Benign Prostatic Hyperplasia
Conditions
Keywords
Water Vapor Therapy
Brief summary
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.
Interventions
DEVICERezum
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).
Sponsors
Boston Scientific Corporation
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS). | Baseline, 36 months | 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. |
| Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax). | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in urinary symptoms as measured by changes in IPSS. | Baseline, 36 months | 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. |
| Changes in urinary symptoms as measured by changes in Qmax at 36 months | Baseline, 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. |
Countries
United States
Outcome results
None listed