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

A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.

Study Overview

• Status: Recruiting
• Conditions: Ureteral Stent-Related Symptom
• Intervention / Treatment: Drug: Tamsulosin Hydrochloride 0.4 mg; Drug: Solifenacin Succinate 5 mg; Drug: Mirabegron 25 mg

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 Type: Interventional
• Enrollment (Estimated): 189
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Baikuntha Adhikari, MCh; Phone Number: +977 9849896780; Email: baikadhe@gmail.com

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Recruiting
      • NAMS, Bir Hospital
      • Contact: Jainendra K Manoj, Dr; Phone Number: 9841529629; Email: drjkmanoj@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tamsulosin group; placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom	Drug: Tamsulosin Hydrochloride 0.4 mg; placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily; Other Names: Cap. Urimax 0.4 mg
Active Comparator: Solifenacin group; placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom	Drug: Solifenacin Succinate 5 mg; placement of ureteral stents followed by Tab. Solifenacin 5 mg once daily; Other Names: Tab. Solay 5 mg
Active Comparator: Mirabegron group; placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom	Drug: Mirabegron 25 mg; placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily; Other Names: Tab. Mirasin 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
alleviating Ureteral stent related symptoms	mitigating the ureteric stent related symptoms using structured questionnaire	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early removal of ureteral stent	early removal of stent due to stent migration, fever, urosepsis	before 2 weeks

Collaborators and Investigators

• Sponsor: Bir Hospital
• Collaborators: Nepal Health Research Council

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Mirabegron; Tamsulosin; Solifenacin
• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Tamsulosin; Solifenacin Succinate; mirabegron
• Other Study ID Numbers: BirH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No