Trial | NCT01423838  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    500
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.
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 Started
Sep 30
2011
Primary Completion
Sep 30
2012
Anticipated
Study Completion
Sep 30
2012
Anticipated
Last Update
Aug 26
2011
Estimate

Drug Solifenacin

5 mg, oral, once in a day

  • Other names: Kinzy

Drug Oxybutynin

5 mg, oral, three times in a day

  • Other names: Uropan

Solifenacin Active Comparator

Anticholinergic molecule used in the treatment of overactive bladder.

Oxybutynin Active Comparator

Anticholinergic molecule used in the treatment of overactive bladder.

Criteria 

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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No Results Posted