At a glance
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Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms
In Brief
A clinical study evaluating UroLift System, Cystoscopy, and 1 other intervention for Benign Prostatic Hyperplasia. Completed, enrolled 206 participants across 19 sites in 3 countries.
Detailed Summary
The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.
Study Details
Timeline
Interventions
The NeoTract UroLift System is a medical device approved for sale in the United States, European Union, and several other countries (see www.urolift.com). It was developed for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
The Control Group will undergo cystoscopy.
Subjects crossed over and received the UroLift System from the Control Group.