Clinical trial NCT03586765: Epidemiology of Urinary Functional Disorders in Women of 40 and More
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Overweight
Surgical Antecedent
Gestity
Keywords: incontinence
female
observational study
self filled survey
epidemiology
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 700
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of 40 and more

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* female
* 40 and more
* speaking French

Exclusion Criteria:

* men
* female of less than 40
* not speaking French
* refusal
* inability to answer questions

Primary outcomes:
measure: current urinary functional disorders prevalence in women of 40 and more
timeFrame: between november 13th, 2017 and december 15th, 2017
Secondary outcomes:
measure: Relationship between age and occurrence of functional urinary disorders for same aged groups
timeFrame: between november 13th, 2017 and december 15th, 2017
measure: Relationship between menopause and occurrence of functional urinary disorders for same aged groups
timeFrame: between november 13th, 2017 and december 15th, 2017
measure: Relationship between childbirth way (caesarean or natural way) and occurrence of functional urinary disorders
timeFrame: between november 13th, 2017 and december 15th, 2017
measure: Relationship between carrying of loads within the framework of the occupation and occurrence of functional urinary disorders
timeFrame: between november 13th, 2017 and december 15th, 2017
measure: Relationship between dwelling place and occurrence of functional urinary disorders
timeFrame: between november 13th, 2017 and december 15th, 2017
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Julie DE LA ROQUE
role: PRINCIPAL_INVESTIGATOR
References: