NCT01294150

The Safety and Effectiveness of UroLift: LIFT Pivotal Study

Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: NeoTract, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure. All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	UroLift System	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.
OTHER	Cystoscopy	The Control Group will undergo cystoscopy.
DEVICE	Crossover	Subjects crossed over and received the UroLift System from the Control Group.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-02-01
• Completion: 2017-07-05
• First posted: 2011-02-11
• Last updated: 2018-09-05
• Results posted: 2015-08-13

Locations

19 sites across 3 countries: United States, Australia, Canada