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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01294150
Other study ID # 1012CP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2011
Est. completion date July 5, 2017

Study information

Verified date August 2018
Source NeoTract, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date July 5, 2017
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion Criteria:

- Size, volume,length of prostate

Study Design


Intervention

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.

Locations

Country Name City State
Australia Figtree Private Hospital Figtree New South Wales
Australia Austin Hospital Heidelberg Victoria
Australia Port Macquarie Urology Centre Port Macquarie
Canada Oakville Trafalgar Memorial Hospital Oakville Ontario
Canada Cam Am HIFU Toronto Ontario
United States Chesapeake Urology Baltimore Maryland
United States Northwestern University Chicago Illinois
United States UT Southwestern Medical Center Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Advanced Urology Institute Daytona Beach Florida
United States Urology Associates of Denver Englewood Colorado
United States Sheldon J. Freedman, M.D., Ltd. Las Vegas Nevada
United States Carolina Urologic Research Center Myrtle Beach South Carolina
United States Weill Cornell Medical College New York New York
United States Pinellas Urology Saint Petersburg Florida
United States Jean Brown Research Salt Lake City Utah
United States Genesis Research LLC San Diego California
United States Shahram S. Gholami MD - A Professional Corp. San Jose California
United States Scott and White Healthcare Temple Texas

Sponsors (1)

Lead Sponsor Collaborator
NeoTract, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Collection of Post-treatment Catheterization for Safety The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint. Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
Primary Comparison of IPSS for Efficacy The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.
The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).
SCORING:
0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
3 month
Primary Mean UroLift Improvement in IPSS at 12 Months The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%. 12 months
Secondary Sexual Function Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months. 12 Months
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