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Completed

NCT Number: NCT02625545

Study of Median Lobe Prostatic UroLift Procedure

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).

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

UroLift System Procedure

Device

Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH

Other names: Prostatic UroLift (PUL)

Primary outcomes

  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%.

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NeoTract, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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