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

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Benign Prostatic Hyperplasia
Interventions Device: UroLift System
Procedure: Transurethral Resection of the Prostate
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title UroLift System Transurethral Resection of the Prostate
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 45 35
Completed 45 34
Not Completed 0 1
Arm/Group Title UroLift System Transurethral Resection of the Prostate Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 45 35 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 45 participants 35 participants 80 participants
63
(49 to 84)
65
(51 to 78)
65
(49 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 35 participants 80 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
45
 100.0%
35
 100.0%
80
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 35 participants 80 participants
Denmark 10 9 19
United Kingdom 18 13 31
Germany 17 13 30
1.Primary Outcome
Title 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
Hide Description
  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.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UroLift System Transurethral Resection of the Prostate
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 43 35
Measure Type: Number
Unit of Measure: % Responders of Participants
52 20
Time Frame SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title UroLift System Transurethral Resection of the Prostate
Hide Arm/Group Description

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 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.

All-Cause Mortality
UroLift System Transurethral Resection of the Prostate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
UroLift System Transurethral Resection of the Prostate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/45 (4.44%)      4/35 (11.43%)    
Gastrointestinal disorders     
Weak urinary stream  1  1/45 (2.22%)  1 0/35 (0.00%)  0
Blood clot in urine  2  0/45 (0.00%)  0 1/35 (2.86%)  1
Urge incontinence  2  0/45 (0.00%)  0 1/35 (2.86%)  1
Urethral Stricture  2  0/45 (0.00%)  0 1/35 (2.86%)  1
Epididymitis  2  0/45 (0.00%)  0 1/35 (2.86%)  1
Incomplete Bladder Empyting  2  1/45 (2.22%)  1 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Meddra version 15.0
2
Term from vocabulary, Meddra
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
UroLift System Transurethral Resection of the Prostate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/45 (73.33%)      28/35 (80.00%)    
Gastrointestinal disorders     
Bladder spasm  1  1/45 (2.22%)  1 2/35 (5.71%)  2
Bladder Tamponade  1  1/45 (2.22%)  1 1/35 (2.86%)  1
Blood clot in urine  1  10/45 (22.22%)  10 15/35 (42.86%)  15
Dysuria  1  17/45 (37.78%)  17 19/35 (54.29%)  19
Epidymitis  1  0/45 (0.00%)  0 1/35 (2.86%)  1
Erectile Dysfunction  1  0/45 (0.00%)  0 3/35 (8.57%)  3
Hemaeturia  1  7/45 (15.56%)  7 6/35 (17.14%)  6
Incomplete bladder empyting  1  1/45 (2.22%)  1 1/35 (2.86%)  1
Infection , urinary tract  1  4/45 (8.89%)  4 2/35 (5.71%)  3
Lower urinary tract symptoms  1  2/45 (4.44%)  2 0/35 (0.00%)  0
Nocturia  1  1/45 (2.22%)  1 1/35 (2.86%)  1
Pain, Abdominal  1  1/45 (2.22%)  1 0/35 (0.00%)  0
Pain, Groin  1  0/45 (0.00%)  0 1/35 (2.86%)  1
Pelvic Pain  1  5/45 (11.11%)  5 3/35 (8.57%)  3
Post-void dribble  1  0/45 (0.00%)  0 2/35 (5.71%)  2
Prostatic greenlight laser vaporization  1  0/45 (0.00%)  0 0/35 (0.00%)  0
Prosthesis calcification  1  1/45 (2.22%)  1 0/35 (0.00%)  0
Residual urine volume increase  1  0/45 (0.00%)  0 1/35 (2.86%)  1
Retrograde Ejaculation  1  0/45 (0.00%)  0 7/35 (20.00%)  7
Stone, urinary bladder  1  1/45 (2.22%)  1 0/35 (0.00%)  0
Urge Incontinence  1  1/45 (2.22%)  1 6/35 (17.14%)  6
Urinary Frequency  1  4/45 (8.89%)  4 4/35 (11.43%)  4
Urinary urgency  1  5/45 (11.11%)  5 9/35 (25.71%)  9
Weak urinary stream  1  2/45 (4.44%)  2 2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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
Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01533038     History of Changes
Other Study ID Numbers: CP12317
First Submitted: February 10, 2012
First Posted: February 15, 2012
Results First Submitted: October 22, 2015
Results First Posted: November 26, 2015
Last Update Posted: December 19, 2017