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Mirabegron And Ureteral Stent-related Pain (MAP) Trial (MAP)

Primary Purpose

Nephrolithiasis

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Mirabegron 50 MG
Placebo oral tablet
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Michael's Hospital, Unity Health TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirabegron and narcotic analgesia

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Opioid consumption
This secondary objective is to determine if Mirabegron is effective in decreasing the opioid consumption in order to tolerate stent pain related. The total opioid consumption will be calculated by counting the number of Hydromorphone tablets used per patient plus the opioid equivalence for the Tylenol ES tablets used.
Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ.
This secondary objective is to determine if Mirabegron is effective in improving the urinary symptom score utilizing the Ureteral Stent Symptom Questionnaire - USSQ questions U1-U11 from the 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. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.)
General health score (questions G1-G6 from the Ureteral Stent Symptom Questionnaire - USSQ)
This secondary objective is to determine if Mirabegron is effective in improving the general health score utilizing the Ureteral Stent Symptom Questionnaire - questions G1-G6 from the 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. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.)
Work performance score (questions W1-W7 from the Ureteral Stent Symptom Questionnaire - USSQ)
This secondary objective is to determine if Mirabegron is effective in improving the Work performance score utilizing the Ureteral Stent Symptom Questionnaire - USSQ questions W1-W7 from the 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. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.)

Full Information

First Posted
February 19, 2020
Last Updated
February 24, 2020
Sponsor
Unity Health Toronto
Collaborators
Canadian Urological Association
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1. Study Identification

Unique Protocol Identification Number
NCT04286152
Brief Title
Mirabegron And Ureteral Stent-related Pain (MAP) Trial
Acronym
MAP
Official Title
Mirabegron And Ureteral Stent-related Pain (MAP) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Urological Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized, placebo-controlled, double blinded trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirabegron and narcotic analgesia
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Mirabegron 50 MG
Other Intervention Name(s)
Myrbertiq
Intervention Description
The experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
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
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
This secondary objective is to determine if Mirabegron is effective in decreasing the opioid consumption in order to tolerate stent pain related. The total opioid consumption will be calculated by counting the number of Hydromorphone tablets used per patient plus the opioid equivalence for the Tylenol ES tablets used.
Time Frame
7 days
Title
Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ.
Description
This secondary objective is to determine if Mirabegron is effective in improving the urinary symptom score utilizing the Ureteral Stent Symptom Questionnaire - USSQ questions U1-U11 from the 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. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.)
Time Frame
7 days
Title
General health score (questions G1-G6 from the Ureteral Stent Symptom Questionnaire - USSQ)
Description
This secondary objective is to determine if Mirabegron is effective in improving the general health score utilizing the Ureteral Stent Symptom Questionnaire - questions G1-G6 from the 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. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.)
Time Frame
7 days
Title
Work performance score (questions W1-W7 from the Ureteral Stent Symptom Questionnaire - USSQ)
Description
This secondary objective is to determine if Mirabegron is effective in improving the Work performance score utilizing the Ureteral Stent Symptom Questionnaire - USSQ questions W1-W7 from the 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. (Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occurring 7days later.)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 Opioid addiction Plan for stent removal at another centre other than St. Michael's Hospital Moderate to severe cardiovascular disease and cerebrovascular disease Signs of hepatic dysfunction including significant liver function test elevation Patients who cannot read and understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Ghiculete, MD, MSc
Phone
416-864-6060
Ext
6344
Email
Daniela.Ghiculete@unityhealth.to
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Ordon, MD, FRCS
Phone
416-867-3705
Email
Michael.Ordon@unityhealth.to
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ordon, MD, FRCSC
Organizational Affiliation
St. Michael's Hospital, Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital, Unity Health Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Ghiculete, MD, MSc
Phone
416-864-6060
Ext
6344
Email
Daniela.Ghiculete@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Michael Ordon, MD, FRCSC
Phone
416-867-3705
Email
Michael.Ordon@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Michael Ordon, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Kenneth Pace, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Monica Farcas, MD, FRCSC

12. IPD Sharing Statement

Plan to Share IPD
No

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Mirabegron And Ureteral Stent-related Pain (MAP) Trial

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