Pelvic Floor DisordersNCT04185376
Prevalence and Risk Factors for Pelvic Floor Disorders
An observational study of Pelvic Floor Disorders, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Pelvic floor disorders (PFD) can adversely affect the quality of life of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2019to 10 Dec 2020
- 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 40 years
- Women only
- Adult
Study population: Women ran through the questionnaire either during their first or last visit at the outpatient clinic and afterwards they were classified into two groups: patients with one or more PFDs (n = 96/200) (= significant psychological strain in at least one pelvic floor domain) and patients without any pelvic floor complaints (n = 104/200). Clinical information, including obstetrical and neonatal data
Who may be able to join
- age over 18 years
- any trimester of pregnancy
- planned delivery at our institution.
Who cannot join
- Women with the inability to complete the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Risk Factors for Pelvic Floor Disorders During Pregnancy in a Cohort of Egyptian Women
Pelvic floor disorders (PFD) can adversely affect the quality of life of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFD and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention.
Read the detailed description
Pelvic floor disorders (PFDs) can adversely affect the quality of life (QoL) of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. The reported prevalence of PFDs varies widely both during and after pregnancy and reported up to 30-50%. Besides, the term PFD includes a broad spectrum of conditions such as urinary incontinence (UI), pelvic organ prolapse (POP) or anal incontinence (AI). Many risk factors seem to be involved like the pregnancy itself, mode of delivery, parity, the use of episiotomy, obesity, increased age and so on. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFDs and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. The identification of women during their pregnancy who are at higher risk for PFD remains a key element in targeting of prevention and planning health of resource allocation strategies. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention. The validated German pelvic floor questionnaire modified for pregnancy and postpartum period is thus an important tool identifying such symptoms and helping clinicians assess patient's quality of life. The aim of the present study was to evaluate the prevalence of PFDs in a cohort of Egyptian women during pregnancy. Furthermore, we searched for clinical risk factors that correlate with the occurrence of PFDs during pregnancy in the investigator's population.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Questionnaire
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
a self-administered questionnaire for the assessment of pelvic floor disorders, their risk factors and their impact of quality of life during pregnancy and postpartum period which integrates bladder, bowel and sexual function, pelvic organ prolapse, severity, bothersomeness and conditions specific quality of life in women with urinary incontinence (UI) and/or POP. The questionnaire is divided into four main domains (bladder, bowel, pelvic organ prolapse, sexual function) and each question is scored from zero to three. The additive scores are divided by the maximum reachable score and multiplied by ten, giving a value between zero (0 = no symptoms) and ten (10 = maximum symptoms) for each of the domains.
| Study group | Role | What they receive |
|---|---|---|
| group A 200 patients | patients with one or more PFDs significant psychological strain in at least one pelvic floor domain Receives: Other: Questionnaire | |
| group B 200 patients | patients without any pelvic floor complaints Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective pelvic floor-related quality of life symptoms.
the prevalence of pelvic floor disorders during pregnancy and the clinical risk factors which correlate with pelvic floor symptoms during pregnancy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start15 Dec 2019
- Primary completion30 Nov 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar MY Elbaradie, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185376
- Sponsor's protocol ID
- fayoum
- Status last verified
- Feb 2021
- First submitted
- 30 Nov 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors for Pelvic Floor Disorders During Pregnancy in a Cohort of Egyptian Women
- ClinicalTrials.gov ID
- NCT04185376
- Acronym / sponsor ID
- fayoum
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 4 Dec 2019 (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.
Pelvic floor disorders (PFD) can adversely affect the quality of life of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFD and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention.
Detailed description
Pelvic floor disorders (PFDs) can adversely affect the quality of life (QoL) of a woman and they can occur during different stages of female life such as during pregnancy, early postpartum period or during menopause. The reported prevalence of PFDs varies widely both during and after pregnancy and reported up to 30-50%. Besides, the term PFD includes a broad spectrum of conditions such as urinary incontinence (UI), pelvic organ prolapse (POP) or anal incontinence (AI). Many risk factors seem to be involved like the pregnancy itself, mode of delivery, parity, the use of episiotomy, obesity, increased age and so on. It is well known that pregnancy and vaginal birth are significant risk factors in the etiology of PFDs and predicting models like UR-CHOICE score were developed for this reason to provide mothers-to-be with sufficient information regarding their subsequent risk of PFD. The identification of women during their pregnancy who are at higher risk for PFD remains a key element in targeting of prevention and planning health of resource allocation strategies. Pregnancy, childbirth and the immediate postpartum period, where the demands on the pelvic floor and the incidence of pelvic floor trauma are particularly high, offers an optimal opportunity for such counseling and prevention. The validated German pelvic floor questionnaire modified for pregnancy and postpartum period is thus an important tool identifying such symptoms and helping clinicians assess patient's quality of life. The aim of the present study was to evaluate the prevalence of PFDs in a cohort of Egyptian women during pregnancy. Furthermore, we searched for clinical risk factors that correlate with the occurrence of PFDs during pregnancy in the investigator's population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A 200 patients | – | Other: Questionnairepatients with one or more PFDs significant psychological strain in at least one pelvic floor domain |
| group B 200 patients | – | Other: Questionnairepatients without any pelvic floor complaints |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women ran through the questionnaire either during their first or last visit at the outpatient clinic and afterwards they were classified into two groups: patients with one or more PFDs (n = 96/200) (= significant psychological strain in at least one pelvic floor domain) and patients without any pelvic floor complaints (n = 104/200). Clinical information, including obstetrical and neonatal data
Key inclusion criteria (3 listed)
- age over 18 years
- any trimester of pregnancy
- planned delivery at our institution.
Key exclusion criteria (1 listed)
- Women with the inability to complete the questionnaire
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 |
|---|---|---|
| Questionnairea self-administered questionnaire for the assessment of pelvic floor disorders, their risk factors and their impact of quality of life during pregnancy and postpartum period which integrates bladder, bowel and sexual function, pelvic organ prolapse, severity, bothersomeness and conditions specific quality of life in women with urinary incontinence (UI) and/or POP. The questionnaire is divided into four main domains (bladder, bowel, pelvic organ prolapse, sexual function) and each question is scored from zero to three. The additive scores are divided by the maximum reachable score and multiplied by ten, giving a value between zero (0 = no symptoms) and ten (10 = maximum symptoms) for each of the domains. | Other | group A 200 patients, group B 200 patients |
Primary outcome
subjective pelvic floor-related quality of life symptoms.
Time frame: one year
the prevalence of pelvic floor disorders during pregnancy and the clinical risk factors which correlate with pelvic floor symptoms during pregnancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pelvic Floor Disorders, run by Fayoum University Hospital 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 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: finished, as of the sponsor's last update on 3 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective pelvic floor-related quality of life symptoms. (time frame: one year). 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 3 Feb 2021.