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Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

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ClinicalTrials.gov Identifier: NCT01880619
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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 Name: Tamsulin

Active Comparator: Group C
Patients in this group will receive Solifenacin
Drug: Solifenacin
Patients in the arm will receive Solifenacin
Other Name: Sofinacin




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880619


Locations
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Egypt
Urology and Nephrology Center
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed R EL-Nahas, A. Professor Urology and Nephrology Center, Mansoura University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed R. EL-Nahas, Assistant Professor, Mansoura University
ClinicalTrials.gov Identifier: NCT01880619     History of Changes
Other Study ID Numbers: Treatment of USS
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: August 2015
Keywords provided by Ahmed R. EL-Nahas, Mansoura University:
Double J
Ureteral stents
Symptoms
Alpha blockers
Anticholinergic
Additional relevant MeSH terms:
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Tamsulosin
Solifenacin Succinate
Cholinergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Agents