NCT07114848

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

Comparative Efficacy of Tamsulosin and Solifenacin in Managing Double J Stent-Related Symptoms: A Randomized Clinical Study Using the USSQ Tool.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Liaquat National Hospital & Medical College · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ureteral Stent-Related Symptom
• Alpha Blocker
• Anticholinergics
• Ureter Calculi

Interventions

Type	Name	Description
DRUG	Tamsulosin	Tamsulosin 0.4 mg once daily for 14 days
DRUG	solifenacin	Solifenacin 5 mg once daily for 14 day

Timeline

• Start date: 2024-06-13
• Primary completion: 2024-12-30
• Completion: 2025-03-30
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: Pakistan