EVALUATION OF TAMSULOSIN VERSUS MIRABEGRON IN URETERIC STENT RELATED SYMPTOMS- A RANDOMISED CONTROLLED TRIAL
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Josef B Pachikara
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate the effect of Tamsulosin and Mirabegron in ureteral stent related symptoms.
Overview
Brief Summary
Ureteric stents are used often by Urologists followingureteroscopy for prevention of ureteric obstruction from oedema and or stonefragments. They are often associated with pain, need to void often, the need tourinate quickly and finding blood in the urine called "lower urinary tractsymptoms" or LUTS in short. There is randomized studies showing theefficacy of α-blockers such as tamsulosin in relieving"stent symptoms" (pain and LUTS). There is emerging but limitedevidence to show that antimuscarinic medications, used to treat overactivebladder (OAB) have some efficacy in decreasing stent symptoms.
Mirabegron is a beta agonist used to decrease OABsymptoms and has been found to be effective in treating patients with stentrelated symptoms. Mirabegron functions to mediate relaxation of the detrusormuscle. Conventional antimuscarinic medications often have bothersome sideeffects like dry mouth, constipation, blurred vision and cognitive impairment.This may limit their use in some populations. Mirabegron is well-tolerated witha good safety profile and therefore is useful in treating stent symptoms,without the bothersome side effects commonly seen with antimuscarinicmedications. The aim of this study is to compare Tamsulosin and Mirabegron intreating stent related symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who have underwent semirgid ureteroscopy with DJ stenting.
- •Only patients with uncomplicated ureteric calculi.
- •3 Patients aged 18 years to 60 years.
Exclusion Criteria
- •Patients with growth in Urine culture or having symptomatic urinary tract infection.
- •Patients who may need bilateral stent insertion for acute obstruction / obstructive uropathy
- •Male patients with history of prostatic enlargement, prostatitis or prostatic cancer related lower urinary tract symptoms
- •Females with lower urinary tract symptoms related to any form of urinary incontinence, uterine/cervical/vaginal prolapse, or obstruction related to malignancy.
- •History of chronic or recent α-blocker or analgesic drug use were excluded.
- •Pregnancy,
- •Bleeding disorders,
- •Patients with concomitant other lower tract pathology like bladder cancer, bladder outlet obstruction with or without stones, urethral stricture.
- •Patients with simultaneous renal calculus.
- •Patients who underwent open surgery for ureteric calculi previously.
Outcomes
Primary Outcomes
To evaluate the effect of Tamsulosin and Mirabegron in ureteral stent related symptoms.
Time Frame: 2 weeks
Secondary Outcomes
- to assess quality of life in patients taking tamsulosin and mirabegron for ureteral stent related symptoms as measured by USSQ quality of life scale(2 weeks)