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OpenTrials
Completed

NCT Number: NCT01880619

Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent 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.

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Key information

Conditions

Relieve of Ureteral Stent Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

Patients in this arm will receive Tamsulosin 0.4 mg daily

Other names: Tamsulin

solifenacin

Drug

Patients in the arm will receive Solifenacin

Other names: Sofinacin

Control

Drug

Patients in this are will receive placebo

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.