Myrbetriqâ„¢ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement (NCT02462837) | Clinical Trial Compass
TerminatedPhase 2
Myrbetriqâ„¢ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
Stopped: insufficient rate of accrual
United States11 participantsStarted 2015-05
Plain-language summary
The objective of this pilot study is to assess whether Myrbetriqâ„¢ will improve post-operative ureteral pain and discomfort, reduce bladder storage symptoms and increase quality of life following ureteral stenting.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18.
✓. Subject scheduled to undergo a ureteral stent placement for ureteral obstruction or post- ureteroscopy procedure.
✓. Otherwise healthy subjects who are able and willing to participate in the study.
✓. None of the planned interventions are documented in the labeled contraindications, warnings and precautions of the study drug.
Exclusion criteria
✕. Does NOT give consent.
✕. Subject is using prohibited medications which cannot be stopped safely at the screening visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria:
✕. Post void residual volume \> 350 mL.
✕. Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control.
✕. Subject has known neurogenic bladder.
✕. Subject with uncontrolled chronic pain problems or on chronic pain medications.
✕. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test).
✕
What they're measuring
1
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriqâ„¢ Group at the 2 Week Follow-up Compared to Placebo Group.
Timeframe: 2 weeks
2
Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriqâ„¢ Group at the 2 Week Follow-up Compared to Placebo Group.
Timeframe: 2 weeks
3
Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriqâ„¢ Group at the 2 Week Follow-up Compared to Placebo Group.
Timeframe: 2 weeks
4
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriqâ„¢ Group at the 1 Week Follow-up Compared to Placebo Group.
Timeframe: 1 week
5
Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriqâ„¢ Group at the 1 Week Follow-up Compared to Placebo Group.
Timeframe: 1 week
6
Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriqâ„¢ Group at the 1 Week Follow-up Compared to Placebo Group.