US-based NXThera has completed patient enrolment in its Rezum II IDE clinical trial to treat benign prostatic hyperplasia (BPH).
The multi-centre clinical trial evaluated the use of the Rezum system for treatment of obstructive prostate tissue by convectively delivering sterile water vapor directly into the prostate in a minimally invasive procedure.
A total of 195 men aged 50 or above were enrolled in the trial in the US. They were treated with the Rezum system versus a control procedure in a randomised method of two-to-one.
Southern Illinois University professor and chairman of urology Kevin McVary and University of Texas Southwestern professor and chairman of urology Claus Roehrborn said: "The Rezum II clinical trial is designed to collect comprehensive information for review and evaluation by FDA and physicians.
"We look forward to completing the required follow-up assessments and evaluating patients’ outcomes in conjunction with the promising data previously reported from NxThera’s single-arm Rezum trials."
The normal flow of urine from the bladder can be restricted in ageing men, often as the result of enlarged prostate tissue that obstructs the urethra.
Symptoms of benign prostatic hyperplasia include increased frequency of urination, sudden urges to urinate and weak urine flow.
In the US, more than 32 million men, including more than 70% of men aged 60 and older, experience symptoms of BPH, which if left untreated can result in more serious conditions such as incontinence, bladder or kidney damage or bladder stones.
The new Rezum system is designed to offer sustained symptom relief without the side-effects associated with other treatments or procedures, the company said.
NxThera president and CEO Bob Paulson said: "It was very rewarding and exciting to see independent clinical study teams at 14 US sites complete recruitment and enrolment of the Rezum II trial in just 44 weeks, which speaks to the number of men who are seeking alternatives to currently available BPH treatments and procedures.
"We look forward to filing our submission with FDA in 2015 to seek US market clearance of the Rezum system, and the opportunity to offer a new treatment option to urologists and the millions of their patients who suffer from BPH."