Mirabegron And Ureteral Stent-related Pain (MAP) Trial

Nephrolithiasis Clinical Trial

— MAP  

Official title:

Mirabegron And Ureteral Stent-related Pain (MAP) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04286152
• Other study ID #: 19-086
• Status: Recruiting
• Phase: Phase 3
• Start date: February 3, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2020
• Source: St. Michael's Hospital, Toronto
• Contact: Daniela Ghiculete, MD, MSc
• Phone: 416-864-6060
• Email: Daniela.Ghiculete[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: June 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a-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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis

Intervention

Drug:
• Mirabegron 50 MG
The experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal
• 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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital, Unity Health Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Urological Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	7 days
Secondary	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.)	7 days
Secondary	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.)	7 days
Secondary	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.)	7 days