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Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders (FIST)

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ClinicalTrials.gov Identifier: NCT02772874
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Fecal Incontinence Other: No intervention

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:

  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.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 1, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: 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.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. 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. ]
    Vaizey score range 0 to 24


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women greater than age 18 with fecal incontinence at least monthly over the last 3 months being evaluated in the Urogynecology office setting.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772874


Locations
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United States, Pennsylvania
University of Pennsylvania, Division of Urogynecology
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Avita K Pahwa, MD University of Pennsylvania
Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02772874    
Other Study ID Numbers: 820286
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Pennsylvania:
fecal incontinence
severity
ultrasound
anorectal manometry
classification
Additional relevant MeSH terms:
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Fecal Incontinence
Pelvic Floor Disorders
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pregnancy Complications