US-based NxThera has announced the successful treatment of first patients in NxThera's Rezum II US clinical trial designed for the treatment of benign prostatic hyperplasia (BPH).
The Rezum II clinical trial, a randomised controlled study, will evaluate the safety and efficacy of the Rezum system and assess its effect on urinary symptoms secondary to BPH.
Increased frequency of urination, sudden urges to urinate, and weak urine flows are few symptoms of BPH.
The study expects to enrol a total of 195 male patients with age 50 and older with urinary problems related to BPH at 15 sites in the US.
The Rezum system uses sterile water vapor to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland.
Designed to be performed in an office-based, outpatient or in-hospital setting, the Rezum treatment can be delivered in seconds, with a total procedure time measured in minutes.
Southern Illinois University chair of the division of urology Dr Kevin McVary and UT Southwestern chair of the department of urology Dr Claus Roehrborn are the co-principal investigators for the Rezum II IDE trial.
In ageing men, the normal flow of urine from the bladder can be restricted, often as the result of enlarged prostate tissue that obstructs the urethra.
More than 12 million US men have been diagnosed with BPH, while more than 70% of men older than 60 experience symptoms of BPH.
Western Urological Clinic and Jean Brown Research Dr Steven Gange in Salt Lake City, Utah, said millions of men who suffer from the effects of BPH are unable to obtain relief using pharmacologic therapies, and are unwilling to accept the potential complications or side effects associated with other BPH procedures.
"Many of these men are seeking treatment options that can be performed quickly, with minimal side effects and rapid recovery," Dr Gange said.
The company believes the Rezum System can deliver better patient outcomes as it causes minimal discomfort, provides rapid symptom relief by alleviating obstruction of the urethra and preserves normal sexual function.
The NxThera Rezum system is an investigational device and currently not available for sale in the US.