Stress Urinary IncontinenceNCT05845320
Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women
An observational study of Stress Urinary Incontinence, run by Ain Shams University at 1 site in Egypt.
Trial summary
Urinary incontinence (UI) is more common than any other chronic disease. Stress urinary incontinence (SUI), among the various forms of urinary incontinence, is the most prevalent (50%) type of this condition. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- ICIQ-UI SF questionnaire
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2023to Dec 2023
- 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 to 45 years
- Women only
- Adult
Study population: healthy nulligravid females
Who may be able to join
- Women aged between18 and 45 years.
- Non obese females with BMI <25kg/m2.
- Obese females with BMI ≥30kg/m2.
- Nulligravid females.
Who cannot join
- Multiparous Females
- Patients with active urinary tract infection.
- Patients with respiratory or neurological diseases.
- Patients with communication problems, cognitive disorders \& mental disturbance.
- Current treatment with drugs (benzodiazepines, diuretics)
- Patients who underwent any previous abdominal or pelvic surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University maternity hospital
Cairo, Cairo/القاهرة
Maii Nawara, MD, 01001848388, maii_nawara@hotmail.com
About this study
Urinary incontinence (UI) is more common than any other chronic disease. Stress urinary incontinence (SUI), among the various forms of urinary incontinence, is the most prevalent (50%) type of this condition. Female urinary continence is maintained through an integrated function of pelvic floor muscles (PFMs), fascial structures, nerves, supporting ligaments, and the vagina. In women with SUI, the postural activity of the PFMs is delayed, and the balance ability is decreased. Many women, by learning the correct timing of a pelvic floor contraction during a cough, are able to eliminate consequent SUI. Timing is an important function of motor coordination and could be affected by proprioception.
We aim to assess stress urinary incontinence in obese and non-obese Nulligravid females.
- Conditions
- Stress Urinary Incontinence
- Being tested
- ICIQ-UI SF questionnaire
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICIQ-UI SF questionnaireOther
validated arabic short form of ICIQ on urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Obese | BMI>30 Receives: Other: ICIQ-UI SF questionnaire | |
| Non-obesse | BMI<25 Receives: Other: ICIQ-UI SF questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women
as detected by questionnaire score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start14 May 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maii Nawara, MD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845320
- Sponsor's protocol ID
- MS 188/2023
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be available with principal investigator upon request
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women
- ClinicalTrials.gov ID
- NCT05845320
- Acronym / sponsor ID
- MS 188/2023
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 May 2023 (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.
Urinary incontinence (UI) is more common than any other chronic disease. Stress urinary incontinence (SUI), among the various forms of urinary incontinence, is the most prevalent (50%) type of this condition. Female urinary continence is maintained through an integrated function of pelvic floor muscles (PFMs), fascial structures, nerves, supporting ligaments, and the vagina. In women with SUI, the postural activity of the PFMs is delayed, and the balance ability is decreased. Many women, by learning the correct timing of a pelvic floor contraction during a cough, are able to eliminate consequent SUI. Timing is an important function of motor coordination and could be affected by proprioception.
We aim to assess stress urinary incontinence in obese and non-obese Nulligravid females.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Other: ICIQ-UI SF questionnaireBMI>30 |
| Non-obesse | – | Other: ICIQ-UI SF questionnaireBMI<25 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- healthy nulligravid females
Key inclusion criteria (4 listed)
- Women aged between18 and 45 years.
- Non obese females with BMI <25kg/m2.
- Obese females with BMI ≥30kg/m2.
- Nulligravid females.
Key exclusion criteria (6 listed)
- Multiparous Females
- Patients with active urinary tract infection.
- Patients with respiratory or neurological diseases.
- Patients with communication problems, cognitive disorders \& mental disturbance.
- Current treatment with drugs (benzodiazepines, diuretics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICIQ-UI SF questionnairevalidated arabic short form of ICIQ on urinary incontinence | Other | Non-obesse, Obese |
Primary outcome
Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women
Time frame: 6 months
as detected by questionnaire score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Yes. all data will be available with principal investigator upon request
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Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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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.
Maii Nawara, MD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 6 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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Maii Nawara (+201001848388, maii_nawara@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women (time frame: 6 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 30 May 2023.