MedTrace Logo

Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

NCT02095665 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-11-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Andrea G Lantz, MD · Staff Urologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2018-03-23
Completion
2018-03-23

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095665 on ClinicalTrials.gov