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

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.

Anatomy of the Anorectum

Internal Anal Sphincter

(IAS)

External Anal Sphincter

(EAS)

Rectum (Compliance)

Fecal Incontinence Subtypes

FI

Passive

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 gradient

Stress FI

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)

Stool Characteristics

Structural and/or functional

Diagnostic Evaluation

• History

• Physical exam, including digital rectal exam

• Diagnostic tests

Rao SSC et al. Am J Gastroenterol. 2004;99:1585-1604.

HistoryFecal Incontinence--Initial Clinic Visit

Onset:

Frequency:

Stool Texture: Bristol Stool Scale

Severity: (Qol)

Subtypes: Passive: Urge: Stress: Overflow: Seepage

Precipitants:

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.

Anorectal Manometry

High-Res Manometry Catheter:• 10 distal sensors• 2 Proximal sensors

High-Def Manometry Catheter:

Resting Pressure

Normal Weak

Internal Anal Sphincter Thinning

Normal IAS Thinned IAS

Non-pharmacologic Management of Fecal Incontinence

Whitehead WE, Bharucha AE. Gastroenterology. 2010;138:1231-1235.

Intervention Mechanism of Action Side Effects Comments

Incontinence pads

Provides skin protection; prevents soiling; conduct moisture away from skin

Skin irritationDisposable 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

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

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 requiredSolesta [package insert]. Oceana Therapeutics, Edison NJ, 2012. Accessed April 1, 2013 at: http:www.solestainfo.com/pdf/solesta-pi.pdf

Solesta ® Injection Pivotal Trial: Primary Endpoint Data

*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.

Significantly higher responder rates in injection group at 6 months (Responder)*

52%n=136

31%n=70

0

20

40

60

80

Injection Sham

Pro

po

rtio

n r

esp

on

der

s(%

)

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) at12 months (P<.0001)

P=.0089

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.

SNS Placement

Sacral Nerve Stimulation In SSc

Patient 1

Patient 2

Patient 3

Patient 4

Patient 5

0

5

10

15

20

25

Pre-SNSPost-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 hoursMax response time 60 monthsImprovements in urgency, QoLElevations in resting pressures identified

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