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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


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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.


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.


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

Page last updated: August 23, 2015

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