Fecal incontinence is more prevalent in patients with scleroderma compared to the general population. It can be caused by structural abnormalities of the internal and external anal sphincters as well as neurological and stool abnormalities. Diagnostic tests like anorectal manometry and endoanal ultrasound can identify abnormalities. Treatment options include lifestyle modifications, biofeedback, bulking agents, sacral nerve stimulation, and surgery. However, no treatment has been proven highly effective for fecal incontinence in scleroderma patients.
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Fecal Incontinence: A Primer for Individuals with Scleroderma
1. Northwestern University Feinberg School of Medicine
Fecal Incontinence: A Primer for
Individuals with Scleroderma
Darren M. Brenner, MD
Assistant Professor of Medicine and Surgery
Northwestern University—Feinberg School of Medicine
2. Prevalence of Fecal Incontinence:
General Population Versus Scleroderma
Overall prevalence of
fecal incontinence: 9.0%1
Prevalence in patients with
scleroderma (SSc)
22-38%2,3
*Data from NHANES 2005/2006 and 2009/2010 surveys. N=52,195.
Ditah I et al. Am J Gastroenterol. 2012;107:S717. Abstract 1762.; Omair and Lee. J Rheumatol 2013;39:992-6.;
Trezza.Scand J Gastroenterol 1999;34;409-13.
3. Anatomy of the Anorectum
Internal Anal Sphincter
(IAS)
External Anal Sphincter
(EAS)
Rectum (Compliance)
4. Fecal Incontinence Subtypes
Passive
FI
Overflow
Urge
Stress
• Unconscious loss of stool
• Primarily related to IAS
dysfunction
Passive FI
• Secondary to constipation/fecal
impaction
• ImpactionInhibition of IAS tone
Overflow
FI
• Conscious knowledge of stool loss
with inability to control
• Primarily related to EAS
dysfunction
Urge FI
• Uncommon and a/w (+) recto-anal
Stress FI gradient
5. Common Deficiencies Identified in SSc Patients
• Loss of RAIR
• Decreased Anal Sensation
•Thinning of the IAS
• Fibrosis of the IAS
• Decreased Anal Pressure
• Diarrhea/ Constipation
Thoua et al. AJG 1012:107:597-603. Thoua et al. Rheumatology 2011;50(9):1596-602.
Fynne et al. Scand J Rheumatol 2011;40(6):462-66. Koh et al. Dis Colon Rectum 2009;52(2):315-18.
Indicative of
Neuropathy (Functional)
Indicative of
Myopathy (Structural)
Structural and/or
functional
Stool Characteristics
6. Diagnostic Evaluation
• History
• Physical exam, including digital rectal exam
• Diagnostic tests
Rao SSC et al. Am J Gastroenterol. 2004;99:1585-1604.
8. Diagnostic Testing
Physiologic
Test
Measurements Evidence
Anorectal
manometry1
Quantifies sphincter
pressures, sensation, rectal
compliance and recto-anal
reflexes
Good
Endoanal
ultrasound
Assesses IAS and EAS
thickness, integrity
Good
Surface
EMG1 Provides information on
normal or weak tone
Fair
Adapted from: Rao SSC. Clin Gastroenterol Hepatol. 2010;8:910-919.
12. Non-pharmacologic Management of
Fecal Incontinence
Intervention Mechanism of Action Side Effects Comments
Incontinence
pads
Provides skin protection;
prevents soiling; conduct
moisture away from skin
Skin irritation
Whitehead WE, Bharucha AE. Gastroenterology. 2010;138:1231-1235.
Disposable provides better
skin protection than
nondisposable
Enemas
Evacuates rectum, decreasing
likelihood of FI
Inconvenient; side
effects from
specific
preparations
Anorectal
biofeedback
Improves rectal sensation;
coordinates external anal
sphincter contraction; may
increase anal sphincter tone
None
Success is more likely if the
patient is motivated, with
intact cognition, absense of
depression, and with some
rectal sensation; availability
and cost can be
problematic
13. Pharmacologic Management of
Fecal Incontinence
• Antidiarrheals
•Tricyclic antidepressants
• Bile acid binding resins
No pharmacologic treatments have been adequately evaluated in large,
randomized, controlled studies in patients with fecal incontinence
No pharmacologic treatments have been evaluated in controlled studies in
Scleroderma patients with fecal incontinence
14. Injectable Gel Treatment for FI
• Biocompatible gel of dextranomer
microspheres in hyaluronic acid
• FDA-approved for the treatment of
fecal incontinence in patients aged ≥18
years who have failed conservative
therapy
• Administration
• Done in physician office or hospital
outpatient department
• Four injections through an anoscope
• Injected into submucosal layer of the
anal canal
• No anesthesia required
Solesta [package insert]. Oceana Therapeutics, Edison NJ, 2012. Accessed April 1, 2013 at: http:www.solestainfo.com/pdf/solesta-pi.pdf
15. Solesta ® Injection Pivotal Trial:
Primary Endpoint Data
Significantly higher responder rates in injection
group at 6 months (Responder)*
52%
n=136
80
60
40
20
*Responder = ≥50% reduction in incontinence episodes as compared with baseline.
