Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders

NCT02772874 | Completed

• 1 other identifier: 820286
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

fecal incontinence; severity; ultrasound; anorectal manometry; classification

Outcome Measures

Primary Outcomes (1)

• Fecal incontinence severity as measured by mean Vaizey score

  Vaizey score range 0 to 24

  Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.

Secondary Outcomes (4)

• Anal anatomy patency as measured by mean anal sphincter complex thickness (millimeters).

  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.

  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).

  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).

  Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention

Passive-predominant; Urge-predominant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women greater than age 18 with fecal incontinence at least monthly over the last 3 months

You may not qualify if:

• Malignancy
• Fistula
• Rectal prolapse
• Prior colorectal surgery
• Prior radiation
• Fecal impaction
• Sole flatal incontinence
• Neurologic disorders

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Division of Urogynecology

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (7)

• 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.

  PMID: 16012933 BACKGROUND

• Nelson R, Norton N, Cautley E, Furner S. Community-based prevalence of anal incontinence. JAMA. 1995 Aug 16;274(7):559-61.

  PMID: 7629985 BACKGROUND

• 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.

  PMID: 15484348 BACKGROUND

• 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.

  PMID: 24562788 BACKGROUND

• 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.

  PMID: 15307881 BACKGROUND

• Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.

  PMID: 14978634 BACKGROUND

• 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.

  PMID: 29979355 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Avita K Pahwa, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: May 16, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

US (1)