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

Liaquat National Hospital & Medical College

Status and phase: Completed; Phase 4

Conditions: Ureter Calculi; Anticholinergics; Alpha Blocker; Ureteral Stent-Related Symptom

Treatments: Drug: solifenacin; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT07114848

0996-2024-LNH-ERC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Tamsulosin

Active Comparator group

Description:

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

Treatment:

Drug: Tamsulosin

Solifenacin

Active Comparator group

Description:

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

Treatment:

Drug: solifenacin