FREEDOM - First Real-Life Evaluation of Enablex Done in ZA Overactive Bladder Patients During a 3 Months Period

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Darifenacin (Emselex, BAY79-4998)

• Registration Number: NCT00921245
• Lead Sponsor: Bayer

Brief Summary

Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-10
• Study Completion: 2009-02
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Male and female patients > 18 years with symptoms of overactive bladder.

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Exclusion Criteria

• Contraindications for the treatment with Darifenacin prolonged-release tablets according to the registered package insert.
• Pregnancy and lactation. Women of childbearing potential have to use an acceptable method of contraception.
• Concomitant treatment with drugs known to affect mainly the urinary bladder function (e.g. anticholinergics, antispasmodics) at any time during the study. Concomitant treatment with botulinum toxin, capsaicin or resiniferatoxin at any time during the study and treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 1.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Darifenacin (Emselex, BAY79-4998)	-

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.	3 months later

Secondary Outcome Measures

Name	Time	Method
To evaluate the patient's perception of bladder condition, the patient's use of the patient support program, the patient's and physician's assessment of treatment regarding efficacy and tolerability and patient's compliance with the treatment	3 months later