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Epidemiology of Urinary Functional Disorders in Women of 40 and More

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ClinicalTrials.gov Identifier: NCT03586765
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment
Menopause Overweight Surgical Antecedent Gestity Other: Female urinary incontinence

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 Type : Observational
Actual Enrollment : 700 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Female urinary incontinence
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women of 40 and more
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586765


Locations
France
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Julie DE LA ROQUE University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03586765     History of Changes
Other Study ID Numbers: CHU-395
2017-A00968-45 ( Other Identifier: 2017-A00968-45 )
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
incontinence
female
observational study
self filled survey
epidemiology

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms