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

Sponsors

Lead Sponsor: Adana Numune Training and Research Hospital

Collaborator: Kocaeli University
Akdeniz University
Cukurova University
Baskent University
Ankara University
University of Gaziantep
Inonu University
Gaziosmanpasa University
Kahramanmaras Sutcu Imam University

Source 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.

Overall Status Unknown status
Start Date 2011-09-01
Completion Date 2012-09-01
Primary Completion Date 2012-09-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Degree of improvement in overactive bladder symptoms 2 months
Secondary Outcome
Measure Time Frame
To compare the degree of side effects between two study groups 2 months
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Solifenacin

Description: 5 mg, oral, once in a day

Arm Group Label: Solifenacin

Other Name: Kinzy

Intervention Type: Drug

Intervention Name: Oxybutynin

Description: 5 mg, oral, three times in a day

Arm Group Label: Oxybutynin

Other Name: Uropan

Eligibility

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. -

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Murat Api, M.D., Ph.D. Study Director Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
Overall Contact

Last Name: Murat Api, M.D., PhD.

Phone: +905424241807

Email: [email protected]

Location
Facility: Contact: Contact Backup: Turkish Republic Ministry of Health Adana Numune Training and Research Hospital Murat Api, M.D., Ph.D. +905424241807 [email protected]
Location Countries

Turkey

Verification Date

2011-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Adana Numune Training and Research Hospital

Investigator Full Name: Murat Api

Investigator Title: Associate Professor, M.D., Ph.D.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Solifenacin

Type: Active Comparator

Description: Anticholinergic molecule used in the treatment of overactive bladder.

Label: Oxybutynin

Type: Active Comparator

Description: Anticholinergic molecule used in the treatment of overactive bladder.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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