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Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Solifenacin
Oxybutynin
Sponsored by
Adana Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Solifenacin, Oxybutynin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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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Sites / Locations

  • Turkish Republic Ministry of Health Adana Numune Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Solifenacin

Oxybutynin

Arm Description

Anticholinergic molecule used in the treatment of overactive bladder.

Anticholinergic molecule used in the treatment of overactive bladder.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 25, 2011
Last Updated
August 25, 2011
Sponsor
Adana Numune Training and Research Hospital
Collaborators
Kirsehir Ahi Evran University, Akdeniz University, Cukurova University, Baskent University, Ankara University, University of Gaziantep, Inonu University, Gaziosmanpasa University, Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT01423838
Brief Title
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
Official Title
Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adana Numune Training and Research Hospital
Collaborators
Kirsehir Ahi Evran University, Akdeniz University, Cukurova University, Baskent University, Ankara University, University of Gaziantep, Inonu University, Gaziosmanpasa University, Kahramanmaras Sutcu Imam University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive bladder, Solifenacin, Oxybutynin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin
Arm Type
Active Comparator
Arm Description
Anticholinergic molecule used in the treatment of overactive bladder.
Arm Title
Oxybutynin
Arm Type
Active Comparator
Arm Description
Anticholinergic molecule used in the treatment of overactive bladder.
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Other Intervention Name(s)
Kinzy
Intervention Description
5 mg, oral, once in a day
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Uropan
Intervention Description
5 mg, oral, three times in a day
Primary Outcome Measure Information:
Title
Degree of improvement in overactive bladder symptoms
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
To compare the degree of side effects between two study groups
Description
Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murat Api, M.D., PhD.
Phone
+905424241807
Email
muratapi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Api, M.D., Ph.D.
Organizational Affiliation
Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
City
Adana
ZIP/Postal Code
01150
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Api, M.D., Ph.D.
Phone
+905424241807
Email
muratapi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hakan Aytan, M.D.
Phone
+905056833866
Email
drhakanaytan@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

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