NCT03386292

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

December 16, 2017

Last Update Submit

December 20, 2017

Conditions

Keywords

prevalenceurinary incontinenceanal incontinencerisk factorswomen

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 month

  • 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).

    1 month

Secondary Outcomes (1)

  • Risk factors for urinary and anal incontinence

    1 month

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medecine

Monastir, 5019, Tunisia

Location

MeSH Terms

Conditions

Urinary IncontinenceEncopresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 16, 2017

First Posted

December 29, 2017

Study Start

June 16, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations