Catheterless Water Vapor Therapy for the Treatment of BPH

NCT ID: NCT04997369

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2027-06-30

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Water Vapor Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Catheterless group

Group Type: EXPERIMENTAL

Rezum

Intervention Type: DEVICE

The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).

Interventions

Rezum

The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).

Intervention Type: DEVICE

Other Intervention Names

Water vapor therapy

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bilal Chughtai, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

20-02021474

Identifier Type: -

Identifier Source: org_study_id