NCT07114848

Brief Summary

This study evaluates the effects of two medications-tamsulosin and solifenacin-on symptoms associated with double J (DJ) ureteral stents. The research is conducted among patients undergoing unilateral DJ stent placement for ureteric calculi or post-ureteroscopic lithotripsy. Participants are randomly assigned to receive either tamsulosin or solifenacin, and symptom severity is assessed using the Ureteral Stent Symptom Questionnaire (USSQ).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

July 17, 2025

Last Update Submit

August 6, 2025

Conditions

Ureteral Stent-Related SymptomAlpha BlockerAnticholinergicsUreter Calculi

Keywords

Tamsulosin vs solifenacin in improving stent related symptomsDouble J stentTamsulosinsolifencinureteral stent-related symptomsussqalpha-blockeranticholinergicRCTquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in total USSQ score

    Total score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health.

    14days post stent placement

Secondary Outcomes (5)

  • Urinary index score

    14days

  • Pain index score

    14days

  • General Health Index score

    14days

  • Work Performance Index Score

    14days

  • Sexual Function Index Score

    14days

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

Group A received tamsulosin starting within 24 hours after stent placement.

Drug: Tamsulosin

Solifenacin

ACTIVE COMPARATOR

Group B received solifenacin starting within 24 hours after stent placement.

Drug: solifenacin

Interventions

TamsulosinDRUG

Tamsulosin 0.4 mg once daily for 14 days

Also known as: Tamsolin
Tamsulosin
solifenacinDRUG

Solifenacin 5 mg once daily for 14 day

Also known as: solifen
Solifenacin

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 to 50 years
  • Undergoing unilateral DJ stenting for:
  • Ureteric calculi
  • Post-ureteroscopic lithotripsy

You may not qualify if:

  • Bilateral stents
  • History of LUTS or recurrent UTI
  • Urological malignancy or bladder surgery
  • Known hypersensitivity to alpha-blockers or anticholinergics
  • Uncontrolled hypertension, cardiovascular instability
  • Chronic liver or kidney disease
  • Stent complications (migration, encrustation, infection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital, Karachi, Pakistan

Karachi, Sindh, 75330, Pakistan

Location

MeSH Terms

Interventions

TamsulosinSolifenacin Succinate

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Resident

Study Record Dates

First Submitted

July 17, 2025

First Posted

August 11, 2025

Study Start

June 13, 2024

Primary Completion

December 30, 2024

Study Completion

March 30, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)