Mirabegron And Ureteral Stent-related Pain (MAP) Trial
Overview
- Phase
- Phase 3
- Intervention
- Mirabegron 50 MG
- Conditions
- Nephrolithiasis
- Sponsor
- Unity Health Toronto
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- 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).
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Mirabegron 50 MG
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
Intervention: Placebo oral tablet
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- 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)
- Opioid consumption(7 days)
- Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ.(7 days)