Mirabegron And Ureteral Stent-related Pain (MAP) Trial

NCT ID: NCT04286152

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2021-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Mirabegron 50 MG

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

Mirabegron 50 MG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Myrbertiq

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Urological Association

INDUSTRY

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Ordon, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, Unity Health Toronto

Locations

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Daniela Ghiculete, MD, MSc

Role: CONTACT

Daniela.Ghiculete@unityhealth.to

416-864-6060 ext. 6344

Michael Ordon, MD, FRCS

Role: CONTACT

Michael.Ordon@unityhealth.to

416-867-3705

Facility Contacts

Daniela Ghiculete, MD, MSc

Role: primary

Daniela.Ghiculete@unityhealth.to

416-864-6060 ext. 6344

Michael Ordon, MD, FRCSC

Role: backup

Michael.Ordon@unityhealth.to

416-867-3705

Other Identifiers

19-086

Identifier Type: -

Identifier Source: org_study_id