NCT06803030

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3

Timeline
8mo left

Started Aug 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

January 27, 2025

Last Update Submit

August 30, 2025

Conditions

Ureteral Stent-Related Symptom

Keywords

MirabegronTamsulosinSolifenacin

Outcome Measures

Primary Outcomes (1)

  • alleviating Ureteral stent related symptoms

    mitigating the ureteric stent related symptoms using structured questionnaire

    2 weeks

Secondary Outcomes (1)

  • early removal of ureteral stent

    before 2 weeks

Study Arms (3)

Tamsulosin group

ACTIVE COMPARATOR

placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom

Drug: Tamsulosin Hydrochloride 0.4 mg

Solifenacin group

ACTIVE COMPARATOR

placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom

Drug: Solifenacin Succinate 5 mg

Mirabegron group

ACTIVE COMPARATOR

placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom

Drug: Mirabegron 25 mg

Interventions

Tamsulosin Hydrochloride 0.4 mgDRUG

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

Also known as: Cap. Urimax 0.4 mg
Tamsulosin group
Solifenacin Succinate 5 mgDRUG

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

Also known as: Tab. Solay 5 mg
Solifenacin group
Mirabegron 25 mgDRUG

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

Also known as: Tab. Mirasin 25 mg
Mirabegron group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NAMS, Bir Hospital

Kathmandu, Bagmati, 44600, Nepal

RECRUITING

MeSH Terms

Interventions

TamsulosinSolifenacin Succinatemirabegron

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Baikuntha Adhikari, MCh

CONTACT

+977 9849896780baikadhe@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M Ch Urology Resident

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

August 30, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)