Trial Outcomes & Findings for Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement (NCT NCT02462837)
NCT ID: NCT02462837
Last Updated: 2023-06-13
Results Overview
Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (\>16).
TERMINATED
PHASE2
11 participants
2 weeks
2023-06-13
Participant Flow
We consented 11 patients. Two were screen fails (SF) after consenting but prior to randomization. Two patients were early withdrawls (EW) prior to enrollment when their surgeries were moved to a non-study hospital. Of the 11 total consented, 4 dropped out resulting in a total of 7 being assigned to a treatment arm. One of the SF patients provided baseline quesionnaire date (which has been updated), the other SF and both EW did not provide any baseline information.
Participant milestones
| Measure |
Treatment Arm
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Treatment Arm
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Overall Study
pt developed hives
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
of the 4 patients in the treatment arm - 2 of them did not finish the study after a couple of days of enrollment due 1)hives) and 2) desire to no longer be a participant in the study. The two who did not finish the study did complete the baseline questionnaire.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=4 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
|
American Urological Association Symptom Score (AUASS)
|
18.75 units on a scale
n=4 Participants • of the 4 patients in the treatment arm - 2 of them did not finish the study after a couple of days of enrollment due 1)hives) and 2) desire to no longer be a participant in the study. The two who did not finish the study did complete the baseline questionnaire.
|
8.67 units on a scale
n=3 Participants • of the 4 patients in the treatment arm - 2 of them did not finish the study after a couple of days of enrollment due 1)hives) and 2) desire to no longer be a participant in the study. The two who did not finish the study did complete the baseline questionnaire.
|
14.42 units on a scale
n=7 Participants • of the 4 patients in the treatment arm - 2 of them did not finish the study after a couple of days of enrollment due 1)hives) and 2) desire to no longer be a participant in the study. The two who did not finish the study did complete the baseline questionnaire.
|
|
Patient Global Impression of Severity (PGI-S) Questionnaire
|
3 units on a scale
n=4 Participants • Data provided is only for 6 patients, as 1/7 patient did not finish this questionnaire at baseline
|
2 units on a scale
n=2 Participants • Data provided is only for 6 patients, as 1/7 patient did not finish this questionnaire at baseline
|
2.67 units on a scale
n=6 Participants • Data provided is only for 6 patients, as 1/7 patient did not finish this questionnaire at baseline
|
|
Visual Analog Scale (VAS)
|
4 units on a scale
n=4 Participants
|
0.67 units on a scale
n=3 Participants
|
2.57 units on a scale
n=7 Participants
|
|
Incontinence Symptom Severity Index (ISSI)
|
13 units on a scale
n=4 Participants
|
4.67 units on a scale
n=3 Participants
|
9.43 units on a scale
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were assigned to treatment/placebo arms and two of them (both in treatment) withdrew after the first dose. Therefore, we are only left with 5 patients completing the study.
Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (\>16).
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
|
9.5 score on a scale
Interval 4.0 to 15.0
|
8 score on a scale
Interval 6.0 to 11.0
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were assigned to treatment/placebo arms and two of them (both in treatment) withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Patients did not provide baseline micturitions so cannot do analysis of improvemet of baseline to 2 week f/u.
Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 2 weeks cannot be analyzed from baseline
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were assigned to treatment/placebo arms and two of them (both in treatment) withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Patient did not provide baseline number of incidence so cannot do analysis of improvement of baseline to 2 week follow-up.
Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 2 weeks cannot be analyzed from baseline.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 weekPopulation: Study was terminated due to insufficient rate of accrual. Therefore, we are only left with 5 patients completing the study.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (\>16). .
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
|
10 score on a scale
Interval 3.0 to 17.0
|
6.67 score on a scale
Interval 4.0 to 9.0
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Patients did not provide baseline micturitions so cannot do analysis of improvemet of baseline to 1 week f/u.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 1 week cannot be analyzed from baseline
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 weekPopulation: Study was terminated due to insufficient rate of accrual. Patient did not provide baseline number of incidence so cannot do analysis of improvement of baseline to 1 week follow-up.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 1 week cannot be analyzed from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week, 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were assigned to treatment/placebo arms and two of them (both in treatment) withdrew after the first dose. Therefore, we are only left with 5 patients completing the study.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Visual analog scale is from 1-10 (10 being the worse possible pain).
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.
2 week follow/up
|
4.5 score on a scale
Interval 2.0 to 7.0
|
1.33 score on a scale
Interval 0.0 to 4.0
|
|
Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.
1 week follow/up
|
4 score on a scale
Interval 0.0 to 8.0
|
2.67 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were enrolled and two of them withdrew after the fist dose. Therefore, we are only left with 5 patients completing the study.
Only seven patients were enrolled and two of them withdrew after the fist dose. Therefore, we are only left with 5 patients completing the study. PGI-S is a four item questionnaire asking for patient enumeration of their urinary symptoms when compared to symptoms prior to surgery (1= normal, 2=mild, 3=moderate, 4=severe)
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.
|
2.5 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, 5 patients completed study. We are including the two early withdrawal patients in this population analysis because they did provide the pain medication log prior to withdrawal.
This outcome measure will be listed in 1) mean number of days that pain medications were taken
Outcome measures
| Measure |
Treatment Arm
n=4 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Reduction in Pain Medicine Intake at the 2 Week Follow-up
|
5 days
Interval 1.0 to 11.0
|
7.67 days
Interval 3.0 to 15.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Study was terminated due to insufficient rate of accrual. Only seven patients were enrolled and two of them withdrew after the first dose. There 5 patients completed study. We are including the two early withdrawal patients because they did provide the pain medication log prior to withdrawal.
This outcome measure will be listed in mean number of times per day that pain medication was taken
Outcome measures
| Measure |
Treatment Arm
n=4 Participants
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 Participants
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Reduction in Pain Medicine Intake at the 2 Week Follow-up
|
2.22 # times per day pain medication taken
Interval 1.0 to 5.0
|
1.4 # times per day pain medication taken
Interval 1.0 to 2.0
|
Adverse Events
Treatment Arm
Placebo Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=4 participants at risk
after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks
Mirabegron
|
Placebo Arm
n=3 participants at risk
after stent placement, patient will be given placebo PO, once daily, for 2 weeks
Placebo
|
|---|---|---|
|
Renal and urinary disorders
hematuria
|
0.00%
0/4 • up to 6 weeks
it does not differ from the clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • up to 6 weeks
it does not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • up to 6 weeks
it does not differ from the clinicaltrials.gov definitions
|
0.00%
0/3 • up to 6 weeks
it does not differ from the clinicaltrials.gov definitions
|
Additional Information
Dr. Danuta Dynda
Southern Illinois University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place