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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: Brno University Hospital

Current Primary Outcome: Pelvic organ prolapse symptoms score [ Time Frame: seven years after delivery ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: Brno University Hospital

Dates:
Date Received: January 16, 2016
Date Started: January 2002
Date Completion:
Last Updated: January 22, 2016
Last Verified: January 2016