Clinical trial NCT04997369: Catheterless Water Vapor Therapy for the Treatment of BPH
Official title: Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Water Vapor Therapy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2021-08-09
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
timeFrame: Baseline, 36 months
measure: Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
timeFrame: Baseline, 36 months
Secondary outcomes:
measure: Changes in urinary symptoms as measured by changes in IPSS.
timeFrame: Baseline, 36 months
measure: Changes in urinary symptoms as measured by changes in Qmax at 36 months
timeFrame: Baseline, 36 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Bilal Chughtai, MD
role: PRINCIPAL_INVESTIGATOR
References: