Trial · NCT04286152
Mirabegron And Ureteral Stent-related Pain (MAP) Trial
NCT04286152, Phase 3, Unknown, Unity Health Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirabegron And Ureteral Stent-related Pain (MAP) Trial. Trials, record NCT04286152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04286152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirabegron And Ureteral Stent-related Pain (MAP) Trial
- NCT number
- NCT04286152
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 142 participants, estimated
- Lead sponsor
- Unity Health Toronto
- Conditions
- Nephrolithiasis
- Interventions
- Mirabegron 50 MG, Placebo oral tablet
- First posted
- 2020-02-26
- Last updated
- 2020-02-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary outcome of this trial is to assess ureteral stent pain related using a visual analog scale (VAS) and the cumulative score of the 8 pain questions from the Ureteral Stent Symptom Questionnaire (USSQ). | 7 days | The primary objective of the study is to determine if Mirabegron is effective in decreasing ureteral stent related pain following ureteroscopy when compared to placebo. The visual analog scale (VAS) is a validated, subjective method for measuring pain. The patient makes daily a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain") based on his/her perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point marked by the patient. Pain will also be measured utilizing the "Body Pain" section (questions P1-P9) from the Ureteral Stent Symptoms Questionnaire (USSQ). This is a self-administered questionnaire for patients to report their symptoms for comparison, enabling the comparison between the two treatment arms. Higher scores are associated with greater intensity of symptoms reported. |
| Secondary | Opioid consumption | 7 days | This secondary objective is to determine if Mirabegron is effective in decreasing the opioid consumption in order to tolerate stent pain related. The total opioid consumption will be calculated by counting the number of Hydromorphone tablets used per patient plus the opioid equivalence for the Tylenol ES tablets used. |
| Secondary | Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ. | 7 days | This secondary objective is to determine if Mirabegron is effective in improving the urinary symptom score utilizing the Ureteral Stent Symptom Questionnaire - USSQ questions U1-U11 from the USSQ. This is a self-administered questionnaire for patients to report their symptoms for comparison, enabling the comparison between the two treatment arms. Higher scores are associated with greater intensity of symptoms reported. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.) |
| Secondary | General health score (questions G1-G6 from the Ureteral Stent Symptom Questionnaire - USSQ) | 7 days | This secondary objective is to determine if Mirabegron is effective in improving the general health score utilizing the Ureteral Stent Symptom Questionnaire - questions G1-G6 from the USSQ. This is a self-administered questionnaire for patients to report their symptoms for comparison, enabling the comparison between the two treatment arms. Higher scores are associated with greater intensity of symptoms reported. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.) |
| Secondary | Work performance score (questions W1-W7 from the Ureteral Stent Symptom Questionnaire - USSQ) | 7 days | This secondary objective is to determine if Mirabegron is effective in improving the Work performance score utilizing the Ureteral Stent Symptom Questionnaire - USSQ questions W1-W7 from the USSQ. This is a self-administered questionnaire for patients to report their symptoms for comparison, enabling the comparison between the two treatment arms. Higher scores are associated with greater intensity of symptoms reported. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04286152
GET https://conductscience.org/api/trials/v1/NCT04286152/registered