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Completed

NCT Number: NCT01876706

UroLift System TOlerability and ReCovery When Administering Local Anesthesia

The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

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Key information

Conditions

Benign Prostatic Hyperplasia 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

Primary location

Genesis Research LLC, San Diego, California, United States

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About this study

The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion criteria

  • Size, volume,length of prostate

Treatment and study plan

UroLift® System

Device

The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 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.

Primary outcomes

  1. Quality of Recovery

    Time frame: 1 Month

    Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.

Secondary outcomes

  1. IPSS Scores at Baseline and 12 Month Follow-up

    Time frame: 12 Months

    The International Prostate Symptom Score (IPSS) is an 7 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). Lower scores are indicative of less symptoms.

    Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic

  2. IPSS 12 Month Change From Baseline

    Time frame: 12 Months

    The International Prostate Symptom Score (IPSS) is an 7 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) using a total score from 0 - 35.

    The larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS.

  3. IPSS 12 Month Percent (%) Change From Baseline

    Time frame: 12 Months

    The International Prostate Symptom Score (IPSS) is an 7 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) using a total score from 0 - 35.

    The larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject.

  4. BPH II Scores at Baseline and 12 Month Follow-up

    Time frame: 12 Month

    BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.

    Questions 1-4:

    • Over the past month how much physical discomfort did any urinary problems cause you? &
    • Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    • Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
    • Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.

  5. BPH II 12 Month Percent (%) Change From Baseline

    Time frame: 12 Months

    BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.

    Questions 1-4:

    • Over the past month how much physical discomfort did any urinary problems cause you? &
    • Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    • Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
    • Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.

  6. BPH II 12 Month Change From Baseline

    Time frame: 12 Months

    BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.

    Questions 1-4:

    • Over the past month how much physical discomfort did any urinary problems cause you? &
    • Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    • Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
    • Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.

  7. Qmax Scores at Baseline and 12 Month Follow-up

    Time frame: 12 Month

    QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.

  8. QMAX 12 Month Change Minus Baseline

    Time frame: 12 Months

    QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX

  9. QMAX 12 Month Percent (%) Change in mL/Sec From Baseline

    Time frame: 12 Months

    QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject

  10. Pain Tolerability Throughout the UroLift System Procedure

    Time frame: 12 Month

    Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.

  11. BPHII Baseline and 12 Month Median Score, 95% CI

    Time frame: 12 Month

    BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.

    Questions 1-4:

    • Over the past month how much physical discomfort did any urinary problems cause you? &
    • Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    • Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
    • Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.

  12. IPSS at Baseline and 12 Months, Median , 95% CI

    Time frame: 12 Month

    The International Prostate Symptom Score (IPSS) is an 7 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). Lower scores are indicative of less symptoms.

    Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic

  13. QMAX Median at Baseline and 12 Months With CI 95%

    Time frame: 12 Month

    QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.

Sponsors and collaborators

Lead sponsor

NeoTract, Inc.

Industry

Registry information

Official study title

L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia

Acronym: LOCAL

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Jun 13, 2013
Registry last updated
Mar 20, 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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