Trial Outcomes & Findings for BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia (NCT NCT01533038)

Last Updated: 2017-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Month 12

Results posted on

2017-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	45	35
Overall Study COMPLETED	45	34
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UroLift System n=45 Participants 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 n=35 Participants 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 n=80 Participants Total of all reporting groups
Age, Customized Age	63 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	35 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Denmark	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment United Kingdom	18 participants n=5 Participants	13 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment Germany	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Outcome measures

Outcome measures
Measure	UroLift System n=43 Participants 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 n=35 Participants 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.
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	52 % Responders of Participants	20 % Responders of Participants

Adverse Events

UroLift System

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Transurethral Resection of the Prostate

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	UroLift System n=45 participants at risk 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 n=35 participants at risk 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.
Gastrointestinal disorders Weak urinary stream	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Blood clot in urine	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Urge incontinence	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Urethral Stricture	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Epididymitis	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Incomplete Bladder Empyting	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)

Other adverse events

Additional Information

Director of Clinical Affairs

NeoTract

Phone: 925-401-0641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	UroLift System n=45 participants at risk 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 n=35 participants at risk 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.
Gastrointestinal disorders Bladder spasm	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	5.7% 2/35 • Number of events 2 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Bladder Tamponade	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Blood clot in urine	22.2% 10/45 • Number of events 10 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	42.9% 15/35 • Number of events 15 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Dysuria	37.8% 17/45 • Number of events 17 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	54.3% 19/35 • Number of events 19 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Epidymitis	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Erectile Dysfunction	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	8.6% 3/35 • Number of events 3 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Hemaeturia	15.6% 7/45 • Number of events 7 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	17.1% 6/35 • Number of events 6 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Incomplete bladder empyting	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Infection , urinary tract	8.9% 4/45 • Number of events 4 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	5.7% 2/35 • Number of events 3 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Lower urinary tract symptoms	4.4% 2/45 • Number of events 2 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Nocturia	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Pain, Abdominal	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Pain, Groin	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Pelvic Pain	11.1% 5/45 • Number of events 5 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	8.6% 3/35 • Number of events 3 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Post-void dribble	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	5.7% 2/35 • Number of events 2 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Prostatic greenlight laser vaporization	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Prosthesis calcification	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Residual urine volume increase	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	2.9% 1/35 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Retrograde Ejaculation	0.00% 0/45 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	20.0% 7/35 • Number of events 7 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Stone, urinary bladder	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	0.00% 0/35 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Urge Incontinence	2.2% 1/45 • Number of events 1 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	17.1% 6/35 • Number of events 6 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Urinary Frequency	8.9% 4/45 • Number of events 4 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	11.4% 4/35 • Number of events 4 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Urinary urgency	11.1% 5/45 • Number of events 5 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	25.7% 9/35 • Number of events 9 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)
Gastrointestinal disorders Weak urinary stream	4.4% 2/45 • Number of events 2 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)	5.7% 2/35 • Number of events 2 • SAEs Adjudication through 12M; AEs through 24M-(2 years post-Index)