Trial Outcomes & Findings for Urodynamic Feasibility Study Utilizing the UroLift® System (NCT NCT04271020)

NCT ID: NCT04271020

Last Updated: 2020-06-11

Results Overview

Qmax is the the maximum urinary flow rate measured in ml/s.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 3 Month
• Results posted on: 2020-06-11

Participant Flow

Participant milestones

Measure	UroLift UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	UroLift n=12 Participants UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.
Age, Customized Age	57.44 years STANDARD_DEVIATION 6.33 • n=12 Participants
Sex: Female, Male Female	0 Participants n=12 Participants
Sex: Female, Male Male	12 Participants n=12 Participants
Qmax	7.0 mL/sec STANDARD_DEVIATION 2.7 • n=12 Participants
Pdet @ Qmax	79.9 cmH20 STANDARD_DEVIATION 25.2 • n=9 Participants • Unable to interpret data from 3 subjects collected at baseline.
Pdetmax	108.9 cmH20 STANDARD_DEVIATION 34.4 • n=9 Participants • Unable to interpret data from 3 subjects collected at baseline.

PRIMARY outcome

Timeframe: 3 Month

Qmax is the the maximum urinary flow rate measured in ml/s.

Outcome measures

Measure

UroLift n=12 Participants UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.

Qmax Assessed Using Urodynamic Testing (Cystometry)

14.0 mL/sec Standard Deviation 8.4

PRIMARY outcome

Timeframe: 3 Month

Population: Overall number of participants analyzed is fewer than the total number of participants (12) and number of participants analyzed at baseline (8) because unable to interpret data collected at 3 months.

Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.

Outcome measures

Measure

UroLift n=8 Participants UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.

Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)

82.4 cm H2O Standard Deviation 21.9

PRIMARY outcome

Timeframe: 3 Month

Population: Overall number of participants analyzed is fewer than the total number of participants (12) and number of participants analyzed at baseline (8) because unable to interpret data collected at 3 months.

Pdetmax is the maximum void pressure measured in cm H2O.

Outcome measures

Measure

UroLift n=8 Participants UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.

Pdetmax Assessed Using Urodynamic Testing (Cystometry)

101.5 cm H2O Standard Deviation 30.7

Adverse Events

UroLift

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

UroLift n=12 participants at risk UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.

Renal and urinary disorders Urinary retention

8.3% 1/12 • Number of events 1 • Adverse event data was collected for 1 day, until the AE was resolved, during the 1-3 Day Visit after release from procedure time frame. Not applicable - Adverse event and/or serious adverse event definition used in this study is the same as defined on clinicaltrials.gov.

Additional Information

Emily Friedland, Director, Global Clinical Affairs

NeoTract, Inc.

Phone: 1-610-331-7299

Email: emily.friedland@teleflex.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI agree not to make any Publications of Study results until completion of the Study and Publication of the results in a peer-reviewed journal by Sponsor. Thereafter, PI may publish their individual site experience. Should a manuscript not be submitted by Sponsor within 12 months of study closure, PI may publish study results. PI shall provide Sponsor 30 days prior notice of publication submission date and text of proposed Publication for review.
• Publication restrictions are in place

Restriction type: OTHER