Ureteral Stent-related Pain and Mirabegron (SPAM) Trial (SPAM)

November 4, 2022 updated by: Nova Scotia Health Authority

Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms.

Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic medications. .

The investigators hypothesize that mirabegron is effective in decreasing ureteral stent related LUTS and pain.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Authority, Central

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • First presentation for ureteroscopy for this particular stone
  • Planned insertion of double J ureteral stent
  • Planned ureteral stenting ≥5 days
  • Follow-up conducted at the Queen Elizabeth II Health Sciences Centre

Exclusion Criteria:

  • Bilateral ureteral stents to be inserted
  • Stent already in situ prior to ureteroscopy
  • Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
  • Patients with urinary diversion
  • Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder
  • Indwelling foley catheter
  • Active urinary tract infection
  • Patients currently taking antimuscarinics, mirabegron, or α-blockers
  • Patients with contraindications to receiving either mirabegron or tamsulosin (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection
  • Planned upcoming elective cataract surgery
  • Suspected or confirmed ureteral perforation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Narcotic analegesic only

Drug:

Tylenol #3 1 tablet every six hours as necessary

1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Names:
  • Atasol
ACTIVE_COMPARATOR: Mirabegron and narcotic analgesia

Drug :

Mirabegron 50 mg oral daily

Drug:

Tylenol #3 1 tablet every six hours as necessary

1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Names:
  • Atasol
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
Other Names:
  • Myrbertiq
ACTIVE_COMPARATOR: Tamsulosin and narcotic analgesia

Drug:

Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Names:
  • Atasol
0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days
Other Names:
  • Flomax
EXPERIMENTAL: Mirabegron, Tamsulosin and narcotic

Drug:

Mirabegron 50 mg oral daily

Drug:

Tamsulosin 0.4mg oral daily

Drug:

Tylenol #3 1 tablet every six hours as necessary

1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Names:
  • Atasol
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
Other Names:
  • Myrbertiq
0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days
Other Names:
  • Flomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.
Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed which will occur 5 to 10 days following surgery.
The primary objective of this study is to determine if mirabegron is effective in decreasing ureteral stent related lower urinary tract symptoms (LUTS) following ureteroscopy for urolithiasis when compared to tamsulosin alone and in combination. Utilizing the Ureteral Stent Symptom Questionnaire, a self-administered questionnaire participants will report their urinary symptoms for comparison, enabling the comparison through out the different treatment arms.
Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed which will occur 5 to 10 days following surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.
Time Frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occuring 5 to 10 days later.
The secondary objectives are to determine if mirabegron is effective in decreasing ureteral stent related pain compared to tamsulosin alone and in combination following ureteroscopy for urolithiasis, determining if there are any improvements in health related quality of life (HRQoL). Subjects will maintain a diary recording the frequency of pain medication through out the period the stent remains insitu, 5 to 10 days.
Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occuring 5 to 10 days later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea G Lantz, MD, Staff Urologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

March 23, 2018

Study Completion (ACTUAL)

March 23, 2018

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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