Trial document




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  DRKS00016760

Trial Description

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Title

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

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Trial Acronym

PANAMA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Primary objective:
The primary objective of this observational study is the evaluation of the percentage of relapses of an acute urinary tract infection in female patients suffering from a relapsing urinary tract infection. The female patients will treat themselves monthly for 2-3 days over a period of 4 months with KadeFungin® Milchsäurekur. Furthermore the course of symptoms will be observed and documented in a diary during the observation period and the patients will evaluate their satisfaction, tolerability, acceptance and handling of the product.
The collection of these data enables to generate clinical data. These clinical data serve as data base for further studies of the manufacturer, where appropriate. The collection of these data within the setting of an observational study is part of the responsibility of the manufacturer for post market surveillance, but no proof of concept will be done within this study.

Current level of expertise:
In women, the vaginal flora plays a key role in the pathogenesis of UTIs. The vaginal microbiota is the ultimate source of bacterial strains causing cystitis and pyelonephritis in the majority of cases. The initial step in the pathogenesis of UTI is colonization of the vaginal with the infecting uropathogens, followed by ascension of uropathogens via the urethra to the bladder and sometimes the kidneys to cause infection. The lactic acid in KadeFungin® Milchsäurekur recovers in case of an imbalance (weakly acid to slightly alkaline) of the vaginal environment that the physiological balance of the genital area including the urethra. Lactic acid bacteria build a natural protection of the healthy vaginal flora, KadeFungin® Milchsäurekur with pH-value 4 contributes to the regeneration and stabilization of the natural protective acid mantle and inhibits the invasion and increase of undesired germs in the whole genital area. The current level of expertise is described in the user manual (status: April 2016).

Useful gain in knowledge:
A gain of knowledge about tolerability and acceptance of KadeFungin® Milchsäurekur as well as satisfaction of the female patients with this product will be expected. Also the data will be gained for the use of the medicinal product under routine conditions in the daily practice and a statement for the amount of relapses during the treatment period for 4 months the intake will be collected. In the scope of this study no proof of concept will be striven.

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Brief Summary in Scientific Language

The main objective of this observational study is to investigate the percentage of relapses in treatment with KadeFungin® Milchsäurekur and its tolerability in adult female patients with recurrent acute uncomplicated urinary tract infections (rUTI) in order to fulfil manufacturer´s responsibility in post-market surveillance.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00016760
  •   2019/02/18
  •   [---]*
  •   no
  •   No approval required according to EC
  •   18087, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N39.0 -  Urinary tract infection, site not specified
  •   N30.2 -  Other chronic cystitis
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Interventions/Observational Groups

  •   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 before and regardless of the participation in this study. Only after this decision of the treating physician took place, the patient will be informed about the possibility of participation at this study and her written consent will be obtained.
    Within this observational study it is planned to obtain information about the effective application of KadeFungin® Milchsäurekur during the course of the study, about the number of relapses and about the tolerability of KadeFungin® Milchsäurekur during treatment period. Therefore the following data will be gathered for the purpose of evaluation.
    During the visit in the physician’s office following data will be collected: year of birth and age in years, number of recurrent acute urinary tract infections within the last half-year or the last year, respectively, before the day of the visit, medical history related to the urinary tract infections and the vagina pH level (optionally).
    At home, the following data will be queried on the basis of a diary – once a month – for a period of 4 months: occurrence(s) of an acute urinary tract infection, change in the medical condition of the patient (e.g. side effects of KadeFungin® Milchsäurekur), information about the application of the product.
    Once after 4 months the patient gives information about her satisfaction with the product and its tolerability, she assesses the handling and the additional moisturizing effect of KadeFungin® Milchsäurekur.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/02/25
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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

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Exclusion Criteria

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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • DR. KADE Pharmazeutische Fabrik GmbH
    • Ms.  Dr. rer. nat.  Ruth  Diebold 
    • Rigistrasse 2
    • 12277  Berlin
    • Germany
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    •   +49 (0)30 / 72082 412
    •   +49 (0)30 / 72082 283
    •   RuthDiebold at kade.de
    •   [---]*
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    • Deutsches Zentrum für Gynäkologie und Geburtshilfe an der Landesfrauenklinik, Universitätsklinikum Wuppertal - Universität Witten/Herdecke
    • Mr.  Prof. Dr. med.  Werner  Mendling 
    • Heusnerstr. 40
    • 42283  Wuppertal
    • Germany
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    • Pharmalog Institut für klinische Forschung GmbH
    • Ms.  Bettina  Schopf 
    • Oskar-Messter-Str. 29
    • 85737  Ismaning
    • Germany
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Sources of Monetary or Material Support

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    • DR. KADE Pharmazeutische Fabrik GmbH
    • Ms.  Dr. rer. nat.  Ruth  Diebold 
    • Rigistrasse 2
    • 12277  Berlin
    • Germany
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    •   +49 (0)30 / 72082 412
    •   +49 (0)30 / 72082 283
    •   RuthDiebold at kade.de
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/10/07
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.