Post-market clinical follow-up (PMCF) study to investigate the percentage of relapses in treatment with KadeFungin® Milchsäurekur and its tolerability in female patients suffering from recurrent urinary tract infectio

• Conditions: N39.0; N30.2; Urinary tract infection, site not specified; Other chronic cystitis

• Registration Number: DRKS00016760
• Lead Sponsor: DR. KADE Pharmazeutische Fabrik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-18
• Study Completion: 2019-10-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

Signed informed consent form (ICF) and data privacy statement
- Female patients aged =18 years with recurrent acute uncomplicated urinary tract infection (rUTI): = 2 UTIs within the last 6 months or = 3 UTIs within the last 12 months

Exclusion Criteria

Patients with known hypersensitivity to any of the ingredients of KadeFungin® Milchsäurekur

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is defined as percentage of patients without a relapse, defined of UTI occurrence, after 4 months by monthly treatment with an applicator for 2 to 3 days.

Secondary Outcome Measures

Name	Time	Method
The following secondary endpoints will be evaluated:<br>- Patients without relapse after 1, 2, 3 and 4 months<br>- Change in vaginal pH value after 4 months<br>- Satisfaction with the therapy<br>- Moisturizing effect of KadeFungin® Milchsäurekur<br>- Adherence to the mode of application<br>- Handling of medical device<br>- Evaluation of the local tolerability <br>- Handling of untoward medical occurrences and ADE (Adverse Device Effect)<br>