Clinical trial NCT02095665: Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
Official title: Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrolithiasis
Keywords: ureteric stents
LUTS
lower urinary tract symptoms
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.
timeFrame: 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 outcomes:
measure: Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.
timeFrame: 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.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, Central
state: Nova Scotia
Study officials:
affiliation: Staff Urologist
name: Andrea G Lantz, MD
role: PRINCIPAL_INVESTIGATOR
References: