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CompletedNCT03386292Updated Dec 29, 2017

Urinary and Anal Incontinence in Tunisian Women

An observational study in Woman, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by University of Monastir · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years and older
Sex
Female
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Study summary

The publications on prevalence and risk factors of urinary and anal incontinence in women were performed mainly in Europe and America. Consequently, result extrapolation to Tunisian population may not be a good practice which justifies this study and demonstrates its importance.

Read the detailed description

A cross-sectional study will be conducted among female doctors and nurses randomly selected from 3 large hospitals in the center of Tunisia. The prevalence of urinary incontinence and anal incontinence will be measured using validated questionnaires.

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Conditions studied

  • Woman

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Keywords

  • prevalence
  • urinary incontinence
  • anal incontinence
  • risk factors
  • women
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Female doctors and nurses working at Sahloul Hospital, Taher Sfar Hospital and Fattouma Bourguiba Hospital

Inclusion criteria

  • Professional seniority in the current service over than 6 months
  • Subject has given his consent

Exclusion criteria

Exclusion Criteria:

  • Resident
  • Intern
  • An ongoing pregnancy
  • A recent birth (less than 6 months)
  • A psychiatric disease
  • An acute or chronic kidney disease
  • Neurological disease
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Prevalence of urinary incontinence

    The participant will be asked to fill out the urinary symptom profile questionnaire (USP). This questionnaire contains 13 items to assess stress urinary incontinence, urge urinary incontinence and dysuria. Each question is scored from 0 to 3 providing a maximal score of 9, 21 and 9 for stress urinary incontinence, urge urinary incontinence and dysuria respectively. Women diagnosed with both stress and urge urinary incontinence by the USP were classified as having mixed urinary incontinence.

    Time frame: 1 month

  2. Prevalence of anal incontinence

    The participant will be asked to fill out the anal incontinence Jorge and Wexner which contains five questions scored on a scale from zero (normal continence) to 20 (total incontinence).

    Time frame: 1 month

Secondary outcomes

  1. Risk factors for urinary and anal incontinence

    Time frame: 1 month

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Study locations

1 site
  • Faculty of Medecine
    Monastir, 5019, Tunisia
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Registry details

Key details

Study ID
NCT03386292
Lead sponsor
University of Monastir
Responsible party
Syrine GALLAS (Principal investigator, University of Monastir) — Principal investigator
First posted
Dec 29, 2017
Start date
Jun 16, 2017
Primary completion
Sep 30, 2017
Completion
Sep 30, 2017
Last update
Dec 29, 2017
View the source record on ClinicalTrials.gov ↗

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