Trial Outcomes & Findings for UroLift System TOlerability and ReCovery When Administering Local Anesthesia (NCT NCT01876706)
NCT ID: NCT01876706
Last Updated: 2019-03-20
Results Overview
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.
COMPLETED
NA
51 participants
1 Month
2019-03-20
Participant Flow
Participant milestones
| Measure |
UroLift Arm
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
1 Month
|
51
|
|
Overall Study
3 Months
|
51
|
|
Overall Study
6 Months
|
46
|
|
Overall Study
12 Months
|
42
|
|
Overall Study
24 Months
|
35
|
|
Overall Study
36 Months
|
32
|
|
Overall Study
48 Months
|
31
|
|
Overall Study
60 Months
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
UroLift Arm
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Overall Study
BPH Intervention
|
9
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Withdrawals
|
6
|
|
Overall Study
Death
|
3
|
Baseline Characteristics
UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Baseline characteristics by cohort
| Measure |
UroLift Arm
n=51 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=99 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 MonthPrimary 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.
Outcome measures
| Measure |
UroLift Arm
n=51 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Quality of Recovery
90 - 100 Score
|
28 participants
|
|
Quality of Recovery
80 - 89 Score
|
16 participants
|
SECONDARY outcome
Timeframe: 12 MonthsThe 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
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
IPSS Scores at Baseline and 12 Month Follow-up
Baseline IPSS
|
20.78 IPSS total score
Standard Deviation 5.28
|
|
IPSS Scores at Baseline and 12 Month Follow-up
12 Month IPSS
|
9.73 IPSS total score
Standard Deviation 7.45
|
SECONDARY outcome
Timeframe: 12 MonthsThe 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.
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
IPSS 12 Month Change From Baseline
|
11.05 scores on a scale
Standard Deviation 7.15
|
SECONDARY outcome
Timeframe: 12 MonthsThe 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.
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
IPSS 12 Month Percent (%) Change From Baseline
|
53.5 percentage change
Interval 43.1 to 63.9
|
SECONDARY outcome
Timeframe: 12 MonthBPH 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.
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
BPH II Scores at Baseline and 12 Month Follow-up
Baseline BPHII
|
6.32 BPHII total score
Standard Deviation 3.04
|
|
BPH II Scores at Baseline and 12 Month Follow-up
12 Month BPHII
|
1.71 BPHII total score
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: 12 MonthsBPH 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.
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
BPH II 12 Month Percent (%) Change From Baseline
|
71.7 percentage change
Interval 61.2 to 82.2
|
SECONDARY outcome
Timeframe: 12 MonthsBPH 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.
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
BPH II 12 Month Change From Baseline
|
4.61 BPHII total score
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: 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.
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.
Outcome measures
| Measure |
UroLift Arm
n=33 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Qmax Scores at Baseline and 12 Month Follow-up
Baseline Qmax
|
8.33 mL/sec
Standard Deviation 2.07
|
|
Qmax Scores at Baseline and 12 Month Follow-up
12 Month Qmax
|
11.79 mL/sec
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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
Outcome measures
| Measure |
UroLift Arm
n=33 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
QMAX 12 Month Change Minus Baseline
|
3.45 mL/sec
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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
Outcome measures
| Measure |
UroLift Arm
n=33 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
QMAX 12 Month Percent (%) Change in mL/Sec From Baseline
|
57.4 percentage change
Interval 17.9 to 97.0
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: 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.
Outcome measures
| Measure |
UroLift Arm
n=51 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Pain Tolerability Throughout the UroLift System Procedure
During Flexible cystoscopy
|
3.0 units on a scale
Interval 0.0 to 10.0
|
|
Pain Tolerability Throughout the UroLift System Procedure
After Rigid cystoscopy
|
4.8 units on a scale
Interval 0.0 to 10.0
|
|
Pain Tolerability Throughout the UroLift System Procedure
During UroLift implant placement
|
5.0 units on a scale
Interval 0.0 to 10.0
|
|
Pain Tolerability Throughout the UroLift System Procedure
After sheath removed (end of procedure)
|
3.4 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 12 MonthBPH 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.
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
BPHII Baseline and 12 Month Median Score, 95% CI
Baseline BPHII
|
7.00 BPHII total score
Interval 5.36 to 7.28
|
|
BPHII Baseline and 12 Month Median Score, 95% CI
12 Month BPHII
|
1.00 BPHII total score
Interval 0.98 to 2.43
|
SECONDARY outcome
Timeframe: 12 MonthThe 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
Outcome measures
| Measure |
UroLift Arm
n=41 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
IPSS at Baseline and 12 Months, Median , 95% CI
12 Month IPSS score
|
8.00 IPSS total score
Interval 7.38 to 12.08
|
|
IPSS at Baseline and 12 Months, Median , 95% CI
Baseline IPSS score
|
20.0 IPSS total score
Interval 19.11 to 22.45
|
SECONDARY outcome
Timeframe: 12 MonthQMAX 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.
Outcome measures
| Measure |
UroLift Arm
n=33 Participants
Subjects that undergo the UroLift System procedure
|
|---|---|
|
QMAX Median at Baseline and 12 Months With CI 95%
Baseline
|
9.00 mL/sec
Interval 7.6 to 9.07
|
|
QMAX Median at Baseline and 12 Months With CI 95%
12 Month
|
12.0 mL/sec
Interval 10.19 to 13.38
|
Adverse Events
UroLift Arm
Serious adverse events
| Measure |
UroLift Arm
n=51 participants at risk
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Cardiac disorders
Congestive heart failure
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Lung mass
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Nervous system disorders
Stroke
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.9%
2/51 • Number of events 2 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Cardiac disorders
Myocardial infarction
|
3.9%
2/51 • Number of events 3 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic melanoma
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
2.0%
1/51 • Number of events 1 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
Other adverse events
| Measure |
UroLift Arm
n=51 participants at risk
Subjects that undergo the UroLift System procedure
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
82.4%
42/51 • Number of events 44 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Renal and urinary disorders
Dysuria
|
72.5%
37/51 • Number of events 46 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Reproductive system and breast disorders
Pelvic pain
|
23.5%
12/51 • Number of events 12 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Renal and urinary disorders
Urge Incontinence
|
29.4%
15/51 • Number of events 18 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Renal and urinary disorders
Urinary urgency
|
7.8%
4/51 • Number of events 6 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
3/51 • Number of events 3 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Infections and infestations
Urinary tract infection
|
7.8%
4/51 • Number of events 4 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
3/51 • Number of events 3 • 5 Years;
AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place