Benign Prostatic Hyperplasia
Conditions
Keywords
UroLift System
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.
Interventions
DEVICEUroLift® 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.
Sponsors
NeoTract, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion criteria
* Size, volume,length of prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| BPH 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. |
| BPH 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. |
| 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. |
| 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 symptomatic |
| 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 |
| 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. |
| 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 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 symptomatic |
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UroLift Arm Subjects that undergo the UroLift System procedure | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | BPH Intervention | 9 |
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawals | 6 |
Baseline characteristics
| Characteristic | UroLift Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 65.5 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 51 |
| other Total, other adverse events | 47 / 51 |
| serious Total, serious adverse events | 12 / 51 |
Outcome results
Primary
Quality of Recovery
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.
Time frame: 1 Month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UroLift Arm | Quality of Recovery | 90 - 100 Score | 28 participants |
| UroLift Arm | Quality of Recovery | 80 - 89 Score | 16 participants |
Secondary
BPH II 12 Month Change From Baseline
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift Arm | BPH II 12 Month Change From Baseline | 4.61 BPHII total score | Standard Deviation 3.23 |
Secondary
BPH II 12 Month Percent (%) Change From Baseline
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift Arm | BPH II 12 Month Percent (%) Change From Baseline | 71.7 percentage change |
Secondary
BPHII Baseline and 12 Month Median Score, 95% CI
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.
Time frame: 12 Month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| UroLift Arm | BPHII Baseline and 12 Month Median Score, 95% CI | Baseline BPHII | 7.00 BPHII total score |
| UroLift Arm | BPHII Baseline and 12 Month Median Score, 95% CI | 12 Month BPHII | 1.00 BPHII total score |
Secondary
BPH II Scores at Baseline and 12 Month Follow-up
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.
Time frame: 12 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift Arm | BPH II Scores at Baseline and 12 Month Follow-up | Baseline BPHII | 6.32 BPHII total score | Standard Deviation 3.04 |
| UroLift Arm | BPH II Scores at Baseline and 12 Month Follow-up | 12 Month BPHII | 1.71 BPHII total score | Standard Deviation 2.3 |
Secondary
IPSS 12 Month Change From Baseline
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift Arm | IPSS 12 Month Change From Baseline | 11.05 scores on a scale | Standard Deviation 7.15 |
Secondary
IPSS 12 Month Percent (%) Change From Baseline
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift Arm | IPSS 12 Month Percent (%) Change From Baseline | 53.5 percentage change |
Secondary
IPSS at Baseline and 12 Months, Median , 95% CI
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
Time frame: 12 Month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| UroLift Arm | IPSS at Baseline and 12 Months, Median , 95% CI | Baseline IPSS score | 20.0 IPSS total score |
| UroLift Arm | IPSS at Baseline and 12 Months, Median , 95% CI | 12 Month IPSS score | 8.00 IPSS total score |
Secondary
IPSS Scores at Baseline and 12 Month Follow-up
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
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift Arm | IPSS Scores at Baseline and 12 Month Follow-up | 12 Month IPSS | 9.73 IPSS total score | Standard Deviation 7.45 |
| UroLift Arm | IPSS Scores at Baseline and 12 Month Follow-up | Baseline IPSS | 20.78 IPSS total score | Standard Deviation 5.28 |
Secondary
Pain Tolerability Throughout the UroLift System Procedure
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.
Time frame: 12 Month
Population: Pain Tolerability throughout the UroLift System Procedure
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| UroLift Arm | Pain Tolerability Throughout the UroLift System Procedure | After sheath removed (end of procedure) | 3.4 units on a scale |
| UroLift Arm | Pain Tolerability Throughout the UroLift System Procedure | During Flexible cystoscopy | 3.0 units on a scale |
| UroLift Arm | Pain Tolerability Throughout the UroLift System Procedure | After Rigid cystoscopy | 4.8 units on a scale |
| UroLift Arm | Pain Tolerability Throughout the UroLift System Procedure | During UroLift implant placement | 5.0 units on a scale |
Secondary
QMAX 12 Month Change Minus Baseline
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
Time frame: 12 Months
Population: QMAX maximum peak urinary flow rate, if valid void \>125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift Arm | QMAX 12 Month Change Minus Baseline | 3.45 mL/sec | Standard Deviation 4.58 |
Secondary
QMAX 12 Month Percent (%) Change in mL/Sec From Baseline
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
Time frame: 12 Months
Population: QMAX maximum peak urinary flow rate, if valid void \>125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift Arm | QMAX 12 Month Percent (%) Change in mL/Sec From Baseline | 57.4 percentage change |
Secondary
QMAX Median at Baseline and 12 Months With CI 95%
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.
Time frame: 12 Month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| UroLift Arm | QMAX Median at Baseline and 12 Months With CI 95% | Baseline | 9.00 mL/sec |
| UroLift Arm | QMAX Median at Baseline and 12 Months With CI 95% | 12 Month | 12.0 mL/sec |
Secondary
Qmax Scores at Baseline and 12 Month Follow-up
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.
Time frame: 12 Month
Population: QMAX maximum peak urinary flow rate, if valid void \>125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift Arm | Qmax Scores at Baseline and 12 Month Follow-up | Baseline Qmax | 8.33 mL/sec | Standard Deviation 2.07 |
| UroLift Arm | Qmax Scores at Baseline and 12 Month Follow-up | 12 Month Qmax | 11.79 mL/sec | Standard Deviation 4.5 |