Tamsulosin versus solifenacin versus mirabegron to ease ureteral stent symptoms
Official title: A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
Run by Bir Hospital · NCT06803030 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 189 (estimated) |
| Sponsor | Bir Hospital Government |
| Locations | 1 site (Kathmandu, Bagmati) |
| Status | Recruiting |
| Started | August 30, 2025 |
| Main results expected | December 1, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT06803030 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
NAMS, Bir Hospital
Kathmandu, Bagmati, Nepal Recruiting
Study contacts
- Study coordinator: Baikuntha Adhikari, MCh
- Email: baikadhe@gmail.com
- Phone: +977 9849896780
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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High-dose dexamethasone to relieve ureteral stent symptoms after kidney stone procedure
In people undergoing ureteroscopy with a ureteral stent, the study tests whether a 20 mg dose of dexamethasone helps reduce urinary symptoms and pain more than a 4 mg dose.
-
Comparing Two Ureteral Stent Designs in Children with Kidney Stones
This study tests whether two common ureteral stents lead to different comfort and urinary symptoms in kids undergoing stone treatment.
-
ComfiJ vs. standard double-J stent after ureteroscopy or RIRS
This trial tests whether a ComfiJ ureteral stent causes fewer urinary symptoms than a conventional double-J stent in adults needing short-term stenting after ureteroscopy or RIRS for stones.
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Melatonin and Solifenacin for stent-related symptoms after ureteroscopy
This study tests whether solifenacin, melatonin, or both can reduce stent-related urinary symptoms and improve sleep after ureteroscopic stone treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.