Fecal IncontinenceFISTNCT02772874
Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
An observational study of Fecal Incontinence, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 1 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Women greater than age 18 with fecal incontinence at least monthly over the last 3 months
Who cannot join
- Malignancy
- Fistula
- Rectal prolapse
- Prior colorectal surgery
- Prior radiation
- Fecal impaction
- Sole flatal incontinence
- Neurologic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Division of Urogynecology
Philadelphia, Pennsylvania, 19106
About this study
Official title: Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- No intervention
- Keywords
- fecal incontinence, severity, ultrasound, anorectal manometry, classification
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal incontinence severity as measured by mean Vaizey score
Vaizey score range 0 to 24
Measured: 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).
Internal anal sphincter thickness (millimeters) and external anal sphincter thickness (millimeters) at 12, 3, 6, 9 o'clock.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Participants will be assessed for this outcome at their sole primary visit and data will be presented approximately 1 year later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avita K Pahwa, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772874
- Sponsor's protocol ID
- 820286
- Acronym
- FIST
- Status last verified
- Aug 2017
- First submitted
- 3 Feb 2015
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16012933Nelson R, Norton N, Cautley E, Furner S. Community-based prevalence of anal incontinence. JAMA. 1995 Aug 16;274(7):559-61.
PubMed 7629985Macmillan 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.
PubMed 15484348Bezerra 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.
PubMed 24562788Rao 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.
PubMed 15307881Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.
PubMed 14978634Pahwa 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.
PubMed 29979355
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Anatomic, and Physiologic Characteristics of Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT02772874
- Acronym / sponsor ID
- FIST / 820286
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, severity, ultrasound, anorectal manometry, classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urge-predominant | – | Other: No interventionAll subjects who report fecal incontinence that is primarily urge-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry. |
| Passive-predominant | – | Other: No interventionAll subjects who report fecal incontinence that is primarily passive-predominant will undergo self-administered questionnaires, pelvic examination, endoanal ultrasound, and anorectal manometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women greater than age 18 with fecal incontinence at least monthly over the last 3 months
Key exclusion criteria (8 listed)
- Malignancy
- Fistula
- Rectal prolapse
- Prior colorectal surgery
- Prior radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Passive-predominant, Urge-predominant |
Primary outcome
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
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Background: PubMed 16012933Bharucha 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.
- Background: PubMed 7629985Nelson R, Norton N, Cautley E, Furner S. Community-based prevalence of anal incontinence. JAMA. 1995 Aug 16;274(7):559-61.
- Background: PubMed 15484348Macmillan 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.
- Background: PubMed 24562788Bezerra 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.
- Background: PubMed 15307881Rao 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.
- Background: PubMed 14978634Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.
- Derived from this study: PubMed 29979355Pahwa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avita K Pahwa, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772874, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.