This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatment urolift® system
Sponsor NeoTract, Inc.
Start date April 2013
End date September 2013
Trial size 51 participants
Trial identifier NCT01876706, CP12911


The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Single-arm of qualified subjects receiving UroLift® System intervention.
urolift® system
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 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.

Primary Outcomes

Quality of Recovery
time frame: 1 Month

Secondary Outcomes

Resolution of BPH, Procedural Recovery Measures, and Health Economics
time frame: 12 Months

Eligibility Criteria

Male participants at least 50 years old.

Inclusion Criteria: - Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH) Exclusion Criteria: - Size, volume,length of prostate

Additional Information

Official title L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Description The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by NeoTract, Inc..