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Completed

NCT Number: NCT03586765

Epidemiology of Urinary Functional Disorders in Women of 40 and More

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • 40 and more
  • speaking French

Exclusion criteria

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

Treatment and study plan

Female urinary incontinence

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relationship between age and occurrence of functional urinary disorders for same aged groups

    Time frame: between november 13th, 2017 and december 15th, 2017

    question on the self-filled

  2. Relationship between menopause and occurrence of functional urinary disorders for same aged groups

    Time frame: between november 13th, 2017 and december 15th, 2017

    question on the self-filled

  3. Relationship between childbirth way (caesarean or natural way) and occurrence of functional urinary disorders

    Time frame: between november 13th, 2017 and december 15th, 2017

    question on the self-filled

  4. 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

    question on the self-filled

  5. Relationship between dwelling place and occurrence of functional urinary disorders

    Time frame: between november 13th, 2017 and december 15th, 2017

    question on the self-filled

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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