Catheterless Water Vapor Therapy for the Treatment of BPH
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT04997369
- Lead Sponsor
- Northwell Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Male subject of 40 - 80 years of age<br><br> - Has provided informed consent<br><br> - Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement<br><br> - Able to complete self-administered questionnaires<br><br> - Is a surgical candidate for Rezum<br><br> - Has medical record documentation of Qmax < 15 ml/s<br><br> - Has medical record documentation of prostate volume from 30-80 ml by transrectal<br> ultrasound (TRUS)<br><br> - Has a bladder contractility index score = 100, calculated by detrusor pressure at<br> Qmax (pDet@qmax) + (5xQmax).<br><br> - Willing to undergo pressure-flow studies to calculate BCI prior to surgical<br> intervention.<br><br> - Has serum creatinine within the normal range.<br><br> - Able to perform intermittent catheterization.<br><br>Exclusion Criteria:<br><br> - Has a life expectancy < 2 years<br><br> - Is currently enrolled in or plans to enroll in any concurrent drug or device study<br><br> - Has an active infection (e.g., urinary tract infection or prostatitis)<br><br> - Has a diagnosis of or has received treatment for chronic prostatitis or chronic<br> pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)<br><br> - Has been diagnosed with a urethral stricture or bladder neck contracture within the<br> last 180 days<br><br> - Has been diagnosed with 2 or more urethral strictures and/or bladder neck<br> contractures within 5 years<br><br> - Has a diagnosis of lichen sclerosis<br><br> - Has a diagnosis of neurogenic bladder or other neurologic disorder that affects<br> bladder function<br><br> - Has a diagnosis of polyneuropathy (e.g., diabetic)<br><br> - Has a history of lower urinary tract surgery<br><br> - Has a diagnosis of stress urinary incontinence that requires treatment or daily pad<br> or device use<br><br> - Has an inability to perform intermittent self-catheterization<br><br> - Has been catheterized or has a post-void residual (PVR) of > 400 ml in the 14 days<br> prior to the surgical procedure<br><br> - Has a current diagnosis of bladder stones
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).;Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
- Secondary Outcome Measures
Name Time Method Changes in urinary symptoms as measured by changes in IPSS.;Changes in urinary symptoms as measured by changes in Qmax at 36 months