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

Phase 3

Not yet recruiting

• Conditions: Ureteral Stent-Related Symptom
• Interventions: Drug: Tamsulosin Hydrochloride 0.4 mg; Drug: Solifenacin Succinate 5 mg; Drug: Mirabegron 25 mg

• Registration Number: NCT06803030
• Lead Sponsor: Bir Hospital

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 Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Study Start: 2025-04-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin group	Tamsulosin Hydrochloride 0.4 mg	placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom
Solifenacin group	Solifenacin Succinate 5 mg	placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom
Mirabegron group	Mirabegron 25 mg	placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom

Primary Outcome Measures

Name	Time	Method
alleviating Ureteral stent related symptoms	2 weeks	mitigating the ureteric stent related symptoms using structured questionnaire

Secondary Outcome Measures

Name	Time	Method
early removal of ureteral stent	before 2 weeks	early removal of stent due to stent migration, fever, urosepsis

Trial Locations

Locations (1)

NAMS, Bir Hospital; 🇳🇵 Kathmandu, Bagmati, Nepal