Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section

Objective of this longitudinal observational cohort study was to analyze incidence of pelvic floor dysfunction (PFD) symptoms, including pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI), seven to twelve years after delivery, in two groups of singleton primiparae after vaginal delivery (VD) and cesarean section (CS).

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Key information

Conditions

Pelvic Floor Disorders Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pregnancy Complications Prolapse Rectal Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Observational

About this study

Pelvic floor disorders (PFD) usually refers to three definable groups of symptoms that include pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI). The prevalence of these conditions increases with age, but in general, PFD affect 20-50 % of women throughout their lives. Thus, PFD are common and have significant societal impact. Another important PFD risk factor is childbearing. Specifically, these disorders are more common among multiparas. Vaginal delivery (VD) has been considered the main contributing factor because of pelvic floor muscle, fascia, and nerves damage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

singleton pregnancy
cephalic presentation
delivery in term (gestational week 38-42)
no other childbirth during study period

Exclusion criteria

operative vaginal delivery (vacuum extraction or forceps delivery)

Treatment and study plan

delivery

Behavioral

delivery either vaginal or by cesarean section

Primary outcomes

Pelvic organ prolapse symptoms score

Time frame: seven years after delivery

calculated from validated questionnaire International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

Secondary outcomes

Urinary incontinence symptoms score

Time frame: seven years after delivery

calculated from validated questionnaire Pelvic Organ Prolapse Distress Inventory (POPDI-6)
Fecal incontinence symptoms score

Time frame: seven years after delivery

calculated from validated questionnaire Wexner Fecal Incontinence Score (WS)

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

Pelvic Floor Function Evaluation of Singleton Primiparae After Vaginal Delivery and Cesarean Section: Seven to Twelve-Year Long Observational Cohort Study

Important dates

Study start: 2002
Primary completion: 2007
Study completion: 2014
First posted: Jan 25, 2016
Registry last updated: Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed