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Prevention of Cystitis.

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ClinicalTrials.gov Identifier: NCT03744338
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

3436/5000 Urinary tract infections are a real public health issue. The frequency of these infections in France is estimated between 6 and 8 million in primary care (1) which represents 15% of antibiotics prescribed in primary care. Approximately 40-50% of women have had at least one UTI during their lifetime. (4) There is also an ecological issue by increasing the resistance of bacteria to antibiotics. (6) (7) The goal is to assess patients' knowledge and understandings to improve primary prevention.

The secondary objective will be to identify the demographic, sociological and ethiologic factors that may influence the knowledge and behavior of patients consulting in general medicine concerning means of prevention of cystitis.

This exploratory descriptive study is carried out on the basis of an anonymous questionnaire distributed in waiting rooms of GP offices after drawing lots in the former Auvergne region with prior approval of doctors. The inclusion criterion is to be a woman aged 18 to 65, consultant in general medicine.

24 general practitioners will be drawn in proportion to the distribution by department of the former region of Auvergne.

The primary outcome measure is to assess patients' knowledge and behaviors about how to prevent cystitis from responses to questionnaire items

. The duration of the study will be 6 weeks. The questionnaire consists of a section on the characteristics of patients including age, BMI, socio-professional category, current treatments, medico-surgical antecedents of interest and the other part consisting of 16 questions. on preventative measures to avoid cystitis with simple answers divided into "did you know" and "do it yourself", two questions about ecology and two other questions about lifestyle and other preventive practices.

It will also be collected data on the selected doctors: age, location, gynecological acts associated with general medicine.

The statistical analysis will be carried out with the software Stata . All statistical tests will be carried out at the risk of error of the first kind α of 5%. Patients will be described according to the variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and treatments. These analyzes will be complemented by the usual statistical tests, for example Chi2 test or Fisher-exact test for the comparison of categorical and anova variables or Kruskal-Wallis test if necessary for the quantitative variables. It seems difficult to propose for this exploratory observational study an estimate of the number of necessary subjects sufficiently robust and relevant. Nevertheless, it has been agreed to include at least 800 patients to establish possible specific profiles associated with patient knowledge and behavior The protocol, the information and consent form and the questionnaire were submitted for opinion to the Protection to Persons Committee.


Condition or disease Intervention/treatment
Woman Aged 18 to 65 Other: questionnaire

Detailed Description:

3436/5000 Urinary tract infections are a real public health issue. The frequency of these infections in France is estimated between 6 and 8 million in primary care (1) which represents 15% of antibiotics prescribed in primary care. Approximately 40-50% of women have had at least one UTI during their lifetime. (4) There is also an ecological issue by increasing the resistance of bacteria to antibiotics. (6) The goal is to assess patients' knowledge and understandings to improve primary prevention.

The secondary objective will be to identify the demographic, sociological and ethiologic factors that may influence the knowledge and behavior of patients consulting in general medicine concerning means of prevention of cystitis.

This exploratory descriptive study is carried out on the basis of an anonymous questionnaire distributed in waiting rooms of GP offices after drawing lots in the former Auvergne region with prior approval of doctors. The inclusion criterion is to be a woman aged 18 to 65, consultant in general medicine.

24 general practitioners will be drawn in proportion to the distribution by department of the former region of Auvergne.

The primary outcome measure is to assess patients' knowledge and behaviors about how to prevent cystitis from responses to questionnaire items

. The duration of the study will be 6 weeks. The questionnaire consists of a section on the characteristics of patients including age, BMI, socio-professional category, current treatments, medico-surgical antecedents of interest and the other part consisting of 16 questions. on preventative measures to avoid cystitis with simple answers divided into "did you know" and "do it yourself", two questions about ecology and two other questions about lifestyle and other preventive practices.

It will also be collected data on the selected doctors: age, location, gynecological acts associated with general medicine.

The statistical analysis will be carried out with the software Stata All statistical tests will be carried out at the risk of error of the first kind α of 5%. Patients will be described according to the variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and treatments. These analyzes will be complemented by the usual statistical tests, for example Chi2 test or Fisher-exact test for the comparison of categorical and anova variables or Kruskal-Wallis test if necessary for the quantitative variables. It seems difficult to propose for this exploratory observational study an estimate of the number of necessary subjects sufficiently robust and relevant. Nevertheless, it has been agreed to include at least 800 patients to establish possible specific profiles associated with patient knowledge and behavior The protocol, the information and consent form and the questionnaire were submitted for opinion to the Protection to Persons Committee.


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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Non-antibiotic Primary Prevention of Low Urinary Tract Infections: Evaluation of the Knowledge and Practices of Patients in the General Practitioner's Office, Observational and Descriptive Study in the Former Auvergne Region in France.
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Group/Cohort Intervention/treatment
Group 1 Other: questionnaire

The questionnaire is composed of two parts:

The first part let know the characteristics of the patients as age, the BMI, the socio-professional category, the current treatments, the medical-surgical antecedents of interest.





Primary Outcome Measures :
  1. Assessment of patients' knowledge and behaviors on means of prevention of cystitis from responses to questionnaire items [ Time Frame: at 6 weeks ]

    The questionnaire is composed of two parts:

    The first part let know the characteristics of the patients as age, the BMI, the socio-professional category, the current treatments, the medical-surgical antecedents of interest.

    The other part consists of

    • 16 questions about preventative measures to avoid cystitis with simple answers divided into "did you know" and "do it yourself"
    • Two questions about ecology,
    • And two other questions about lifestyle and other preventive practices.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Woman aged 18 to 65
Criteria

Inclusion Criteria:

  • Woman aged 18 to 65, consultant in general medicine. (Any patient meeting the inclusion criteria may choose to answer the questionnaire in the waiting room of general practitioners selected by lot.)

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744338


Contacts
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Contact: Lise Laclautre 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Sandra CURINIER         
Sub-Investigator: Patrick NUNES         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Sandra CURINIER University Hospital, Clermont-Ferrand