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 infection

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 infection - PANAMA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016760

Enrollment

Registered

2019-02-18

Start date

2019-02-25

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

N39.0 N30.2

Interventions

Group 1: Treatment with KadeFungin® Milchsäurekur In the scope of this observational study no intervention is planned. The recommendation of application of KadeFungin® Milchsäurekur will take place b

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactBettina Schopf

Pharmalog Institut für klinische Forschung GmbH

schopf@pharmalog.com+49 (0) 89 544637-53

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026