Mirabegron And Ureteral Stent-related Pain (MAP) Trial

Unity Health Toronto

Status and phase: Unknown; Phase 3

Conditions: Nephrolithiasis

Treatments: Drug: Mirabegron 50 MG; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04286152

19-086

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

142 participants in 2 patient groups, including a placebo group

Mirabegron and narcotic analgesia

Experimental group

Description:

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

Treatment:

Drug: Mirabegron 50 MG

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet