Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Study Overview
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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.

Official Title
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Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin
* Drug: Oxybutynin


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Solifenacin<br>Anticholinergic molecule used in the treatment of overactive bladder. | Drug: Solifenacin<br>* 5 mg, oral, once in a day<br>* Other names: Kinzy;|
| Active Comparator: Oxybutynin<br>Anticholinergic molecule used in the treatment of overactive bladder. | Drug: Oxybutynin<br>* 5 mg, oral, three times in a day<br>* Other names: Uropan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of improvement in overactive bladder symptoms | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the degree of side effects between two study groups | Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Solifenacin, Oxybutynin