Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01423838
• Other study ID #: Solifenacin vs Oxybutynin
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 25, 2011
• Last updated: August 25, 2011
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2011
• Source: Adana Numune Training and Research Hospital
• Contact: Murat Api, M.D., PhD.
• Phone: +905424241807
• Email: muratapi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Turkey	Turkish Republic Ministry of Health Adana Numune Training and Research Hospital	Adana

Sponsors (10)

Lead Sponsor	Collaborator
Adana Numune Training and Research Hospital	Akdeniz University, Ankara University, Baskent University, Cukurova University, Gaziosmanpasa University, Inonu University, Kahramanmaras Sutcu Imam University, Kocaeli University, University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No