Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

NCT ID: NCT01423838

Last Updated: 2011-08-26

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.

Detailed Description

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In this two-month follow-up study, the patients with overactive bladder will be randomly assigned into two groups (solifenacin or oxybutynin in their usual doses) and will be assessed with respect to baseline characteristics and complaints before treatment. After initiation of the treatment at first and second months follow-up visits the patients will be reassessed with respect to compliance, satisfaction, degree of improvement, reasons for dropouts, number and severity of side effects.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Solifenacin

Anticholinergic molecule used in the treatment of overactive bladder.

Group Type ACTIVE_COMPARATOR

Solifenacin

Intervention Type DRUG

5 mg, oral, once in a day

Oxybutynin

Anticholinergic molecule used in the treatment of overactive bladder.

Group Type ACTIVE_COMPARATOR

Oxybutynin

Intervention Type DRUG

5 mg, oral, three times in a day

Interventions

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Solifenacin

5 mg, oral, once in a day

Intervention Type DRUG

Oxybutynin

5 mg, oral, three times in a day

Intervention Type DRUG

Other Intervention Names

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Kinzy Uropan

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role collaborator

Akdeniz University

OTHER

Sponsor Role collaborator

Cukurova University

OTHER

Sponsor Role collaborator

Baskent University

OTHER

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role collaborator

University of Gaziantep

OTHER

Sponsor Role collaborator

Inonu University

OTHER

Sponsor Role collaborator

Gaziosmanpasa University

UNKNOWN

Sponsor Role collaborator

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role collaborator

Adana Numune Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Murat Api

Associate Professor, M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Api, M.D., Ph.D.

Role: STUDY_DIRECTOR

Turkish Republic Ministry of Health Adana Numune Training and Research Hospital

Locations

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Turkish Republic Ministry of Health Adana Numune Training and Research Hospital

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Murat Api, M.D., PhD.

Role: CONTACT

+905424241807

Facility Contacts

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Murat Api, M.D., Ph.D.

Role: primary

+905424241807

Hakan Aytan, M.D.

Role: backup

+905056833866

Other Identifiers

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Solifenacin vs Oxybutynin

Identifier Type: -

Identifier Source: org_study_id

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