Status:
UNKNOWN
Mirabegron And Ureteral Stent-related Pain (MAP) Trial
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Urological Association
Conditions:
Nephrolithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 urina...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- First ureteroscopic treatment for the ureteric or renal stone
- Retrograde semi-rigid or flexible ureteroscopy
- Placement of a 6Fr, 22-28cm hydrophilic coated ureteric stent
- Follow-up 7 days post operatively at St. Michael's Hospital
- Patient who can read and understand English
Exclusion
- Bilateral ureteral stents
- Stent in situ prior to ureteroscopy
- Pregnancy or breast feeding, or planning on becoming pregnant in the upcoming weeks
- Patients with congenital renal abnormalities (eg: pelvic kidney, ureteric duplication) that may impair proper stent placement
- Patients with urinary diversion or stone in a transplant kidney
- Patients with a history of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (eg: endometriosis), or neurogenic bladder
- Indwelling Foley catheter
- Patients currently taking antimuscarinics, mirabegron, or α-blockers
- Patients with contraindications to receiving mirabegron (ie: urinary retention, end-stage renal disease, uncontrolled hypertension, known QT prolongation)
- Significant cognitive impairment
- Patients with contraindications to opioid use (hypersensitivity, MAO inhibitor use within 14 days, severe respiratory depression, acute or severe asthma, GI obstruction, paralytic ileus, GI stricture)
- Suspected or confirmed ureteral perforation
- Stent placement without tether
- Untreated urinary tract infection
- Antegrade ureteroscopy
- Opioid addiction
- Plan for stent removal at another centre other than St. Michael's Hospital
- Moderate to severe cardiovascular disease and cerebrovascular disease
- Signs of hepatic dysfunction including significant liver function test elevation
- Patients who cannot read and understand English
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04286152
Start Date
February 3 2020
End Date
June 30 2021
Last Update
February 26 2020
Active Locations (1)
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1
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada, M5B1W8