Clinical Trial: Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders

Brief Summary: Fecal incontinence (FI) is clinically subtyped as urge FI and passive FI based on symptoms, however the pathophysiologic significance of this subtyping is not known. FI is commonly encountered in women with pelvic floor disorders. This study aims to compare characteristics of clinical severity, quality of life, anatomy, and physiology of urge FI versus passive FI. Urogynecology patients greater than age 18 with FI at least monthly over the last 3 months will be recruited for participation. Participants will be divided into urge FI subtype and passive FI subtype. Participants will complete validated questionnaires on clinical severity and quality of life, both as related to FI and general heath. Participants will undergo pelvic examination, endoanal ultrasound and anorectal manometry for evaluation of anatomic and physiologic pathology. Results between both groups will be compared. The investigators hypothesize that clinical, anatomic, and physiologic characteristics differ between urge-predominant fecal incontinence and passive-predominant fecal incontinence in women with pelvic floor disorders.

Detailed Summary:

Fecal incontinence greatly affects quality of life and can negatively impact an individual's activity level, body image, and likelihood of institutionalization. Female sex and advancing age are known independent risk factors for fecal incontinence. Among community dwelling adults, the prevalence of fecal incontinence has ranged from 0.4 to 18 percent. Prevalence rates of fecal incontinence are even higher in women with pelvic floor disorders, reaching up to 41%, illustrating the large bearing on quality of life of this patient population.

Fecal incontinence can be subtyped into three clinical subtypes: urge fecal incontinence, passive fecal incontinence, and fecal seepage. Urge incontinence refers to loss of fecal matter in spite of active attempts to retain contents; passive incontinence refers to involuntary loss of stool without awareness. Despite the clinical distinction of fecal incontinence subtypes, the pathophysiology of these subtypes is not known. Existing practice guidelines recommend categorizing patients into these subtypes, evaluating symptom severity by patient-reported outcomes, and assessing function of the anorectal complex with imaging and physiologic tests to best tailor management options. Although the framework for subtyping fecal incontinence exists, specific associations between subtypes and clinical, anatomic, and physiologic findings in women with pelvic floor disorders are not well delineated. Further characterizing the subtypes in relation to specific clinical, anatomic, and physiologic findings may allow us to better approach the treatment of women with fecal incontinence.

Our comparison of the two fecal incontinence subtypes, urge-predominant fecal incontinence and passive fecal incontinence, will be evaluated for clinical severity, impact on quality of life, and anatomic and physiologic chara
Sponsor: University of Pennsylvania

Current Primary Outcome: Fecal incontinence severity as measured by mean Vaizey score [ Time Frame: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Anal anatomy patency as measured by mean anal sphincter complex thickness (millimeters). [ Time Frame: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later. ]
  Internal anal sphincter thickness (millimeters) and external anal sphincter thickness (millimeters) at 12, 3, 6, 9 o'clock.
• Anal anatomy patency as measured by presence or absence of defects using endoanal ultrasound. [ Time Frame: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later. ]
  The presence of defects anywhere along internal anal sphincter or external anal sphincter will be measured as present or absent.
• Anal function as measured by the anorectal manometry measurements (see description below). [ Time Frame: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later. ]
  Mean anal resting pressure at high pressure zone (mmHg), mean anal squeeze pressure (mmHg), mean anal squeeze duration (seconds), mean rectal first sensation capacity (cc), mean rectal normal urge capacity (cc), mean rectal strong urge capacity (cc), and mean maximum tolerated volume capacity (cc).
• Rectal function as measured by the anorectal manometry measurements (see description below). [ Time Frame: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later. ]
  Mean rectal first sensation capacity (cc), mean rectal normal urge capacity (cc), mean rectal strong urge capacity (cc), and mean maximum tolerated volume capacity (cc).

Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: February 3, 2015
Date Started: June 2014
Date Completion: December 2016
Last Updated: August 29, 2016
Last Verified: August 2016