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OpenTrials
Completed

NCT Number: NCT00786448

Post Marketing Surveillance Study on Emselex After Launch in Germany

- Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.

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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, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are treated with Emselex for Overactive Bladder

Exclusion criteria

  • Exclusion criteria are the contraindications as specified in the German product information

Treatment and study plan

Darifenacin, Emselex (BAY79-4998)

Drug

Patients from routine practice

Primary outcomes

  1. Adverse events, Adverse drug reactions, physician's global assessment of tolerability

    Time frame: After 2-3 months of treatment (long-term 6 months)

Secondary outcomes

  1. Incontinence

    Time frame: At end of study

  2. Urgency episodes

    Time frame: At end of study

  3. Micturitions / nycturitions

    Time frame: At end of study

  4. Physician's assessment of improvement/efficacy

    Time frame: At end of study

  5. Physician's assessment of patient's satisfaction with therapeutic effect

    Time frame: At end of study

  6. Physician's assessment of patient's ability to hold urine

    Time frame: At end of study

  7. Dose and treatment duration of Emselex

    Time frame: At end of study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Post-Marketing Surveillance Study Emselex

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 6, 2008
Registry last updated
Apr 30, 2010

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.

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