MenopauseNCT03586765
Epidemiology of Urinary Functional Disorders in Women of 40 and More
An observational study of Menopause and Overweight, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Overweight, Surgical Antecedent
- What is being tested?
- Female urinary incontinence
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2017to 31 May 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women of 40 and more
Who may be able to join
- female
- 40 and more
- speaking French
Who cannot join
- men
- female of less than 40
- not speaking French
- refusal
- inability to answer questions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess Prevalence of Urinary Functional Disorders in Women of 40 and More, Visiting a General Practitioner, Occupational Medicine or Health Examination Center in Puy-de-Dôme
Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.
Read the detailed description
The diagnosis of urinary incontinence is clinical. Three types of urinary incontinence are described: urinary stress incontinence, urinary incontinence by overactive bladder or mixed urinary incontinence.
To standardize the medical examination and to precise the urinary incontinence type, the use of a validated questionnaire is recommended (USP), the quality of life's resounding also must be assessing, using questionnaire of quality of life valid in French (ICIQ®, CONTILIFE®…) Several medical cares exist, but patients often don't know it. Unhappily, it is still a taboo subject. In a French medical study, conducted in 1992 by 60 general practitioners, of a total of 2911 female patients, 37% said they had urinary disorders. Among them, 77% said they had symptoms during an effort, 57% had urinary urge incontinence and 35 % had spontaneous leaks. One in five women had three associated disorders.
In a French study conducted in 2005, it appeared that women talked to their general practitioner about urinary disorders only four or five times out of ten, and six times out of ten when they used panty liners.
The results are eloquent, but the data is not recent, and the investigators need some, to propose better cares.
This medical study will be conducted during one month. Two self-filled questionnaires will be distributed by nurses or medical secretary, working at recruited general practitioner's place, to every female patient who will be 40 years old or more, coming for themselves or accompanying somebody else (children for example). Every female patient will have to fill both questionnaires alone, anonymously, and will have to let them in a closed box, in the waiting room.
The two self-filled questionnaires are called USP and CONTILIFE. They are both validated to evaluate symptoms and quality of life.
Additional question about existence of fecal incontinence (and its type), and the reasons why patients didn't talk about it with their general practitioner spontaneously (shame, absence of information about cares, fatality…).
Prior visit of each recruited service by Julie de la Roque, to explain the goals of the study, to general practitioners, nurses and medical secretaries.
- Conditions
- Menopause, Overweight, Surgical Antecedent, Gestity
- Being tested
- Female urinary incontinence
- Keywords
- incontinence, female, observational study, self filled survey, epidemiology
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Female urinary incontinenceOther
Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses. Receives: Other: Female urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
current urinary functional disorders prevalence in women of 40 and more
A difference will be made between urinary stress incontinence and overactive bladder. Each disorder is characterized by a score (not available for patients). The doctor will calculate the score for each one ( from 0 to 9 for urinary stress incontinence, and from 0 to 21 for urinary incontinence by overactive bladder ). A disorder will be considered positive if it is greater than or equal to 1.
Measured: between november 13th, 2017 and december 15th, 2017
Secondary outcomes (5)
Relationship between age and occurrence of functional urinary disorders for same aged groups
question on the self-filled
Measured: between november 13th, 2017 and december 15th, 2017
Relationship between menopause and occurrence of functional urinary disorders for same aged groups
question on the self-filled
Measured: between november 13th, 2017 and december 15th, 2017
Relationship between childbirth way (caesarean or natural way) and occurrence of functional urinary disorders
question on the self-filled
Measured: between november 13th, 2017 and december 15th, 2017
Relationship between carrying of loads within the framework of the occupation and occurrence of functional urinary disorders
question on the self-filled
Measured: between november 13th, 2017 and december 15th, 2017
Relationship between dwelling place and occurrence of functional urinary disorders
question on the self-filled
Measured: between november 13th, 2017 and december 15th, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start13 Nov 2017
- Primary completion31 Dec 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie DE LA ROQUE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586765
- Sponsor's protocol ID
- CHU-395
- Other IDs
- 2017-A00968-45
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess Prevalence of Urinary Functional Disorders in Women of 40 and More, Visiting a General Practitioner, Occupational Medicine or Health Examination Center in Puy-de-Dôme
- ClinicalTrials.gov ID
- NCT03586765
- Acronym / sponsor ID
- CHU-395
- Conditions
- Menopause, Overweight, Surgical Antecedent, Gestity
- Keywords
- incontinence, female, observational study, self filled survey, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 16 Jul 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.
Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.
Detailed description
The diagnosis of urinary incontinence is clinical. Three types of urinary incontinence are described: urinary stress incontinence, urinary incontinence by overactive bladder or mixed urinary incontinence.
To standardize the medical examination and to precise the urinary incontinence type, the use of a validated questionnaire is recommended (USP), the quality of life's resounding also must be assessing, using questionnaire of quality of life valid in French (ICIQ®, CONTILIFE®…) Several medical cares exist, but patients often don't know it. Unhappily, it is still a taboo subject. In a French medical study, conducted in 1992 by 60 general practitioners, of a total of 2911 female patients, 37% said they had urinary disorders. Among them, 77% said they had symptoms during an effort, 57% had urinary urge incontinence and 35 % had spontaneous leaks. One in five women had three associated disorders.
In a French study conducted in 2005, it appeared that women talked to their general practitioner about urinary disorders only four or five times out of ten, and six times out of ten when they used panty liners.
The results are eloquent, but the data is not recent, and the investigators need some, to propose better cares.
This medical study will be conducted during one month. Two self-filled questionnaires will be distributed by nurses or medical secretary, working at recruited general practitioner's place, to every female patient who will be 40 years old or more, coming for themselves or accompanying somebody else (children for example). Every female patient will have to fill both questionnaires alone, anonymously, and will have to let them in a closed box, in the waiting room.
The two self-filled questionnaires are called USP and CONTILIFE. They are both validated to evaluate symptoms and quality of life.
Additional question about existence of fecal incontinence (and its type), and the reasons why patients didn't talk about it with their general practitioner spontaneously (shame, absence of information about cares, fatality…).
Prior visit of each recruited service by Julie de la Roque, to explain the goals of the study, to general practitioners, nurses and medical secretaries.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: Female urinary incontinenceAssess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women of 40 and more
Key inclusion criteria (3 listed)
- female
- 40 and more
- speaking French
Key exclusion criteria (5 listed)
- men
- female of less than 40
- not speaking French
- refusal
- inability to answer questions
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 |
|---|---|---|
| Female urinary incontinenceAssess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses. | Other | Experimental group |
Primary outcome
current urinary functional disorders prevalence in women of 40 and more
Time frame: between november 13th, 2017 and december 15th, 2017
A difference will be made between urinary stress incontinence and overactive bladder. Each disorder is characterized by a score (not available for patients). The doctor will calculate the score for each one ( from 0 to 9 for urinary stress incontinence, and from 0 to 21 for urinary incontinence by overactive bladder ). A disorder will be considered positive if it is greater than or equal to 1.
5 secondary outcomes
Relationship between age and occurrence of functional urinary disorders for same aged groups
Time frame: between november 13th, 2017 and december 15th, 2017
Relationship between menopause and occurrence of functional urinary disorders for same aged groups
Time frame: between november 13th, 2017 and december 15th, 2017
Relationship between childbirth way (caesarean or natural way) and occurrence of functional urinary disorders
Time frame: between november 13th, 2017 and december 15th, 2017
Relationship between carrying of loads within the framework of the occupation and occurrence of functional urinary disorders
Time frame: between november 13th, 2017 and december 15th, 2017
Relationship between dwelling place and occurrence of functional urinary disorders
Time frame: between november 13th, 2017 and december 15th, 2017
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 30 Jul 2018.
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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.
Julie DE LA ROQUE 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 Menopause and Overweight, 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 3 inclusion and 5 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 30 Jul 2018. 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?
current urinary functional disorders prevalence in women of 40 and more (time frame: between november 13th, 2017 and december 15th, 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2018.