Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
Information source: Adana Numune Training and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: Solifenacin (Drug); Oxybutynin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Adana Numune Training and Research Hospital Official(s) and/or principal investigator(s):
Murat Api, M.D., Ph.D., Study Director, Affiliation: Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
Overall contact:
Murat Api, M.D., PhD., Phone: +905424241807, Email: muratapi@hotmail.com
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.
Clinical Details
Official title: Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Degree of improvement in overactive bladder symptoms
Secondary outcome: To compare the degree of side effects between two study groups
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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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Locations and Contacts
Murat Api, M.D., PhD., Phone: +905424241807, Email: muratapi@hotmail.com
Turkish Republic Ministry of Health Adana Numune Training and Research Hospital, Adana 01150, Turkey; Not yet recruiting
Murat Api, M.D., Ph.D., Phone: +905424241807, Email: muratapi@hotmail.com
Hakan Aytan, M.D., Phone: +905056833866, Email: drhakanaytan@yahoo.com
Additional Information
Starting date: September 2011
Last updated: August 25, 2011
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