Overview

This trial is active, not recruiting.

Condition fecal incontinence
Treatment no intervention
Sponsor University of Pennsylvania
Start date June 2014
End date June 2016
Trial size 21 participants
Trial identifier NCT02772874, 820286

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
All subjects who report fecal incontinence that is primarily urge-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry.
no intervention
No intervention
All subjects who report fecal incontinence that is primarily passive-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry.
no intervention
No intervention

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.
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.
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.
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.

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Women greater than age 18 with fecal incontinence at least monthly over the last 3 months Exclusion Criteria: - Malignancy - Fistula - Rectal prolapse - Prior colorectal surgery - Prior radiation - Fecal impaction - Sole flatal incontinence - Neurologic disorders

Additional Information

Official title Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
Principal investigator Avita K Pahwa, MD
Description 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 characteristics using validated instruments. Primary Aim: To compare the severity of urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders. Secondary Aims: 1. To compare anatomic characteristics in urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders. 2. To compare physiologic characteristics in urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders. 3. To compare quality of life characteristics in urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders. 4. To compare anorectal manometry results and patient preference of testing performed in the left lateral position versus dorsal lithotomy position. Null Hypothesis: Clinical, anatomic, and physiologic characteristics do not differ between urge-predominant fecal incontinence and passive-predominant fecal incontinence in women with pelvic floor disorders.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.