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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.
ClinicalTrials.gov Identifier:
NCT01533038
First received: February 10, 2012
Last updated: February 18, 2016
Last verified: February 2016
Results First Received: October 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia
Interventions: Device: UroLift System
Procedure: Transurethral Resection of the Prostate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
UroLift System

UroLift System procedure

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.

Transurethral Resection of the Prostate

Transurethral Resection of the Prostate surgery

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.


Participant Flow:   Overall Study
    UroLift System     Transurethral Resection of the Prostate  
STARTED     45     35  
COMPLETED     45     34  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
UroLift System

UroLift System procedure

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.

Transurethral Resection of the Prostate

Transurethral Resection of the Prostate surgery

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.

Total Total of all reporting groups

Baseline Measures
    UroLift System     Transurethral Resection of the Prostate     Total  
Number of Participants  
[units: participants]
  45     35     80  
Age, Customized  
[units: years]
Mean (Full Range)
     
Age     63  
  (49 to 84)  
  65  
  (51 to 78)  
  65  
  (49 to 84)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     45     35     80  
Region of Enrollment  
[units: participants]
     
Denmark     10     9     19  
United Kingdom     18     13     31  
Germany     17     13     30  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Affairs
Organization: NeoTract
phone: 925-401-0641
e-mail: ehergenreter@neotract.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01533038     History of Changes
Other Study ID Numbers: CP12317
Study First Received: February 10, 2012
Results First Received: October 22, 2015
Last Updated: February 18, 2016
Health Authority: Germany: Ethics Commission