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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07114848
Enrollment
60
Registered
2025-08-11
Start date
2024-06-13
Completion date
2025-03-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Tamsulosin vs solifenacin in improving stent related symptoms, Double J stent, Tamsulosin, solifencin, ureteral stent-related symptoms, ussq, alpha-blocker, anticholinergic, RCT, quality of life

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.

Interventions

DRUGTamsulosin

Tamsulosin 0.4 mg once daily for 14 days

DRUGsolifenacin

Solifenacin 5 mg once daily for 14 day

Sponsors

Liaquat National Hospital & Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in total USSQ score14days post stent placementTotal score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health.

Secondary

MeasureTime frame
Urinary index score14days
Pain index score14days
General Health Index score14days
Work Performance Index Score14days
Sexual Function Index Score14days

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026