Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01880619

Collaborator

(none)

131

Enrollment

Location

Arms

17.9

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relieve of Ureteral Stent Symptoms	Drug: Tamsulosin Drug: Solifenacin Drug: Control	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group A Patients in this group will receive placebo	Drug: Control Patients in this are will receive placebo
Active Comparator: Group B Patients in this group will receive Tamsulosin	Drug: Tamsulosin Patients in this arm will receive Tamsulosin 0.4 mg daily Other Names: Tamsulin
Active Comparator: Group C Patients in this group will receive Solifenacin	Drug: Solifenacin Patients in the arm will receive Solifenacin Other Names: Sofinacin

Arm

Intervention/Treatment

Placebo Comparator: Group A

Patients in this group will receive placebo

Drug: Control

Patients in this are will receive placebo

Active Comparator: Group B

Patients in this group will receive Tamsulosin

Drug: Tamsulosin

Patients in this arm will receive Tamsulosin 0.4 mg daily

Other Names:

Tamsulin

Active Comparator: Group C

Patients in this group will receive Solifenacin

Drug: Solifenacin

Patients in the arm will receive Solifenacin

Other Names:

Sofinacin

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient who will undergo unilateral ureteral stent fixation:

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

Exclusion Criteria:

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