Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Overview

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.

Full Title of Study: “Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

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.

Interventions

  • Drug: Solifenacin
    • 5 mg, oral, once in a day
  • Drug: Oxybutynin
    • 5 mg, oral, three times in a day

Arms, Groups and Cohorts

  • Active Comparator: Solifenacin
    • Anticholinergic molecule used in the treatment of overactive bladder.
  • Active Comparator: Oxybutynin
    • Anticholinergic molecule used in the treatment of overactive bladder.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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. -

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Adana Numune Training and Research Hospital
  • Collaborator
    • Kocaeli University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Murat Api, Associate Professor, M.D., Ph.D. – Adana Numune Training and Research Hospital
  • Overall Official(s)
    • Murat Api, M.D., Ph.D., Study Director, Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
  • Overall Contact(s)
    • Murat Api, M.D., PhD., +905424241807, muratapi@hotmail.com

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