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Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

This study is not yet open for participant recruitment.
Verified August 2011 by Adana Numune Training and Research Hospital
Sponsor:
Collaborators:
Kocaeli University
Akdeniz University
Cukurova University
Baskent University
Ankara University
University of Gaziantep
Inonu University
Tokat Gaziosmanpasa University
Kahramanmaras Sutcu Imam University
Information provided by (Responsible Party):
Murat Api, Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01423838
First received: August 25, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
 Drug: Solifenacin
Drug: Oxybutynin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Adana Numune Training and Research Hospital:

Primary Outcome Measures:
  • Degree of improvement in overactive bladder symptoms [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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:
  • To compare the degree of side effects between two study groups [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.


Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Solifenacin
Anticholinergic molecule used in the treatment of overactive bladder.
 Drug: Solifenacin
5 mg, oral, once in a day
Other Name: Kinzy
Active Comparator: Oxybutynin
Anticholinergic molecule used in the treatment of overactive bladder.
 Drug: Oxybutynin
5 mg, oral, three times in a day
Other Name: Uropan

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423838

Contacts
Contact: Murat Api, M.D., PhD. +905424241807 muratapi@hotmail.com

Locations
Turkey
Turkish Republic Ministry of Health Adana Numune Training and Research Hospital Not yet recruiting
Adana, Turkey, 01150
Contact: Murat Api, M.D., Ph.D.     +905424241807     muratapi@hotmail.com    
Contact: Hakan Aytan, M.D.     +905056833866     drhakanaytan@yahoo.com    
Sponsors and Collaborators
Adana Numune Training and Research Hospital
Kocaeli University
Akdeniz University
Cukurova University
Baskent University
Ankara University
University of Gaziantep
Inonu University
Tokat Gaziosmanpasa University
Kahramanmaras Sutcu Imam University
Investigators
Study Director: Murat Api, M.D., Ph.D. Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
  More Information

No publications provided

Responsible Party: Murat Api, Associate Professor, M.D., Ph.D., Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01423838     History of Changes
Other Study ID Numbers: Solifenacin vs Oxybutynin
Study First Received: August 25, 2011
Last Updated: August 25, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Adana Numune Training and Research Hospital:
Overactive bladder
Solifenacin
Oxybutynin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Oxybutynin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013