Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Phase 4

• Conditions: Overactive Bladder
• Interventions: Drug: Solifenacin; Drug: Oxybutynin

• Registration Number: NCT01423838
• Lead Sponsor: Adana Numune Training and Research Hospital

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.

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 Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-26
• Last Update Posted: 2011-08-26
• Study Start: 2011-09
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solifenacin	Solifenacin	Anticholinergic molecule used in the treatment of overactive bladder.
Oxybutynin	Oxybutynin	Anticholinergic molecule used in the treatment of overactive bladder.

Primary Outcome Measures

Name	Time	Method
Degree of improvement in overactive bladder symptoms	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

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

Trial Locations

Locations (1)

Turkish Republic Ministry of Health Adana Numune Training and Research Hospital; 🇹🇷 Adana, Turkey