An observational study in Fecal Incontinence, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.
Sponsored by University of Pennsylvania · Observational
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.
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:
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 79 observational studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Women greater than age 18 with fecal incontinence at least monthly over the last 3 months being evaluated in the Urogynecology office setting.
Exclusion Criteria:
All subjects who report fecal incontinence that is primarily urge-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry.
Other: 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.
Other: No intervention
No intervention
Fecal incontinence severity as measured by mean Vaizey score
Vaizey score range 0 to 24
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 mean anal sphincter complex thickness (millimeters).
Internal anal sphincter thickness (millimeters) and external anal sphincter thickness (millimeters) at 12, 3, 6, 9 o'clock.
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.
The presence of defects anywhere along internal anal sphincter or external anal sphincter will be measured as present or absent.
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).
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).
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).
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).
Time frame: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
Plan to share: Undecided
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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