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

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 Overview

• Status: Completed
• Conditions: Overweight; Menopause; Surgical Antecedent; Gestity
• Intervention / Treatment: 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
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women of 40 and more

Description

Inclusion Criteria:

• female
• 40 and more
• speaking French

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between november 13th, 2017 and december 15th, 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between age and occurrence of functional urinary disorders for same aged groups	question on the self-filled	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	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	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	between november 13th, 2017 and december 15th, 2017
Relationship between dwelling place and occurrence of functional urinary disorders	question on the self-filled	between november 13th, 2017 and december 15th, 2017

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Julie DE LA ROQUE, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: epidemiology; observational study; female; incontinence; self filled survey
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: CHU-395; 2017-A00968-45 (Other Identifier: 2017-A00968-45)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No