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

N/ACompletedNCT00921245

Bayer9 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Overactive Bladder

Interventions

Darifenacin (Emselex, BAY79-4998)DRUG

Patients in daily clinical treatment receiving Emselex according to local drug information

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients \> 18 years with symptoms of overactive bladder. 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.

Locations (1)

Unnamed facility

Many Locations, South Africa

Outcomes

Primary Outcomes

To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.

Time frame: 3 months later

Secondary Outcomes

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

Time frame: 3 months later

Data from ClinicalTrials.gov

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