Trial Outcomes & Findings for Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain (NCT NCT02744430)
NCT ID: NCT02744430
Last Updated: 2022-04-26
Results Overview
The primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
30 days
Results posted on
2022-04-26
Participant Flow
33 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Arm 1 - Active
Mirabegron 50 mg orally once every 24 hours starting immediately
Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
Arm 2 - Placebo
Placebo orally once every 24 hours starting immediately
Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
Baseline characteristics by cohort
| Measure |
Arm 1 - Active
n=17 Participants
Mirabegron 50 mg orally once every 24 hours starting immediately
Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
Arm 2 - Placebo
n=16 Participants
Placebo orally once every 24 hours starting immediately
Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
40.45 years
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
CBC WBC
|
10.7 10^9 cells/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
11.1 10^9 cells/L
STANDARD_DEVIATION 2.6 • n=7 Participants
|
10.9 10^9 cells/L
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
CBC Hgb
|
10.7 grams/dL
STANDARD_DEVIATION 2.5 • n=5 Participants
|
11.1 grams/dL
STANDARD_DEVIATION 2.6 • n=7 Participants
|
10.9 grams/dL
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
CBC Platelets
|
15.1 "10^10 platelets per liter
STANDARD_DEVIATION 1.6 • n=5 Participants
|
13.6 "10^10 platelets per liter
STANDARD_DEVIATION 1.3 • n=7 Participants
|
14.35 "10^10 platelets per liter
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
BMP Creatinine
|
1 mg/dl
STANDARD_DEVIATION 0.2 • n=5 Participants
|
.9 mg/dl
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.95 mg/dl
STANDARD_DEVIATION .4 • n=5 Participants
|
|
BMP Potassium
|
4 mmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
3.8 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
|
3.9 mmol/L
STANDARD_DEVIATION .8 • n=5 Participants
|
|
BMP Calcium
|
1.1 mmol/L
STANDARD_DEVIATION .1 • n=5 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.15 mmol/L
STANDARD_DEVIATION .2 • n=5 Participants
|
|
Stone Size
|
5.5 mm
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.4 mm
STANDARD_DEVIATION 1.6 • n=7 Participants
|
5.45 mm
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
UA RBC
|
20 RBC/HPF
STANDARD_DEVIATION 4.0 • n=5 Participants
|
19 RBC/HPF
STANDARD_DEVIATION 5.0 • n=7 Participants
|
19.5 RBC/HPF
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Previous Stone
Yes
|
6 count of participants
n=5 Participants
|
11 count of participants
n=7 Participants
|
8.5 count of participants
n=5 Participants
|
|
Previous Stone
No
|
11 count of participants
n=5 Participants
|
5 count of participants
n=7 Participants
|
8 count of participants
n=5 Participants
|
|
Stone Location
Upper
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Stone Location
Lower
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device.
Outcome measures
| Measure |
Arm 1 - Active
n=17 Participants
Mirabegron 50 mg orally once every 24 hours starting immediately
Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
Arm 2 - Placebo
n=16 Participants
Placebo orally once every 24 hours starting immediately
Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
|---|---|---|
|
Spontaneous Stone Passage Using Fisher's Exact Test
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Comparisons between arms were calculated with ttest, Wilcoxon rank sum, and Fisher's exact test. Regression assessed odds of stone passageby 30 day visit by treatment arm. Time-to-stone pass was analyzed using Kaplan-Meier curves, log rank test,Cox proportional hazards regression. Patients who didn't pass stone were censored at last follow-up date. Wong-Baker Pain Rating Scale has zero to ten range. Zero represents no pain and ten represents worst.
Pain measures between treatment groups will be measured daily for each patient by using the Wong-Baker Pain Rating Scale. The Questionnaire will be observed in patients who require surgical intervention, and will be observed during study visit. A general linear model will be used to compare Wong-Baker pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group.
Outcome measures
| Measure |
Arm 1 - Active
n=17 Participants
Mirabegron 50 mg orally once every 24 hours starting immediately
Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
Arm 2 - Placebo
n=16 Participants
Placebo orally once every 24 hours starting immediately
Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus \>5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
|
|---|---|---|
|
Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale
|
0.21 units on a scale
Interval 0.0 to 10.0
|
0.19 units on a scale
Interval 0.0 to 10.0
|
Adverse Events
Arm 2 - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 1 - Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place