NephrolithiasisPhase 3MAPNCT04286152
Mirabegron And Ureteral Stent-related Pain (MAP) Trial
A Phase 3 study testing Mirabegron 50 MG in people with Nephrolithiasis, run by Unity Health Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Mirabegron 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2020to 30 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, M5B1W8
Daniela Ghiculete, MD, MSc, 416-864-6060 ext. 6344, Daniela.Ghiculete@unityhealth.to
Michael Ordon, MD, FRCSC, 416-867-3705, Michael.Ordon@unityhealth.to
About this study
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.
Read more
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
- Being tested
- Mirabegron 50 MG, Placebo oral tablet
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50 MGDrug
Also called Myrbertiq
The experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal
Placebo oral tabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 7 days
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.)
Measured: 7 days
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.)
Measured: 7 days
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.)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start3 Feb 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, placebo-controlled, double blinded trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urological Association
- Responsible party
- Sponsor
- Investigators
- Michael Ordon, MD, FRCSC, Principal investigator, St. Michael's Hospital, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286152
- Sponsor's protocol ID
- 19-086
- Acronym
- MAP
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirabegron And Ureteral Stent-related Pain (MAP) Trial
- ClinicalTrials.gov ID
- NCT04286152
- Acronym / sponsor ID
- MAP / 19-086
- Conditions
- Nephrolithiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Urological Association
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, placebo-controlled, double blinded trial.
| Arm | Type | Receives |
|---|---|---|
| Mirabegron and narcotic analgesia | Experimental | Drug: Mirabegron 50 MGDrug: 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 |
| Placebo | Placebo comparator | Drug: Placebo oral tabletDrug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron 50 MGAlso: MyrbertiqThe experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal | Drug | Mirabegron and narcotic analgesia |
| Placebo oral tabletA 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 | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Opioid consumption
Time frame: 7 days
Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ.
Time frame: 7 days
General health score (questions G1-G6 from the Ureteral Stent Symptom Questionnaire - USSQ)
Time frame: 7 days
Work performance score (questions W1-W7 from the Ureteral Stent Symptom Questionnaire - USSQ)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ordon, MD, FRCSC principal investigator
St. Michael's Hospital, Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirabegron 50 MG in people with Nephrolithiasis, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Ghiculete, MD, MSc (416-864-6060 ext. 6344, Daniela.Ghiculete@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.