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Study of Median Lobe Prostatic UroLift Procedure

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UroLift System procedure
Sponsored by
NeoTract, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    UroLift System procedure

    Arm Description

    All eligible,enrolled subjects will undergo a UroLift procedure

    Outcomes

    Primary Outcome Measures

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

    Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up
    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.
    Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up
    Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up
    Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up
    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).
    Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up
    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).
    Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up
    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.
    Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up
    Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up
    Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up
    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.
    Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up
    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.
    Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up
    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.
    Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up
    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.

    Full Information

    First Posted
    December 5, 2015
    Last Updated
    February 5, 2019
    Sponsor
    NeoTract, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02625545
    Brief Title
    Study of Median Lobe Prostatic UroLift Procedure
    Official Title
    Study of Median Lobe Prostatic UroLift Procedure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 17, 2016 (Actual)
    Primary Completion Date
    May 30, 2017 (Actual)
    Study Completion Date
    December 19, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NeoTract, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia (BPH)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    UroLift System procedure
    Arm Type
    Experimental
    Arm Description
    All eligible,enrolled subjects will undergo a UroLift procedure
    Intervention Type
    Device
    Intervention Name(s)
    UroLift System procedure
    Other Intervention Name(s)
    Prostatic UroLift (PUL)
    Intervention Description
    Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
    Primary Outcome Measure Information:
    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
    Secondary Outcome Measure Information:
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Enlarged median lobe (ML) contributing to obstruction of the prostate BPH Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan B. Rukstalis, M.D.
    Organizational Affiliation
    Wake Forest
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of Median Lobe Prostatic UroLift Procedure

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