UroLift System TOlerability and ReCovery When Administering Local Anesthesia
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Device: UroLift® System
- Registration Number
- NCT01876706
- Lead Sponsor
- NeoTract, Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 51
- Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
- Size, volume,length of prostate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description UroLift® System UroLift® System Single-arm of qualified subjects receiving UroLift® System intervention.
- Primary Outcome Measures
Name Time Method Quality of Recovery 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 Outcome Measures
Name Time Method IPSS 12 Month Percent (%) Change From Baseline 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.QMAX 12 Month Change Minus Baseline 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
BPHII Baseline and 12 Month Median Score, 95% CI 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:
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 Scores at Baseline and 12 Month Follow-up 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 symptomaticBPH II 12 Month Percent (%) Change From Baseline 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:
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 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.
QMAX 12 Month Percent (%) Change in mL/Sec From Baseline 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
IPSS 12 Month Change From Baseline 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.BPH II Scores at Baseline and 12 Month Follow-up 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:
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 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 symptomaticBPH II 12 Month Change From Baseline 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:
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.Pain Tolerability Throughout the UroLift System Procedure 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.
QMAX Median at Baseline and 12 Months With CI 95% 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.
Trial Locations
- Locations (7)
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Chesapeake Urology
🇺🇸Baltimore, Maryland, United States
Genesis Research LLC
🇺🇸San Diego, California, United States
Pinellas Urology
🇺🇸Saint Petersburg, Florida, United States
Sheldon J. Freedman, M.D., Ltd.
🇺🇸Las Vegas, Nevada, United States
Advanced Urology Institute
🇺🇸Daytona Beach, Florida, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States