NCT04286152

Mirabegron And Ureteral Stent-related Pain (MAP) Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and/or stone fragments. Up to 75% of patients experience pain following stenting, as well as lower urinary tract symptoms (LUTS) such as finding blood in the urine, voiding often, the need to urinate quickly resulting in a significant source of morbidity. The negative impact of stents results in a significant impact on health related quality of life. There is no standard of care for managing ureteric stent pain and lower urinary tract symptoms following surgery. A combination of α-blockers, antimuscarinics, acetaminophen, nonsteroidal anti-inflammatory drugs and opioids are currently the mainstay for treatment of post-operative pain and LUTS following stenting. Mirabegron is a beta-agonist that mediate relaxation of the detrusor muscle and has been useful in treating overactive bladder (OAB) which has similar symptoms to patients with an ureteric stent in place. Our goal is to assess if mirabegron can improve symptoms and decrease the need for additional pain medications. The investigators hypothesize that Mirabegron is effective in decreasing ureteral stent related LUTS and pain.

Conditions

• Nephrolithiasis

Interventions

Type	Name	Description
DRUG	Mirabegron 50 MG	The experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal
DRUG	Placebo oral tablet	A sugar pill manufactured to mimic Mirabegron 50 mg tablet is administered to patients PO once a day for 7 days from stent insertion until removal

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-02-28
• Completion: 2021-06-30
• First posted: 2020-02-26
• Last updated: 2020-02-26

Locations

1 site across 1 country: Canada