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Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06803030
Enrollment
189
Registered
2025-01-31
Start date
2025-08-30
Completion date
2026-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stent-Related Symptom

Keywords

Mirabegron, Tamsulosin, Solifenacin

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.

Interventions

placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily

placement of ureteral stents followed by Tab. Solifenacin 5 mg once daily

placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily

Sponsors

Nepal Health Research Council
CollaboratorOTHER_GOV
Bir Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
alleviating Ureteral stent related symptoms2 weeksmitigating the ureteric stent related symptoms using structured questionnaire

Secondary

MeasureTime frameDescription
early removal of ureteral stentbefore 2 weeksearly removal of stent due to stent migration, fever, urosepsis

Countries

Nepal

Contacts

Primary ContactBaikuntha Adhikari, MCh
baikadhe@gmail.com+977 9849896780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026