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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

Tracking Information
First Submitted Date November 14, 2018
First Posted Date November 16, 2018
Last Update Posted Date February 4, 2019
Actual Study Start Date August 14, 2018
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03744338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevention of Cystitis.
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.
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.

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Woman aged 18 to 65
Condition Woman Aged 18 to 65
Intervention 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.

Study Groups/Cohorts Group 1
Intervention: Other: questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 14, 2018)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2019
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lise Laclautre 04 73 75 49 63 drci@chu-clermontferrand.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03744338
Other Study ID Numbers CHU-416
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators
Principal Investigator: Sandra CURINIER University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date February 2019