Catheterless Water Vapor Therapy for the Treatment of BPH

Northwell Health

Status

Suspended

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: Rezum

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04997369

20-02021474

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Male

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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