Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

Phase 4

Completed

• Conditions: Relieve of Ureteral Stent Symptoms
• Interventions: Drug: Control; Drug: Tamsulosin; Drug: Solifenacin

• Registration Number: NCT01880619
• Lead Sponsor: Mansoura University

Brief Summary

This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.

Detailed Description

Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-19
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Patient who will undergo unilateral ureteral stent fixation:

1. To relieve upper urinary tract obstruction caused by ureteric calculi
2. After ureteroscopic lithotripsy for ureteral calculi.

Exclusion Criteria

1. Patients who had LUTS before stent fixation.
2. Ureteral stent fixation after open or laparoscopic surgery.
3. Bilateral ureteral stents.
4. Patients who developed complications related to the primary endoscopic procedure
5. Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Control	Patients in this group will receive placebo
Group B	Tamsulosin	Patients in this group will receive Tamsulosin
Group C	Solifenacin	Patients in this group will receive Solifenacin

Primary Outcome Measures

Name	Time	Method
The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups	1 year

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Egypt