Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Nova Scotia Health Authority (NSHA)

Status and phase: Completed; Phase 4

Conditions: Nephrolithiasis

Treatments: Drug: Mirabegron; Drug: Tylenol #3; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT02095665

SPAM

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

22 participants in 4 patient groups

Narcotic analegesic only

Active Comparator group

Description:

Drug: Tylenol #3 1 tablet every six hours as necessary

Treatment:

Drug: Tylenol #3

Mirabegron and narcotic analgesia

Active Comparator group

Description:

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

Treatment:

Drug: Tylenol #3

Drug: Mirabegron

Tamsulosin and narcotic analgesia

Active Comparator group

Description:

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

Treatment:

Drug: Tylenol #3

Drug: Tamsulosin

Mirabegron, Tamsulosin and narcotic

Experimental group

Description:

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

Treatment:

Drug: Tylenol #3

Drug: Tamsulosin

Drug: Mirabegron