Mirabegron And Ureteral Stent-related Pain (MAP) Trial

NCT04286152 | Unknown Phase 3 DMC

• 1 other identifier: 19-086
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  The primary objective of the study is to determine if Mirabegron is effective in decreasing ureteral stent related pain following ureteroscopy when compared to placebo. The visual analog scale (VAS) is a validated, subjective method for measuring pain. The patient makes daily a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain") based on his/her perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point marked by the patient. Pain will also be measured utilizing the "Body Pain" section (questions P1-P9) from the Ureteral Stent Symptoms Questionnaire (USSQ). This is a self-administered questionnaire for patients to report their symptoms for comparison, enabling the comparison between the two treatment arms. Higher scores are associated with greater intensity of symptoms reported.

  7 days

Secondary Outcomes (4)

• Opioid consumption

  7 days

• Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ.

  7 days

• General health score (questions G1-G6 from the Ureteral Stent Symptom Questionnaire - USSQ)

  7 days

• Work performance score (questions W1-W7 from the Ureteral Stent Symptom Questionnaire - USSQ)

  7 days

Study Arms (2)

Mirabegron and narcotic analgesia

EXPERIMENTAL

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

Drug: Mirabegron 50 MG

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Mirabegron 50 MG DRUG

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

Also known as: Myrbertiq

Mirabegron and narcotic analgesia

Placebo oral tablet 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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Urological Association: collaborator

Study Sites (1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M5B1W8, Canada

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Michael Ordon, MD, FRCSC

  St. Michael's Hospital, Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Ghiculete, MD, MSc

CONTACT

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

Michael Ordon, MD, FRCS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized, placebo-controlled, double blinded trial.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 26, 2020
• Study Start: February 3, 2020
• Primary Completion: February 28, 2021
• Study Completion: June 30, 2021
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)