Trial · NCT02744430
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
NCT02744430, Phase 2, Completed, Baylor College of Medicine; results first posted 2022-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain. Trials, record NCT02744430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02744430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
- NCT number
- NCT02744430
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Ureteral Obstruction, Flank Pain
- Interventions
- Mirabegron, Placebo
- First posted
- 2016-04-20
- Last updated
- 2022-04-26
- Results first posted
- 2022-04-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Spontaneous Stone Passage Using Fisher's Exact Test | 30 days | 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. |
| Secondary | Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale | 2 months | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Spontaneous Stone Passage Using Fisher's Exact Test | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale | 2 months | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Spontaneous Stone Passage Using Fisher's Exact Test | Arm 1 - Active | 8 | Participants | ||
| Spontaneous Stone Passage Using Fisher's Exact Test | Arm 2 - Placebo | 5 | Participants | ||
| Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale | Arm 1 - Active | 0.21 | Full Range 0 to 10 | units on a scale | |
| Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale | Arm 2 - Placebo | 0.19 | Full Range 0 to 10 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 - Active | 17 | |
| Overall Study | STARTED | Arm 2 - Placebo | 16 | |
| Overall Study | COMPLETED | Arm 1 - Active | 17 | |
| Overall Study | COMPLETED | Arm 2 - Placebo | 16 | |
| Overall Study | NOT COMPLETED | Arm 1 - Active | 0 | |
| Overall Study | NOT COMPLETED | Arm 2 - Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 2 - Placebo | 0 | 16 |
| Total, all-cause mortality | Arm 1 - Active | 0 | 17 |
| Total, other adverse events | Arm 2 - Placebo | 0 | 16 |
| Total, other adverse events | Arm 1 - Active | 0 | 17 |
| Total, serious adverse events | Arm 2 - Placebo | 0 | 16 |
| Total, serious adverse events | Arm 1 - Active | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1 - Active vs Arm 2 - Placebo: Spontaneous Stone Passage Using Fisher's Exact Test | Trial comparisons |
| Arm 1 - Active vs Arm 2 - Placebo: deaths from any cause | Trial comparisons |
| Arm 1 - Active vs Arm 2 - Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02744430
GET https://conductscience.org/api/trials/v1/NCT02744430/registered