Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03744338
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2018-11-14
Brief Title:
Prevention of Cystitis
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Non-antibiotic Primary Prevention of Low Urinary Tract Infections Evaluation of the Knowledge and Practices of Patients in the General Practitioners Office Observational and Descriptive Study in the Former Auvergne Region in France
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
34365000 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
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
Detailed Description:
34365000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None