Recruiting
Phase 3

Mirabegron & Ureteral Stent

Sponsor:

Unity Health Toronto

Code:

NCT04286152

Conditions

Nephrolithiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mirabegron 50 MG

Placebo oral tablet

Study Details

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 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

Study ID

NCT04286152

Start date

Feb 3, 2020

Status verified date

Feb, 2020

Completion date

Jun 30, 2021

Anticipated

Primary completion date

Feb 28, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 18 years old
2. First ureteroscopic treatment for the ureteric or renal stone
3. Retrograde semi-rigid or flexible ureteroscopy
4. Placement of a 6Fr, 22-28cm hydrophilic coated ureteric stent
5. Follow-up 7 days post operatively at St. Michael's Hospital
6. Patient who can read and understand English

Exclusion Criteria:

1. Bilateral ureteral stents
2. Stent in situ prior to ureteroscopy
3. Pregnancy or breast feeding, or planning on becoming pregnant in the upcoming weeks
4. Patients with congenital renal abnormalities (eg: pelvic kidney, ureteric duplication) that may impair proper stent placement
5. Patients with urinary diversion or stone in a transplant kidney
6. Patients with a history of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (eg: endometriosis), or neurogenic bladder
7. Indwelling Foley catheter
8. Patients currently taking antimuscarinics, mirabegron, or α-blockers
9. Patients with contraindications to receiving mirabegron (ie: urinary retention, end-stage renal disease, uncontrolled hypertension, known QT prolongation)
10. Significant cognitive impairment
11. 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)
12. Suspected or confirmed ureteral perforation
13. Stent placement without tether
14. Untreated urinary tract infection
15. Antegrade ureteroscopy
16. Opioid addiction
17. Plan for stent removal at another centre other than St. Michael's Hospital
18. Moderate to severe cardiovascular disease and cerebrovascular disease
19. Signs of hepatic dysfunction including significant liver function test elevation
20. Patients who cannot read and understand English

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mirabegron and narcotic analgesia

Drug: Mirabegron 50mg tablet, oral, daily from stent insertion until removal - 7days Drug: Hydromorphone 1mg tablet oral, every 4 hours as necessary Drug: Tylenol ES 500mg tablet , oral, every 6 hours as necessary

placebo comparator: Placebo

Drug: Placebo for Mirabegron, 1 tablet, oral, daily from stent insertion until removal - 7days Drug:Hydromorphone 1mg tablet oral, every 4 hours as necessary Drug: Tylenol ES 500mg tablet , oral, every 6 hours as necessary

Interventions

Mirabegron 50 MG

The experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal

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

Primary outcome measure

  • The primary outcome of this trial is to assess ureteral stent pain related using a visual analog scale (VAS) and the cumulative score of the 8 pain questions from the Ureteral Stent Symptom Questionnaire (USSQ). [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Daniela Ghiculete, MD, MSc

416-864-6060Daniela.Ghiculete@unityhealth.to

Michael Ordon, MD, FRCS

416-867-3705Michael.Ordon@unityhealth.to

Locations

St. Michael's Hospital, Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Daniela Ghiculete, MD, MSc

416-864-6060Daniela.Ghiculete@unityhealth.to

Michael Ordon, MD, FRCSC

416-867-3705Michael.Ordon@unityhealth.to

Principal Investigator:

Michael Ordon, MD, FRCSC

More Information

Sponsor

Unity Health Toronto

Last update posted

Feb 26, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2020-02-26.