A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Bir Hospital
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- alleviating Ureteral stent related symptoms
Overview
Brief Summary
A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.
Detailed Description
Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones
Exclusion Criteria
- •Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- •Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- •Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
- •Preoperative febrile Urinary Tract Infection (UTI)
- •Pregnancy or breastfeeding;
- •A single kidney
- •Moderate or severe cardiovascular or cerebrovascular disease
- •Hepatic dysfunction
- •History of pelvic surgery or irradiation
- •History of bladder or prostate surgery
Arms & Interventions
Tamsulosin group
placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom
Intervention: Tamsulosin Hydrochloride 0.4 mg (Drug)
Solifenacin group
placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom
Intervention: Solifenacin Succinate 5 mg (Drug)
Mirabegron group
placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom
Intervention: Mirabegron 25 mg (Drug)
Outcomes
Primary Outcomes
alleviating Ureteral stent related symptoms
Time Frame: 2 weeks
mitigating the ureteric stent related symptoms using structured questionnaire
Secondary Outcomes
- early removal of ureteral stent(before 2 weeks)
Investigators
Jainendra Kumar Manoj
M Ch Urology Resident
Bir Hospital