Mirabegron And Ureteral Stent-related Pain (MAP) Trial

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborator: Canadian Urological Association
• Treatments: Mirabegron

Criteria

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