Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

NCT01880619 | Completed Phase 4 DMC

• 1 other identifier: Treatment of USS
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Relieve of Ureteral Stent Symptoms

Keywords

Double J; Ureteral stents; Symptoms; Alpha blockers; Anticholinergic

Outcome Measures

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

  1 year

Study Arms (3)

Group A

PLACEBO COMPARATOR

Patients in this group will receive placebo

Drug: Control

Group B

ACTIVE COMPARATOR

Patients in this group will receive Tamsulosin

Drug: Tamsulosin

Group C

ACTIVE COMPARATOR

Patients in this group will receive Solifenacin

Drug: Solifenacin

Interventions

Tamsulosin DRUG

Patients in this arm will receive Tamsulosin 0.4 mg daily

Also known as: Tamsulin

Group B

Solifenacin DRUG

Patients in the arm will receive Solifenacin

Also known as: Sofinacin

Group C

Control DRUG

Patients in this are will receive placebo

Group A

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient who will undergo unilateral ureteral stent fixation:
• To relieve upper urinary tract obstruction caused by ureteric calculi
• After ureteroscopic lithotripsy for ureteral calculi.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• El-Nahas AR, Tharwat M, Elsaadany M, Mosbah A, Gaballah MA. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms. World J Urol. 2016 Jul;34(7):963-8. doi: 10.1007/s00345-015-1704-3. Epub 2015 Oct 9.

  PMID: 26453222 DERIVED

MeSH Terms

Interventions

Tamsulosin; Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmed R EL-Nahas, A. Professor

  Urology and Nephrology Center, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 19, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 25, 2015

Record last verified: 2015-08

Locations

EG (1)