Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders (FIST)
Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
Study Overview
Detailed 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:
- To compare anatomic characteristics in urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders.
- To compare physiologic characteristics in urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders.
- To compare quality of life characteristics in urge fecal incontinence versus passive fecal incontinence in women with pelvic floor disorders.
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- University of Pennsylvania, Division of Urogynecology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Urge-predominant
All subjects who report fecal incontinence that is primarily urge-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry.
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No intervention
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Passive-predominant
All subjects who report fecal incontinence that is primarily passive-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry.
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Vaizey score range 0 to 24
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Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Internal anal sphincter thickness (millimeters) and external anal sphincter thickness (millimeters) at 12, 3, 6, 9 o'clock.
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Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
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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.
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The presence of defects anywhere along internal anal sphincter or external anal sphincter will be measured as present or absent.
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Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
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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.
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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).
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Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
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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.
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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).
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Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Avita K Pahwa, MD, University of Pennsylvania
Publications and helpful links
General Publications
- Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.
- Bharucha AE, Zinsmeister AR, Locke GR, Seide BM, McKeon K, Schleck CD, Melton LJ. Prevalence and burden of fecal incontinence: a population-based study in women. Gastroenterology. 2005 Jul;129(1):42-9. doi: 10.1053/j.gastro.2005.04.006.
- Nelson R, Norton N, Cautley E, Furner S. Community-based prevalence of anal incontinence. JAMA. 1995 Aug 16;274(7):559-61.
- Macmillan AK, Merrie AE, Marshall RJ, Parry BR. The prevalence of fecal incontinence in community-dwelling adults: a systematic review of the literature. Dis Colon Rectum. 2004 Aug;47(8):1341-9. doi: 10.1007/s10350-004-0593-0.
- Bezerra LR, Vasconcelos Neto JA, Vasconcelos CT, Karbage SA, Lima AC, Frota IP, Rocha AB, Macedo SR, Coelho CF, Costa MK, Souza GC, Regadas SM, Augusto KL. Prevalence of unreported bowel symptoms in women with pelvic floor dysfunction and the impact on their quality of life. Int Urogynecol J. 2014 Jul;25(7):927-33. doi: 10.1007/s00192-013-2317-2. Epub 2014 Feb 22.
- Rao SS; American College of Gastroenterology Practice Parameters Committee. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004 Aug;99(8):1585-604. doi: 10.1111/j.1572-0241.2004.40105.x. No abstract available.
- Pahwa AK, Khanijow KD, Harvie HS, Arya LA, Andy UU. Comparison of Patient Impact and Clinical Characteristics Between Urgency and Passive Fecal Incontinence Phenotypes. Female Pelvic Med Reconstr Surg. 2020 Sep;26(9):570-574. doi: 10.1097/SPV.0000000000000603.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 820286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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