Comparing Tamsulosin and Solifenacin for Relieving Double J Stent Symptoms: Using the USSQ.

Not Applicable

Completed

• Conditions: Ureteral Stent-Related Symptom; Alpha Blocker; Anticholinergics; Ureter Calculi
• Interventions: Drug: Tamsulosin; Drug: solifenacin

• Registration Number: NCT07114848
• Lead Sponsor: Liaquat National Hospital & Medical College

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).

Detailed Description

Ureteral stents are widely used in urological procedures but are frequently associated with stent-related symptoms such as urinary urgency, pain, and reduced quality of life. These symptoms are believed to arise from mechanical irritation and bladder overactivity. Alpha-blockers and antimuscarinic agents are commonly prescribed to alleviate these effects. This study is designed to compare the effects of tamsulosin, an alpha-1 adrenergic receptor antagonist, and solifenacin, a muscarinic M3 receptor antagonist, in reducing DJ stent-related symptoms.

The study is a single-center, randomized clinical trial conducted at the Department of Urology, Liaquat National Hospital, Karachi. Sixty adult patients who undergo unilateral DJ stent placement for ureteric stones or after ureteroscopic lithotripsy are randomized into two equal groups. Group A receives tamsulosin 0.4 mg daily, and Group B receives solifenacin 5 mg daily. Symptom evaluation is performed on day 14 post-procedure using a culturally adapted version of the Ureteral Stent Symptom Questionnaire (USSQ), which assesses domains such as urinary symptoms, pain, general health, work performance, and sexual health.

The findings from this study aim to inform treatment decisions for managing stent-related symptoms in similar clinical populations.

Study Timeline

• Study Start: 2024-06-13
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-30
• Study First Submitted: 2025-07-17
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin	Tamsulosin	Group A received tamsulosin starting within 24 hours after stent placement.
Solifenacin	solifenacin	Group B received solifenacin starting within 24 hours after stent placement.

Primary Outcome Measures

Name	Time	Method
Change in total USSQ score	14days post stent placement	Total score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health.

Secondary Outcome Measures

Name	Time	Method
Pain index score	14days
General Health Index score	14days
Work Performance Index Score	14days
Urinary index score	14days
Sexual Function Index Score	14days

Trial Locations

Locations (1)

Liaquat National Hospital, Karachi, Pakistan; 🇵🇰 Karachi, Sindh, Pakistan