Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Unknown status

CT.gov ID

NCT02095665

Collaborator

(none)

236

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis	Drug: Mirabegron Drug: Tamsulosin Drug: Tylenol #3	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Narcotic analegesic only Drug: Tylenol #3 1 tablet every six hours as necessary	Drug: Tylenol #3 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	Drug: Mirabegron 50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days Other Names: Myrbertiq Drug: Tylenol #3 1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days Other Names: Atasol
Active Comparator: Tamsulosin and narcotic analgesia Drug: Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary	Drug: Tamsulosin 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 Drug: Tylenol #3 1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days Other Names: Atasol
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	Drug: Mirabegron 50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days Other Names: Myrbertiq Drug: Tamsulosin 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 Drug: Tylenol #3 1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days Other Names: Atasol

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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