Graf W et al on behalf of the NASHA Dx Study Group. Lancet. 2011; 377: 997–1003.
31%
n=70
0
Injection Sham
Median number of
incontinence episodes
during 2 weeks in the
active treatment group
decreased from 15.0
(IQR 9.6–27.5) at baseline
to 6.2 (2.0–15.5) at
12 months (P<.0001)
P=.0089
16. Sacral Nerve Stimulation System
1. Tined lead is placed parallel
to the sacral (S2, S3, or S4)
nerve
2. Implantable
neurostimulator generates
mild electrical pulses that
are delivered through the
lead electrodes
3. Clinician and patient
programmers are used to
set the parameters of the
electrical pulses
1
2
3
InterStim II Neuromodulator [manual]. Medtronic, Inc. Minneapolis, MN. 2012.
18. Sacral Nerve Stimulation In SSc
25
20
15
10
5
0
Pre-SNS
Post-SNS
• 5 women
• All failed conventional
therapy
• Liquid and solid stool
• Median # weekly FI
episodes=15
• Duration SSc=13 yrs
• Duration FI=5 years
Kenefick et al. Gut 2002;51:81-83
Weekly Incontinent Episodes
Patient 5: lead displdged in 1st 24 hours
Max response time 60 months
Improvements in urgency, QoL
Elevations in resting pressures identified
19. Summary
FI is a common and debilitating disorder
Due to anatomical/functional pelvic floor
abnormalities and changes in stool characteristics
Types: Passive, Urge, Overflow, Stress
Diagnostics: ARM and US primary studies
Therapeutics: None a panacea but rapidly
improving outcomes
Notas del editor
Good Morning L&G. I want to thank you and my colleagues for allowing me to speak to you this AM. I am a Gastroenterologist and thus find this to be a unique experience affording me the opportunity to discuss treatments of OIC with the pain community. My goal is provide you with a general overview of what is currently available, some of what I believe may be coming down the pipeline and my general gestalt for treating patients with this disorder.
The prevalence of fecal incontinence is surprisingly high. A study conducted by Ditah and colleagues using data from National Health and Nutrition Examination Survey (N=52,195) found that:
The overall prevalence of fecal incontinence was 9.01% (2009-2010 survey)
Fecal incontinence occurred at least weekly in 1.13% of participants in survey
Prevalence is similar in women (9.13%) and men (7.36%)
Among individuals ≥70 years old, prevalence is 17.5%
ADDITIONAL INFORMATION
NHANES assesses health status in the civilian non-institutionalized US population. The validated Fecal Incontinence Severity Index was added to NHANES since 2005/2006 survey. Data for this study was collected from the year 2005 to 2010. Participants included men and women aged ≥20 years
Fecal incontinence was defined as accidental leakage of solid, liquid or mucus at least once in the preceding monthThe study included 52,195 participants, in whom the estimated overall prevalence of FI was 9.01% in the 2009/2010 survey
Of note, the prevalence of fecal incontinence increased from 6.96% in 2005/2006 to 9.01% in 2009/2010—an increase that was statistically significant
Use this model because the one I use in clinic. There are much more anatomically specific images I coulkd have used but this may be similar to the ones you have access to and will make it easier to engage with patients
SO based on all of this information when we try to categorize her FI, what types of FI might she be suffering from? Talk about 4 different subtypes
The diagnostic evaluation includes a detailed history, a physical exam (including digital rectal exam), and one or more diagnostic examinations
This slide serves as an outline for the next section. Each of these topics will be covered in detail
This slide provides a brief overview of nonpharmacologic modalities for managing fecal incontinence
Beyond managing the underlying disease state (if identified), a number of pharmacologic treatments may provide benefit in patients with fecal incontinence. However, it is important to note that none of these therapies have been adequately evaluated in large, randomized, controlled studies in patients with fecal incontinence.
In this randomized, double-blind, sham-controlled trial, patients aged 18–75 years from centers in USA and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomization was stratified by sex and region in blocks of six, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of fecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by ≥50%.
278 patients were screened for inclusion, of whom 206 were randomized assigned to receive NASHA Dx (n=136) or sham treatment (n=70).
71 patients who received NASHA Dx (52%) had a 50% or more reduction in the number of incontinence episodes, compared with 22 patients who received sham treatment (31%; odds ratio 2·36, 95% CI 1·24–4·47, p=0·0089). We recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess)
This slide shows the InterStim system, a sacral nerve stimulation system for the management of fecal incontinence
A tined lead is placed paralel to the sacral (S2, S3, or S4) nerve
An implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes
Clinician and patient programmers are used to set the parameters of the electrical pulses