NCT02095665

Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Nova Scotia Health Authority · 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. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms. Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic 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 of Mirabegron daily from stent insertion until removal 5 to 10 days
DRUG	Tamsulosin	0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days
DRUG	Tylenol #3	1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-03-23
• Completion: 2018-03-23
• First posted: 2014-03-26
• Last updated: 2022-11-08

Locations

1 site across 1 country: Canada