Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
NCT ID: NCT02772874
Last Updated: 2017-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2014-06-30
2016-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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.
No intervention
No intervention
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.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Fistula
* Rectal prolapse
* Prior colorectal surgery
* Prior radiation
* Fecal impaction
* Sole flatal incontinence
* Neurologic disorders
18 Years
FEMALE
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Avita K Pahwa, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania, Division of Urogynecology
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.
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.
Other Identifiers
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820286
Identifier Type: -
Identifier Source: org_study_id
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