Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms

Not Applicable

Completed

• Conditions: Stent Related Symptoms
• Interventions: Drug: Double dose tamsulosin and solifenacin; Drug: Single dose tamsulosin and solifenacin

• Registration Number: NCT06955533
• Lead Sponsor: Ain Shams University

Brief Summary

This study was a randomized clinical trial conducted on 64 Egyptian patients from the outpatient clinic at Ain Shams University Hospital over a six-month period from 3/2024 to 9/2024.The study population was randomized into 2 groups. Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg (Sofenacin® 10mg tab taken once daily).Group B included 32 patients with stent related symptoms receiving a standard dose of tamsulosin (0.4 mg once daily) and solifenacin (5 mg once daily).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• We included patients older than18 years of age, with presence of a double-J (DJ) stent in place, suffering from lower urinary tract symptoms (LUTS).Patients younger than 18 years of age, patients with a history of prostate or bladder surgery, lower urinary tract procedures, cancer, neurological conditions, pelvic radiation, diabetes, kidney dysfunction (acute or chronic), a solitary kidney, congenital urinary anomalies, or those taking medications such as α-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates were excluded. Additionally, patients with cardiac issues, residual stone fragments after surgery, multiple or bilateral ureteral stones, long-term or bilateral stents requiring frequent changes, interstitial cystitis, chronic cystitis, prostatitis, pregnant or breastfeeding women, and those unavailable for follow-up were also excluded from the study.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double dose tamsulosin ans solifenacin	Double dose tamsulosin and solifenacin	-
Single dose tamsulosin and solifenacin	Single dose tamsulosin and solifenacin	-

Primary Outcome Measures

Name	Time	Method
Improvement of ussq	2 weeks	This is a pilot study aiming to evaluate the effectiveness of Double dose versus standard dose of tamsulosin with solifenacin in relieving stent related symptoms.

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt