Prevalence and Risk Factors for Pelvic Floor Disorders

February 2, 2021 updated by: Sahar MY Elbaradie, Fayoum University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • sahar M.Y elbaradie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • age over 18 years
  • any trimester of pregnancy
  • planned delivery at our institution.

Exclusion Criteria:

  • Women with the inability to complete the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
group A 200 patients
patients with one or more PFDs significant psychological strain in at least one pelvic floor domain
Other: Questionnaire
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.
group B 200 patients
patients without any pelvic floor complaints
Other: Questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fayoum University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • fayoum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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