NCT01912339

Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)

Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Detailed description

This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptom

Interventions

Type	Name	Description
DEVICE	Rezum System	The Rezūm System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland. A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum. A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices. Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death.
PROCEDURE	Rigid Cystoscopy	Endoscopy of the urinary bladder via the urethra.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-03-01
• Completion: 2016-10-17
• First posted: 2013-07-31
• Last updated: 2020-04-13
• Results posted: 2017-05-15

Locations

15 sites across 1 country: United States