NCT01533038

BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia

BPH-6: A UroLift® System Post Market Multi-Center Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: NeoTract, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

Detailed description

The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects. Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	UroLift System	The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and 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.
PROCEDURE	Transurethral Resection of the Prostate	Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck.

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2012-02-15
• Last updated: 2017-12-19
• Results posted: 2015-11-26

Locations

9 sites across 3 countries: Denmark, Germany, United Kingdom