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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.
 
ClinicalTrials.gov Identifier: NCT01533038
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : November 26, 2015
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.

Tracking Information
First Submitted Date  ICMJE February 10, 2012
First Posted Date  ICMJE February 15, 2012
Results First Submitted Date  ICMJE October 22, 2015
Results First Posted Date  ICMJE November 26, 2015
Last Update Posted Date December 19, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia
Official Title  ICMJE BPH-6: A UroLift® System Post Market Multi-Center Randomized Study
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2015)
80
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2012)
100
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Germany,   United Kingdom
Removed Location Countries Canada,   Italy
 
Administrative Information
NCT Number  ICMJE NCT01533038
Other Study ID Numbers  ICMJE CP12317
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NeoTract, Inc.
Study Sponsor  ICMJE NeoTract, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco Montorsi, MD University Vita Salute San Raffaele
PRS Account NeoTract, Inc.
Verification Date November 2017

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