Study of Median Lobe Prostatic UroLift Procedure

• Sponsor: NeoTract, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02625545
• Collaborator: (none)
• Enrollment: 45
• Arm: 1
• Actual Duration (Months): 22

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia (BPH)	Device: UroLift System procedure	N/A

Detailed Description

Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.

Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.

Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Median Lobe Prostatic UroLift Procedure
• Actual Study Start Date: Feb 17, 2016
• Actual Primary Completion Date: May 30, 2017
• Actual Study Completion Date: Dec 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UroLift System procedure All eligible,enrolled subjects will undergo a UroLift procedure	Device: UroLift System procedure; Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH; Other Names: Prostatic UroLift (PUL)

Outcome Measures

Primary Outcome Measures

1. At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. [6 months]

   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.

Secondary Outcome Measures

1. Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up [12 Months]

   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.

2. Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up [12 Months]

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

3. Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up [12 Months]

   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).

4. Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up [12 Months]

   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).

5. Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up [12 Months]

   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.

6. Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up [12 Months]

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

7. Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up [12 Months]

   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.

8. Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up [12 Months]

   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.

9. Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up [12 Months]

   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.

10. Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up [12 Months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Enlarged median lobe (ML) contributing to obstruction of the prostate

• BPH

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NeoTract, Inc.

Investigators

• Principal Investigator: Dan B. Rukstalis, M.D., Wake Forest

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 24, 2018

More Information

Publications

None provided.

• Responsible Party: NeoTract, Inc.
• ClinicalTrials.gov Identifier: NCT02625545
• Other Study ID Numbers: CP00001
• First Posted: Dec 9, 2015
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

Participant Flow

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Period Title: Overall Study
STARTED	45
3 Month	45
6 Month	45
12 Month	45
COMPLETED	45
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	UroLift Arm
Arm/Group Description	Subjects that undergo the UroLift System procedure.
Overall Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 57.8%
>=65 years	19 42.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (7.0)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	45 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.4%
Not Hispanic or Latino	42 93.3%
Unknown or Not Reported	1 2.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 4.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 4.4%
White	40 88.9%
More than one race	0 0%
Unknown or Not Reported	1 2.2%
Region of Enrollment (participants) [Number]
United States	45 100%
IPSS Baseline (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	24.2 (4.9)

Outcome Measures

1. Primary Outcome

Title	At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intent to treat Population

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	45
Mean (95% Confidence Interval) [percent change]	57.7

2. Secondary Outcome

Title	Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Baseline IPSS	24.1 (5.0)
12 Month IPSS	10.6 (7)

3. Secondary Outcome

Title	Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up
Description	Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Mean (95% Confidence Interval) [percent change]	-55.1

4. Secondary Outcome

Title	Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up
Description	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).
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Baseline QOL	4.9 (0.8)
12 Month QOL	1.9 (1.3)

5. Secondary Outcome

Title	Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up
Description	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).
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Mean (95% Confidence Interval) [percent change]	-61.1

6. Secondary Outcome

Title	Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Baseline BPHII	7.7 (2.8)
12 Month BPHII	2.1 (2.5)

7. Secondary Outcome

Title	Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up
Description	Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Mean (95% Confidence Interval) [percent change]	-70.4

8. Secondary Outcome

Title	Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	37
Baseline Qmax	7.1 (2.7)
12 Month Qmax	13.5 (7.6)

9. Secondary Outcome

Title	Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	37
Mean (95% Confidence Interval) [percent change]	108.4

10. Secondary Outcome

Title	Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Baseline PVR	108.5 (80.5)
12 Month PVR	69.9 (77.0)

11. Secondary Outcome

Title	Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
Measure Participants	44
Mean (95% Confidence Interval) [percent change]	-4.8

Adverse Events

Time Frame	12 Months
Adverse Event Reporting Description	Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Arm/Group Title	UroLift System Procedure
Arm/Group Description	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
All Cause Mortality
	UroLift System Procedure
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Serious Adverse Events
	UroLift System Procedure
	Affected / at Risk (%)	# Events
Total	5/45 (11.1%)
Cardiac disorders
Bradycardia/Heartblock	1/45 (2.2%)	1
Gastrointestinal disorders
Urinary tract infection	1/45 (2.2%)	1
Musculoskeletal and connective tissue disorders
Pain in hip	1/45 (2.2%)	1
Nervous system disorders
Cervical spinal stenosis	1/45 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis	1/45 (2.2%)	1
Other (Not Including Serious) Adverse Events
	UroLift System Procedure
	Affected / at Risk (%)	# Events
Total	36/45 (80%)
Infections and infestations
Urinary tract infection	7/45 (15.6%)	8
Renal and urinary disorders
Haemorrhage urinary tract	26/45 (57.8%)	27
Dysuria	22/45 (48.9%)	22
Hematuria	12/45 (26.7%)	13
Micturition urgency	4/45 (8.9%)	4
Urge incontinence	3/45 (6.7%)	3
Urinary retention	3/45 (6.7%)	3
Reproductive system and breast disorders
Ejaculation disorder	3/45 (6.7%)	3

Limitations/Caveats

[Not Specified]

More Information

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.