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.

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
• ImpactionInhibition 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.

7. History
Fecal Incontinence--Initial Clinic Visit
Onset:
Frequency:
Stool Texture: Bristol Stool Scale
Severity: (Qol)
Subtypes: Passive: Urge: Stress: Overflow: Seepage
Precipitants:

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.

9. Anorectal Manometry
High-Res Manometry Catheter:
• 10 distal sensors
• 2 Proximal sensors
High-Def Manometry Catheter:

10. Resting Pressure
Normal Weak

11. Internal Anal Sphincter Thinning
Normal IAS Thinned IAS

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.

17. SNS Placement

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