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Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Sponsor
Adana Numune Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01423838
Collaborator
Kocaeli University (Other), Akdeniz University (Other), Cukurova University (Other), Baskent University (Other), Ankara University (Other), University of Gaziantep (Other), Inonu University (Other), Gaziosmanpasa University (Other), Kahramanmaras Sutcu Imam University (Other)
500
Enrollment
1
Location
2
Arms
12
Duration (Months)
41.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
Study Start Date :
Sep 1, 2011
Anticipated Primary Completion Date :
Sep 1, 2012
Anticipated Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Solifenacin

Anticholinergic molecule used in the treatment of overactive bladder.

Drug: Solifenacin
5 mg, oral, once in a day
Other Names:
  • Kinzy

    		•
    Active Comparator: Oxybutynin

    Anticholinergic molecule used in the treatment of overactive bladder.

    Drug: Oxybutynin
    5 mg, oral, three times in a day
    Other Names:
  • Uropan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degree of improvement in overactive bladder symptoms [2 months]

      The main symptoms of overactive bladder are frequency, urgency, urge incontinence and nocturia (if any). The primary outcome of the trial will be comparison of the improvement of these symptoms in terms of number and severity between two study groups.

    Secondary Outcome Measures

    1. To compare the degree of side effects between two study groups [2 months]

      Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Women between 18-70 years of age, diagnosed to have overactive bladder (presence of at least two of the following three main criteria: urgency, urge incontinence, frequency and nocturia)

    Exclusion Criteria: Presence of stress urinary incontinence, patients who are still using a drug for overactive bladder, pregnant women, women in postpartum period (women on lactation), patients who have closed angle glaucoma, patients with chronic constipation, having allergy to the ingredients of the drugs, patients having the contraindicated conditions listed in the printed instructions of the drugs.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turkish Republic Ministry of Health Adana Numune Training and Research Hospital Adana Turkey 01150

    Sponsors and Collaborators

    • Adana Numune Training and Research Hospital
    • Kocaeli University
    • Akdeniz University
    • Cukurova University
    • Baskent University
    • Ankara University
    • University of Gaziantep
    • Inonu University
    • Gaziosmanpasa University
    • Kahramanmaras Sutcu Imam University

    Investigators

    • Study Director: Murat Api, M.D., Ph.D., Turkish Republic Ministry of Health Adana Numune Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murat Api, Associate Professor, M.D., Ph.D., Adana Numune Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01423838
    Other Study ID Numbers:
    • Solifenacin vs Oxybutynin
    First Posted:
    Aug 26, 2011
    Last Update Posted:
    Aug 26, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by Murat Api, Associate Professor, M.D., Ph.D., Adana Numune Training and Research Hospital
    Overactive bladder
    Solifenacin
    Oxybutynin
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Solifenacin Succinate
    Oxybutynin

    Study Results

    No Results Posted as of Aug 26, 2011