels. |
| Americal Urological Association (AUA) Symptom Index | Baseline, 1-month and 3-month follow-up visits | The American Urological Association (AUA) Symptom Index assesses the severity of lower urinary tract symptoms in men, particularly related to benign prostatic hyperplasia. The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms related to benign prostatic hyperplasia (BPH). |
| PVR (Post-void Residual) | Baseline, 1-month and 3-month follow-up visits | Volume of urine remaining in the bladder after voiding, measured via ultrasound |
| Visibility During Procedure | Intraprocedural (procedure time is typically 1 to 3 hours) | Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure |
| Number of Fibers Used During Procedure | Intraprocedural (procedure time is typically 1 to 3 hours) | Number of fibers used during the BPH procedure |
| Catheterization Time | Postoperatively through study completion up to 3 months | Number of days catheter was in place post-ablation of the prostate |
| Hospital Stay Duration | Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months) | Number of days in hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ablation of the Prostate ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser
Lumenis Pulse P120H and Xpeeda side firing fiber | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Ablation of the Prostate | — |
|---|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 7.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 12 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Ablation Rate
Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes
Time frame: Baseline and 3-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablation of the Prostate | Ablation Rate | 0.4 mL/minutes | Standard Deviation 0.2 |
Primary
Ablation Time
Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.
Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablation of the Prostate | Ablation Time | 36.0 Minutes | Standard Deviation 19.3 |
Primary
Efficiency of the Laser to Ablate the Prostate
Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J
Time frame: Baseline and 3-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablation of the Prostate | Efficiency of the Laser to Ablate the Prostate | 9.4 mL/Joules | Standard Deviation 6.9 |
Primary
Safety: Intraoperative Complications
Number and type of intraoperative complications
Time frame: Intraoperative (procedure time is typically 1 to 3 hours)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ablation of the Prostate | Safety: Intraoperative Complications | Bleeding - occurred several times but could be controlled | 3 number of events |
| Ablation of the Prostate | Safety: Intraoperative Complications | Blood transfusion | 0 number of events |
| Ablation of the Prostate | Safety: Intraoperative Complications | Conversion to Transurethral resection procedure (TURP) to complete procedure | 1 number of events |
| Ablation of the Prostate | Safety: Intraoperative Complications | Conversion to TURP to maintain hemostasis | 0 number of events |
| Ablation of the Prostate | Safety: Intraoperative Complications | Capsule perforation | 0 number of events |
Primary
Safety: Perioperative Complications
Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia
Time frame: Post-procedure through 3 months
Population: All patients were assessed post-procedurally through the 3-month follow-up visit for number of Re-Catheterizations, Readmissions and other complications including Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ablation of the Prostate | Safety: Perioperative Complications | Peri-procedure Urgency (mild) | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Urgency (mild) at 1 month | 5 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Recatheterization | 2 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Readmission | 0 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Peri-procedure Urinary Retention (mild) | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Urinary retention (mild) at 1 month post procedure | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Urinary retention (moderate) at 1 month post procedure | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Urgency (mild) at 3 months | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Urinary Incontinence (mild) at 1 month | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Dysuria (mild) at 1 month | 2 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Dysuria (mild) at 3 months | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Peri-procedure Hematuria (mild) | 2 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Hematuria (mild) at 3 months post procedure | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Bleeding (mild) at hospital discharge | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Bleeding (mild) at 1 month post procedure | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Frequency (mild) 1 month post procedure | 3 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Frequency (mild) 3 months post procedure | 2 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Nocturia (mild) 1 month post procedure | 1 Events |
| Ablation of the Prostate | Safety: Perioperative Complications | Nocturia (mild) 3 months post procedure | 1 Events |
Secondary
Americal Urological Association (AUA) Symptom Index
The American Urological Association (AUA) Symptom Index assesses the severity of lower urinary tract symptoms in men, particularly related to benign prostatic hyperplasia. The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms related to benign prostatic hyperplasia (BPH).
Time frame: Baseline, 1-month and 3-month follow-up visits
Population: 20, 17, and 20 participants had evaluable data at baseline, 1-month and 3-month follow-up visits, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation of the Prostate | Americal Urological Association (AUA) Symptom Index | Baseline | 18.4 score on a scale | Standard Deviation 4.3 |
| Ablation of the Prostate | Americal Urological Association (AUA) Symptom Index | 1-month follow-up visit | 13.8 score on a scale | Standard Deviation 9.5 |
| Ablation of the Prostate | Americal Urological Association (AUA) Symptom Index | 3-month follow-up visit | 10.5 score on a scale | Standard Deviation 7.4 |
Secondary
Catheterization Time
Number of days catheter was in place post-ablation of the prostate
Time frame: Postoperatively through study completion up to 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ablation of the Prostate | Catheterization Time | 8 to 15 days | 16 Participants |
| Ablation of the Prostate | Catheterization Time | 4 to 7 days | 3 Participants |
| Ablation of the Prostate | Catheterization Time | Not provided | 1 Participants |
Secondary
Erectile Dysfunction
Sum score of International Index of Erectile Function (IIEF-5) questionnaire which measures erectile function, orgasmic function, sexual desire, and satisfaction. Each question is ranked 1-5 with a total sum score of 5 (severe erectile dysfunction) to 25 (normal function).
