Catheterless Water Vapor Therapy for the Treatment of BPH

Study Overview
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Brief Summary
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The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.

Official Title
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Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Rezum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subject of 40 - 80 years of age Has provided informed consent Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement Able to complete self-administered questionnaires Is a surgical candidate for Rezum Has medical record documentation of Qmax < 15 ml/s Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS) Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax). Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention. Has serum creatinine within the normal range. Able to perform intermittent catheterization. Exclusion Criteria: Has a life expectancy < 2 years Is currently enrolled in or plans to enroll in any concurrent drug or device study Has an active infection (e.g., urinary tract infection or prostatitis) Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis) Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years Has a diagnosis of lichen sclerosis Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function Has a diagnosis of polyneuropathy (e.g., diabetic) Has a history of lower urinary tract surgery Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use Has an inability to perform intermittent self-catheterization Has been catheterized or has a post-void residual (PVR) of > 400 ml in the 14 days prior to the surgical procedure Has a current diagnosis of bladder stones

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheterless group<br> | Device: Rezum<br>* The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).<br>* Other names: Water vapor therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS). | The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity. | Baseline, 36 months | 
| Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax). | The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction. | Baseline, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urinary symptoms as measured by changes in IPSS. | The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity. | Baseline, 36 months | 
| Changes in urinary symptoms as measured by changes in Qmax at 36 months | The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction. | Baseline, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Water Vapor Therapy