Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

November 23, 2015 updated by: Ahmed R. EL-Nahas, Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmed R EL-Nahas, A. Professor, Urology and nephrology center, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment of USS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relieve of Ureteral Stent Symptoms

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe