Prevalence and Risk Factors for Pelvic Floor Disorders

NCT04185376 | Completed DMC

• 1 other identifier: fayoum
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group A 200 patients

patients with one or more PFDs significant psychological strain in at least one pelvic floor domain

Other: Questionnaire

group B 200 patients

patients without any pelvic floor complaints

Other: Questionnaire

Interventions

Questionnaire OTHER

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 A 200 patients; group B 200 patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Women with the inability to complete the questionnaire

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

sahar M.Y elbaradie

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate Professor

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 4, 2019
• Study Start: December 15, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 10, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

EG (1)