Urinary IncontinenceNCT06352879
Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq.
An observational study of Urinary Incontinence and Urge Incontinence, run by Al-Kindy College of Medicine at 2 sites in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urge Incontinence, Stress Incontinence
- How many people
- 384 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Mar 2024to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women attending primary healthcare centers in Baghdad, Iraq
Who may be able to join
- women
- Attending the primary healthcare centers in Baghdad, Iraq
- older than 18 years
Who cannot join
- Patients who refuse to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites, 2 recruiting
- Recruiting
Baghdad Al- Karkh Health Directorate
Baghdad
Harth Mohamed Kamber, FICMS (Uro.), 009647706029071, harthkamber@kmc.uobaghdad.edu.iq
Shahad Hameed Kadhom, MBChB
- Recruiting
Baghdad Al-Russafa Health Directorate
Baghdad
Harth Mohamed Kamber, FICMS (Uro.), 009647706029071, harthkamber@kmc.uobaghdad.edu.iq
Shahad Hameed Kadhom, MBChB
About this study
Official title: Prevalence, Types and Risk Factors of Urinary Incontinence Among Women Attending Primary Healthcare Centers in Baghdad, Iraq.
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.
- Conditions
- Urinary Incontinence, Urge Incontinence, Stress Incontinence
- Keywords
- Urinary Incontinence, Urge incontinence, Stress incontinence, Mixed incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Urge, Urinary Incontinence, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Risk factors for urinary incontinence
the study aim to study 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Mar 2024
- Primary completion31 May 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harth Mohamed Kamber, FICMS (Uro.), Study chair, University of Baghdad / Alkindy collage of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352879
- Sponsor's protocol ID
- 18-Al-KindyCM
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Types and Risk Factors of Urinary Incontinence Among Women Attending Primary Healthcare Centers in Baghdad, Iraq.
- ClinicalTrials.gov ID
- NCT06352879
- Acronym / sponsor ID
- 18-Al-KindyCM
- Conditions
- Urinary Incontinence, Urge Incontinence, Stress Incontinence
- Keywords
- Urinary Incontinence, Urge incontinence, Stress incontinence, Mixed incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women attending primary healthcare centers in Baghdad, Iraq
Key inclusion criteria (3 listed)
- women
- Attending the primary healthcare centers in Baghdad, Iraq
- older than 18 years
Key exclusion criteria (1 listed)
- Patients who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF)
Time frame: 3 months
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.
1 secondary outcome
Risk factors for urinary incontinence
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harth Mohamed Kamber, FICMS (Uro.) study chair
University of Baghdad / Alkindy collage of medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Urge Incontinence, run by Al-Kindy College of Medicine at 2 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harth Mohamed Kamber, FICMS (Uro.) (07706029071, harthkamber@kmc.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.