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

Nephrolithiasis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nephrolithiasis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Mirabegron50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days

Drug:Tamsulosin0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days

Drug:Tylenol #31 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Narcotic analegesic onlyDrug: Tylenol #3 1 tablet every six hours as necessary

Mirabegron and narcotic analgesiaDrug : Mirabegron 50 mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

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

Mirabegron, Tamsulosin and narcoticDrug: Mirabegron 50 mg oral daily Drug: Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

Study Status

Recruiting

Start Date: November 2014

Completed Date: August 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.

Secondary Outcome: Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.

Study sponsors, principal investigator, and references

Principal Investigator: Andrea G Lantz, MD

Lead Sponsor: Nova Scotia Health Authority

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02095665

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