Post Marketing Surveillance Study on Emselex After Launch in Germany

Post-Marketing Surveillance Study Emselex

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00786448

Enrollment

5821

Registered

2008-11-06

Start date

2005-01-31

Completion date

2006-02-28

Last updated

2010-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Overactive Bladder

Brief summary

\- 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.

Interventions

DRUGDarifenacin, Emselex (BAY79-4998)

Patients from routine practice

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who are treated with Emselex for Overactive Bladder

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Adverse events, Adverse drug reactions, physician's global assessment of tolerability	After 2-3 months of treatment (long-term 6 months)

Secondary

Measure	Time frame
Urgency episodes	At end of study
Micturitions / nycturitions	At end of study
Physician's assessment of improvement/efficacy	At end of study
Incontinence	At end of study
Physician's assessment of patient's ability to hold urine	At end of study
Dose and treatment duration of Emselex	At end of study
Physician's assessment of patient's satisfaction with therapeutic effect	At end of study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026