Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

NCT ID: NCT01880619

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Relieve of Ureteral Stent Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Patients in this group will receive placebo

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Patients in this are will receive placebo

Group B

Patients in this group will receive Tamsulosin

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Patients in this arm will receive Tamsulosin 0.4 mg daily

Group C

Patients in this group will receive Solifenacin

Group Type ACTIVE_COMPARATOR

Solifenacin

Intervention Type DRUG

Patients in the arm will receive Solifenacin

Interventions

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Tamsulosin

Patients in this arm will receive Tamsulosin 0.4 mg daily

Intervention Type DRUG

Solifenacin

Patients in the arm will receive Solifenacin

Intervention Type DRUG

Control

Patients in this are will receive placebo

Intervention Type DRUG

Other Intervention Names

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Tamsulin Sofinacin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed R. EL-Nahas

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed R EL-Nahas, A. Professor

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology Center, Mansoura University

Locations

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Urology and Nephrology Center

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 26453222 (View on PubMed)

Other Identifiers

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Treatment of USS

Identifier Type: -

Identifier Source: org_study_id