Tamsulosin versus solifenacin versus mirabegron to ease ureteral stent symptoms
A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
This study will test whether tamsulosin, solifenacin, or mirabegron help adults with ureteral stents after stone surgery have less pain and urinary discomfort.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Bir Hospital Government |
| Locations | 1 site (Kathmandu, Bagmati) |
| Trial ID | NCT06803030 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 3 trial enrolls adults aged 19–80 who receive a unilateral ureteric stent after rigid ureteroscopy or retrograde intrarenal surgery and assigns them to tamsulosin 0.4 mg, solifenacin 5 mg, or mirabegron 25 mg. Symptom burden is measured using the validated Ureteral Stent Symptom Questionnaire (USSQ) on days 1, 7, and 14 after stent placement. Key exclusions include concurrent use of alpha-blockers or anticholinergics, neurogenic bladder or OAB, active febrile UTI, single kidney, recent major pelvic or bladder surgery, pregnancy/breastfeeding, and significant cardiac or hepatic disease. The trial compares USSQ scores across the three medication arms to determine which drug provides the most symptom relief.
Who should consider this trial
Good fit: Adults aged 19–80 who undergo unilateral rigid ureteroscopy or RIRS with planned ureteric stent insertion and who are not taking excluded medications or having excluded medical conditions are ideal candidates.
Not a fit: Patients with neurogenic bladder or OAB, a single kidney, active febrile UTI, pregnancy or breastfeeding, major cardiac/hepatic disease, recent pelvic/bladder/prostate surgery, or those undergoing percutaneous or open ureteric surgery are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, one of these medications could meaningfully reduce pain and urinary bother from ureteral stents, improving recovery and quality of life after stone surgery.
How similar studies have performed: Previous randomized studies and meta-analyses have shown modest benefit from alpha-blockers and antimuscarinics for stent-related symptoms, while mirabegron has been less extensively studied for this indication.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score * Allergy to any medication
Where this trial is running
Kathmandu, Bagmati
- NAMS, Bir Hospital — Kathmandu, Bagmati, Nepal (Recruiting)
Study contacts
- Study coordinator: Baikuntha Adhikari, MCh
- Email: baikadhe@gmail.com
- Phone: +977 9849896780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.