Time frame: Baseline and 3-month follow-up visit
Population: 19 participants had evaluable data at baseline, and 16 participants had evaluable data from the 3-month follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation of the Prostate | Erectile Dysfunction | Baseline | 6.1 score on a scale | Standard Deviation 4.9 |
| Ablation of the Prostate | Erectile Dysfunction | 3-Month Follow-up | 8.9 score on a scale | Standard Deviation 8.5 |
Secondary
Hospital Stay Duration
Number of days in hospital
Time frame: Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ablation of the Prostate | Hospital Stay Duration | 1 day | 20 Participants |
| Ablation of the Prostate | Hospital Stay Duration | >1 day | 0 Participants |
Secondary
International Prostate Symptom Score Quality of Life
The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). The Quality of Life question has a scale of 0-6, with 0=delighted and 6=terrible.
Time frame: Baseline, 1-month and 3-month follow-up visits
Population: 20 participants, 17 participants, and 18 participants had evaluable data at baseline, 1-month, and 3-month follow-up visits, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation of the Prostate | International Prostate Symptom Score Quality of Life | Baseline | 3.4 score on a scale | Standard Deviation 1.2 |
| Ablation of the Prostate | International Prostate Symptom Score Quality of Life | 1-Month Follow-up | 2.6 score on a scale | Standard Deviation 2.2 |
| Ablation of the Prostate | International Prostate Symptom Score Quality of Life | 3-Month Follow-up | 1.9 score on a scale | Standard Deviation 2 |
Secondary
Number of Fibers Used During Procedure
Number of fibers used during the BPH procedure
Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ablation of the Prostate | Number of Fibers Used During Procedure | 1 fiber used | 17 Participants |
| Ablation of the Prostate | Number of Fibers Used During Procedure | 2 fibers used | 3 Participants |
| Ablation of the Prostate | Number of Fibers Used During Procedure | 3 fibers used | 0 Participants |
Secondary
PSA (Prostate-specific Antigen)
Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels.
Time frame: Baseline and 3-month follow-up visit
Population: 15 participants and 19 participants had evaluable data at the baseline and 3-month interval, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation of the Prostate | PSA (Prostate-specific Antigen) | Baseline | 2.1 ng/mL | Standard Deviation 1.5 |
| Ablation of the Prostate | PSA (Prostate-specific Antigen) | 3-month follow-up visit | 2.1 ng/mL | Standard Deviation 1.4 |
Secondary
PVR (Post-void Residual)
Volume of urine remaining in the bladder after voiding, measured via ultrasound
Time frame: Baseline, 1-month and 3-month follow-up visits
Population: 20 participants had evaluable data at baseline and the 1-month follow-up visit. 19 participants had evaluable data at the 3-month follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation of the Prostate | PVR (Post-void Residual) | Baseline | 63.0 mL | Standard Deviation 60.5 |
| Ablation of the Prostate | PVR (Post-void Residual) | 1-month follow-up visit | 44.9 mL | Standard Deviation 31.8 |
| Ablation of the Prostate | PVR (Post-void Residual) | 3-month follow-up visit | 55.9 mL | Standard Deviation 40.8 |
Secondary
Qmax Uroflow
The maximum urine flow rate (Qmax) is a measure of the quantity of urine excreted in a specified period of time, expressed in cubic centimeters/second (cc/sec).
Time frame: Baseline, 1-month and 3-month follow-up visits
Population: 20 participants had evaluable data at baseline. 17 participants and 19 participants had evaluable data from the 1-month and 3-month follow-up visits, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation of the Prostate | Qmax Uroflow | Baseline | 7.3 cc/sec | Standard Deviation 3.9 |
| Ablation of the Prostate | Qmax Uroflow | 1-month follow-up visit | 12.8 cc/sec | Standard Deviation 6.6 |
| Ablation of the Prostate | Qmax Uroflow | 3-month follow-up visit | 9.4 cc/sec | Standard Deviation 5 |
Secondary
Visibility During Procedure
Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure
Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ablation of the Prostate | Visibility During Procedure | Poor | 0 Participants |
| Ablation of the Prostate | Visibility During Procedure | Fair | 0 Participants |
| Ablation of the Prostate | Visibility During Procedure | Good | 4 Participants |
| Ablation of the Prostate | Visibility During Procedure | Very Good | 7 Participants |
| Ablation of the Prostate | Visibility During Procedure | Excellent | 9 Participants |