Prevalence and Risk Factors for Pelvic Floor Disorders

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: Completed
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Other: Questionnaire

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: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	one year

Collaborators and Investigators

• Sponsor: Fayoum University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID 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