Woman Aged 18 to 65 Clinical Trial
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.
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.
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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