- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423838
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Murat Api, M.D., PhD.
- Phone Number: +905424241807
- Email: muratapi@hotmail.com
Study Locations
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Adana, Turkey, 01150
- Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
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Contact:
- Murat Api, M.D., Ph.D.
- Phone Number: +905424241807
- Email: muratapi@hotmail.com
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Contact:
- Hakan Aytan, M.D.
- Phone Number: +905056833866
- Email: drhakanaytan@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Solifenacin
Anticholinergic molecule used in the treatment of overactive bladder.
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5 mg, oral, once in a day
Other Names:
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Active Comparator: Oxybutynin
Anticholinergic molecule used in the treatment of overactive bladder.
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5 mg, oral, three times in a day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of improvement in overactive bladder symptoms
Time Frame: 2 months
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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.
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the degree of side effects between two study groups
Time Frame: 2 months
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Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.
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2 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Murat Api, M.D., Ph.D., Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Oxybutynin
- Solifenacin Succinate
Other Study ID Numbers
- Solifenacin vs Oxybutynin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Solifenacin
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Astellas Pharma Europe B.V.CompletedPediatric | Neurogenic Detrusor OveractivityUnited States, Belgium, Korea, Republic of, Philippines, Poland, United Kingdom
-
Astellas Pharma Europe Ltd.CompletedOveractive Bladder (OAB) | Lower Urinary Tract Symptoms (LUTS)Ireland
-
Astellas Pharma IncCompletedUrinary Bladder, OveractiveSweden, United Kingdom, Belgium, Denmark
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Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin Succinate | Bioavailability of Solifenacin SuccinateUnited States
-
Hanmi Pharmaceutical Company LimitedCompleted
-
Lahey ClinicAstellas Pharma US, Inc.TerminatedOveractive BladderUnited States
-
Astellas Pharma Europe B.V.CompletedUrinary Bladder, OveractiveBelgium, United States, Brazil, Canada, Denmark, Former Serbia and Montenegro, Korea, Republic of, Mexico, Norway, Philippines, Poland, South Africa, Sweden, Turkey, Ukraine, United Kingdom
-
Center Eugene MarquisTerminated
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National Taiwan University HospitalUnknownOveractive Bladder SyndromeTaiwan
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Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin SuccinateUnited States