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Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

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ClinicalTrials.gov Identifier: NCT01423838
Recruitment Status : Unknown
Verified August 2011 by Murat Api, Adana Numune Training and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):

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
Overactive Bladder Drug: Solifenacin Drug: Oxybutynin 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  (Clinical Trial)
Estimated 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 : September 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Kinzy
Active Comparator: Oxybutynin
Anticholinergic molecule used in the treatment of overactive bladder.
Drug: Oxybutynin
5 mg, oral, three times in a day
Other Name: Uropan

Outcome Measures

Primary Outcome Measures :
  1. Degree of improvement in overactive bladder symptoms [ Time Frame: 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 [ Time Frame: 2 months ]
    Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

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): NCT01423838

Contact: Murat Api, M.D., PhD. +905424241807 muratapi@hotmail.com

Turkish Republic Ministry of Health Adana Numune Training and Research Hospital Not yet recruiting
Adana, Turkey, 01150
Contact: Murat Api, M.D., Ph.D.    +905424241807    muratapi@hotmail.com   
Contact: Hakan Aytan, M.D.    +905056833866    drhakanaytan@yahoo.com   
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
Study Director: Murat Api, M.D., Ph.D. Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
More Information

Responsible Party: Murat Api, Associate Professor, M.D., Ph.D., Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01423838     History of Changes
Other Study ID Numbers: Solifenacin vs Oxybutynin
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Murat Api, Adana Numune Training and Research Hospital:
Overactive bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mandelic Acids
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents