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

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

Completed

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darifenacin (Emselex, BAY79-4998)

Drug

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

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

First REal-life Evaluation of Darifenacin in Overactive Bladder Patients During 3 Months

Acronym: FREEDOM

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Jun 16, 2009
Registry last updated: Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed