NCT06352879

Brief Summary

The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:

  • What is the prevalence of incontinence among the targeted group?
  • What are the types of incontinence and what is the frequency of each type among the targeted group?
  • What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

March 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 3, 2024

Last Update Submit

April 3, 2024

Conditions

Keywords

Urinary IncontinenceUrge incontinenceStress incontinenceMixed incontinence

Outcome Measures

Primary Outcomes (1)

  • Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF)

    Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) consists of three-scored items designed to evaluate the frequency of urine leaks (score 0-5), the amount of leaked urine (score 0-6), and the effect urine leakage on the quality of life of the participant (score 0-10). In addition, an unscored item to evaluate the sensed causes of leakage. The scores of the scored items are added together to provide a total score, which ranges from zero to 21. The higher the score, the more severe the urine leakage.

    3 months

Secondary Outcomes (1)

  • Risk factors for urinary incontinence

    3 months

Eligibility Criteria

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

Adult women attending primary healthcare centers in Baghdad, Iraq

You may qualify if:

  • women
  • Attending the primary healthcare centers in Baghdad, Iraq
  • older than 18 years

You may not qualify if:

  • Patients who refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baghdad Al- Karkh Health Directorate

Baghdad, Iraq

RECRUITING

Baghdad Al-Russafa Health Directorate

Baghdad, Iraq

RECRUITING

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, UrgeUrinary Incontinence, Stress

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 Symptoms

Study Officials

  • Harth Mohamed Kamber, FICMS (Uro.)

    University of Baghdad / Alkindy collage of medicine

    STUDY CHAIR

Central Study Contacts

Harth Mohamed Kamber, FICMS (Uro.)

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 8, 2024

Study Start

March 1, 2024

Primary Completion

May 31, 2024

Study Completion

June 15, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations