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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533038
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : November 26, 2015
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):
NeoTract, Inc.

February 10, 2012
February 15, 2012
October 22, 2015
November 26, 2015
December 19, 2017
February 2012
October 2015   (Final data collection date for primary outcome measure)
Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met [ Time Frame: Month 12 ]
  1. LUTS: ≥ 30% reduction in IPSS compared to baseline
  2. Recovery Experience: Return to pre-operative activity levels by 1 month
  3. Erectile function: Less than 6-point reduction in SHIM compared to baseline.
  4. Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate"
  5. Continence: ISI score of 4 points or less at all follow-up time points
  6. Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up.
Same as current
Complete list of historical versions of study NCT01533038 on Archive Site
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BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
BPH-6: A UroLift® System Post Market Multi-Center Randomized Study
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • 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.
  • Active Comparator: UroLift System
    UroLift System procedure
    Intervention: Device: UroLift System
  • Active Comparator: Transurethral Resection of the Prostate
    Transurethral Resection of the Prostate surgery
    Intervention: Procedure: Transurethral Resection of the Prostate
Sønksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2016
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

• Men >50 years old with moderate-severe BPH

Exclusion Criteria:

  • Size, width of prostate
  • Other medical condition or co-morbidity contraindicative for TURP or UroLift
Sexes Eligible for Study: Male
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   United Kingdom
Canada,   Italy
Not Provided
Plan to Share IPD: No
NeoTract, Inc.
NeoTract, Inc.
Not Provided
Principal Investigator: Francesco Montorsi, MD University Vita Salute San Raffaele
NeoTract, Inc.
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP