Trial Outcomes & Findings for Study of Median Lobe Prostatic UroLift Procedure (NCT NCT02625545)

NCT ID: NCT02625545

Last Updated: 2019-02-26

Results Overview

The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-02-26

Participant Flow

Participant milestones

Measure	UroLift System Procedure All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Overall Study STARTED	45
Overall Study 3 Month	45
Overall Study 6 Month	45
Overall Study 12 Month	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Median Lobe Prostatic UroLift Procedure

Baseline characteristics by cohort

Measure	UroLift Arm n=45 Participants Subjects that undergo the UroLift System procedure.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
IPSS Baseline	24.2 Scores on a scale STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent to treat Population

The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.

Outcome measures

Measure	UroLift System Procedure n=45 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.	57.7 percent change Interval 50.8 to 63.8

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow up visit.

The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up Baseline IPSS	24.1 Score on a scale Standard Deviation 5.0
Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up 12 Month IPSS	10.6 Score on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up	-55.1 percent change Interval -63.6 to -46.6

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible).

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up Baseline QOL	4.9 score on a scale Standard Deviation 0.8
Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up 12 Month QOL	1.9 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible).

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up	-61.1 percent change Interval -69.5 to -52.7

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

BPHII (Benign Prostatic Hyperplasia Impact Index) is used to assess the impact of BPH symptoms on subject health and functioning. The BPHII is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Scores for each question range from 0 to 4, with higher score indicating greater impact. Maximum score is 16.

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up Baseline BPHII	7.7 BPHII score Standard Deviation 2.8
Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up 12 Month BPHII	2.1 BPHII score Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up	-70.4 percent change Interval -81.9 to -59.0

SECONDARY outcome

Timeframe: 12 Months

Population: 37/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. Includes only cases where voided volume is at least 125ml.

Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate.

Outcome measures

Measure	UroLift System Procedure n=37 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up 12 Month Qmax	13.5 mL/sec Standard Deviation 7.6
Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up Baseline Qmax	7.1 mL/sec Standard Deviation 2.7

SECONDARY outcome

Timeframe: 12 Months

Population: 37/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. Includes only cases where voided volume is at least 125ml.

Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate.

Outcome measures

Measure	UroLift System Procedure n=37 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up	108.4 percent change Interval 64.0 to 152.8

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner.

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up Baseline PVR	108.5 mL Standard Deviation 80.5
Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up 12 Month PVR	69.9 mL Standard Deviation 77.0

SECONDARY outcome

Timeframe: 12 Months

Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.

Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner.

Outcome measures

Measure	UroLift System Procedure n=44 Participants All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up	-4.8 percent change Interval -38.1 to 28.4

Adverse Events

UroLift System Procedure

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	UroLift System Procedure n=45 participants at risk All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Cardiac disorders Bradycardia/Heartblock	2.2% 1/45 • Number of events 1 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Nervous system disorders Cervical spinal stenosis	2.2% 1/45 • Number of events 1 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Musculoskeletal and connective tissue disorders Pain in hip	2.2% 1/45 • Number of events 1 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Gastrointestinal disorders Urinary tract infection	2.2% 1/45 • Number of events 1 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Respiratory, thoracic and mediastinal disorders Aspiration pneumonitis	2.2% 1/45 • Number of events 1 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events

Other adverse events

Measure	UroLift System Procedure n=45 participants at risk All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Renal and urinary disorders Haemorrhage urinary tract	57.8% 26/45 • Number of events 27 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Renal and urinary disorders Dysuria	48.9% 22/45 • Number of events 22 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Renal and urinary disorders Hematuria	26.7% 12/45 • Number of events 13 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Renal and urinary disorders Micturition urgency	8.9% 4/45 • Number of events 4 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Infections and infestations Urinary tract infection	15.6% 7/45 • Number of events 8 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Reproductive system and breast disorders Ejaculation disorder	6.7% 3/45 • Number of events 3 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Renal and urinary disorders Urge incontinence	6.7% 3/45 • Number of events 3 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Renal and urinary disorders Urinary retention	6.7% 3/45 • Number of events 3 • 12 Months Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events

Additional Information

Emily Hergenreter, Sr. Director of Clinical Affairs

NeoTract/Teleflex

Phone: 650-793-5570

Email: Emily.Hergenreter@Teleflex.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place