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UroLift System TOlerability and ReCovery When Administering Local Anesthesia (LOCAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.
ClinicalTrials.gov Identifier:
NCT01876706
First received: May 6, 2013
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Benign Prostatic Hyperplasia
Device: UroLift® System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia

Resource links provided by NLM:


Further study details as provided by NeoTract, Inc.:

Primary Outcome Measures:
  • Quality of Recovery [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • IPSS Scores at Baseline and 12 Month Follow-up [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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


  • IPSS 12 Month Change From Baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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.


  • IPSS 12 Month Percent (%) Change From Baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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.


  • BPH II Scores at Baseline and 12 Month Follow-up [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

    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:

    1. Over the past month how much physical discomfort did any urinary problems cause you? &
    2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    3. 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.
    4. 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.

  • BPH II 12 Month Percent (%) Change From Baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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:

    1. Over the past month how much physical discomfort did any urinary problems cause you? &
    2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    3. 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.
    4. 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.

  • BPH II 12 Month Change From Baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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:

    1. Over the past month how much physical discomfort did any urinary problems cause you? &
    2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    3. 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.
    4. 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.

  • Qmax Scores at Baseline and 12 Month Follow-up [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
    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.

  • QMAX 12 Month Change Minus Baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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

  • QMAX 12 Month Percent (%) Change in mL/Sec From Baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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

  • Pain Tolerability Throughout the UroLift System Procedure [ Time Frame: 12 Month ] [ Designated as safety issue: Yes ]
    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.

  • BPHII Baseline and 12 Month Median Score, 95% CI [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

    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:

    1. Over the past month how much physical discomfort did any urinary problems cause you? &
    2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
    3. 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.
    4. 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.

  • IPSS at Baseline and 12 Months, Median , 95% CI [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

    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


  • QMAX Median at Baseline and 12 Months With CI 95% [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: April 2013
Estimated Study Completion Date: September 2018
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UroLift® System
Single-arm of qualified subjects receiving UroLift® System intervention.
Device: UroLift® System
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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Size, volume,length of prostate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876706

Locations
United States, California
Genesis Research LLC
San Diego, California, United States, 92123
United States, Florida
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
Pinellas Urology
St. Petersburg, Florida, United States, 33710
United States, Maryland
Chesapeake Urology
Baltimore, Maryland, United States, 21237
United States, Nevada
Sheldon J. Freedman, M.D., Ltd.
Las Vegas, Nevada, United States, 89144
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
NeoTract, Inc.
Investigators
Principal Investigator: Neal D Shore, MD Grand Strand Urology
  More Information

Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01876706     History of Changes
Other Study ID Numbers: CP12911 
Study First Received: May 6, 2013
Results First Received: April 29, 2015
Last Updated: March 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by NeoTract, Inc.:
UroLift System

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 30, 2016