Woman Aged 18 to 65NCT03744338
Prevention of Cystitis.
An observational study of Woman Aged 18 to 65, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Woman Aged 18 to 65
- What is being tested?
- questionnaire
- How many people
- 773 participants
- Where
- 1 siteFrance
- Study dates
- 14 Aug 2018to 25 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Woman aged 18 to 65
Who may be able to join
- 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.)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Woman Aged 18 to 65
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patients' knowledge and behaviors on means of prevention of cystitis from responses to questionnaire items
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.
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start14 Aug 2018
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Woman Aged 18 to 65Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra CURINIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744338
- Sponsor's protocol ID
- CHU-416
- Status last verified
- Jun 2020
- First submitted
- 14 Nov 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Francois M, Hanslik T, Dervaux B, Le Strat Y, Souty C, Vaux S, Maugat S, Rondet C, Sarazin M, Heym B, Coignard B, Rossignol L. The economic burden of urinary tract infections in women visiting general practices in France: a cross-sectional survey. BMC Health Serv Res. 2016 Aug 9;16(a):365. doi: 10.1186/s12913-016-1620-2.
PubMed 27507292Kunin CM. Urinary tract infections in females. Clin Infect Dis. 1994 Jan;18(1):1-10; quiz 11-2. doi: 10.1093/clinids/18.1.1. No abstract available.
PubMed 8054415Arpin C, Quentin C, Grobost F, Cambau E, Robert J, Dubois V, Coulange L, Andre C; Scientific Committee of ONERBA. Nationwide survey of extended-spectrum beta-lactamase-producing Enterobacteriaceae in the French community setting. J Antimicrob Chemother. 2009 Jun;63(6):1205-14. doi: 10.1093/jac/dkp108. Epub 2009 Mar 28.
PubMed 19329798
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03744338
- Acronym / sponsor ID
- CHU-416
- Conditions
- Woman Aged 18 to 65
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: questionnaire |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Woman aged 18 to 65
Key inclusion criteria (1 listed)
- 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.)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireThe 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. | Other | Group 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 27507292Francois M, Hanslik T, Dervaux B, Le Strat Y, Souty C, Vaux S, Maugat S, Rondet C, Sarazin M, Heym B, Coignard B, Rossignol L. The economic burden of urinary tract infections in women visiting general practices in France: a cross-sectional survey. BMC Health Serv Res. 2016 Aug 9;16(a):365. doi: 10.1186/s12913-016-1620-2.
- Background: PubMed 8054415Kunin CM. Urinary tract infections in females. Clin Infect Dis. 1994 Jan;18(1):1-10; quiz 11-2. doi: 10.1093/clinids/18.1.1. No abstract available.
- Background: PubMed 19329798Arpin C, Quentin C, Grobost F, Cambau E, Robert J, Dubois V, Coulange L, Andre C; Scientific Committee of ONERBA. Nationwide survey of extended-spectrum beta-lactamase-producing Enterobacteriaceae in the French community setting. J Antimicrob Chemother. 2009 Jun;63(6):1205-14. doi: 10.1093/jac/dkp108. Epub 2009 Mar 28.
Related trials for Woman Aged 18 to 65
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra CURINIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Woman Aged 18 to 65, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of patients' knowledge and behaviors on means of prevention of cystitis from responses to questionnaire items (time frame: at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744338, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.