- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02095665
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial (SPAM)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Nova Scotia Health Authority, Central
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
Other Names:
|
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:
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:
|
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:
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
Other Names:
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:
|
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
Sponsor
Investigators
- Principal Investigator: Andrea G Lantz, MD, Staff Urologist
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Urolithiasis
- Urinary Calculi
- Calculi
- Kidney Calculi
- Nephrolithiasis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Urological Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Adrenergic beta-3 Receptor Agonists
- Acetaminophen
- Tamsulosin
- Mirabegron
Other Study ID Numbers
- SPAM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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