Northwestern University Feinberg School of Medicine

Fecal Incontinence in the Scleroderma Patient:
What We Know and Where...
Prevalence of Fecal Incontinence:
General Population Versus Scleroderma
Overall prevalence of
fecal incontinence:

9.0%1

...
Fecal Incontinence Has a Profound Impact
on Quality of Life
FI patients

GI patients not affected by FI

4

P<.01

Score*
...
Normal Defecation
At rest

Straining to defecate

Symphysis
pubis
Coccyx
Anorectal
angle

Anorectal
angle

Puborectalis
Re...
Anatomy of the Anorectum

Welton ML et al. Anorectum. In: Doherty GM, ed. Current Diagnosis & Treatment Surgery. New York,...
Pathophysiology of Fecal Incontinence

Structural
Abnormalities

Functional
Abnormalities

Rao SSC. Gastroenterology. 2004...
Structural Abnormalities
Anatomic Structure

Cause

Mechanistic Effect

Anal sphincter muscle

•
•

Obstetric injury
Hemor...
Functional Abnormalities
Anorectal sensation impairment1
• May be caused by aging, neurologic damage,
mental impairment2
•...
Stool Characteristics
Stool consistency, volume, and presence of irritants in the stool may
contribute to fecal incontinen...
Most Common Deficiencies Identified in SSc
Patients
• Loss of RAIR
• Decreased Anal Sensation
•Thinning of the IAS

• Fibr...
Diagnostic Evaluation
• History
• Physical exam, including digital rectal exam

• Diagnostic tests

Rao SSC et al. Am J Ga...
Potential Risk Factors and Relevant Coexisting
Medical Conditions
Variable
BMI (per unit)

Odds Ratios (95% CI)
1.1 (1.004...
Assess Diet, Medications, and Lifestyle
Fiber

Fiber supplements, whole-grain cereals or bread, wholewheat based cereals

...
Assess Diet, Medications, and Lifestyle

Drugs that alter
sphincter tone

Nitrates, calcium channel antagonists, beta-bloc...
Diagnostic Testing
Physiologic
Test

Measurements

Anorectal
manometry1

Quantifies sphincter
pressures, sensation, rectal...
Anorectal Manometry

High-Resolution Manometry Catheter:
• 10 distal sensors
• 2 Proximal sensors
Resting Pressure

Normal

Weak
RAIR
Normal

Failed
Internal Anal Sphincter Thinning

Normal IAS

Thinned IAS
Management of Fecal Incontinence
• Diet changes

• Lifestyle modification/Non-pharmacological interventions

• Medical the...
Dietary and Lifestyle Interventions for
Fecal Incontinence
• If stools are frequent and/or loose, evaluate intake of
ferme...
Behavioral Techniques for Fecal Incontinence
• Avoid rushing to the toilet
•Increases abdominal wall contraction which inc...
Non-pharmacologic Management of
Fecal Incontinence
Intervention
Incontinence
pads

Enemas

Anorectal
biofeedback

Mechanis...
Long-term Results of Biofeedback for
Fecal Incontinence
60
Solid Stool FI Assessed
1,6,36,60 MONTHS

48.1

50

Percentage
...
Pharmacologic Management of
Fecal Incontinence
• Antidiarrheals

•Tricyclic antidepressants

• Bile acid binding resins
No...
Injectable Gel Treatment for FI
• Biocompatible gel of dextranomer
microspheres in hyaluronic acid

• FDA-approved for the...
Solesta ® Injection Pivotal Trial:
Primary Endpoint Data
Significantly higher responder rates in injection
group at 6 mont...
16.0

15.0

14.0

52.2%

54.4%

57.4%

60%
50%

44.1%

12.0

40%

10.0

8.6

30%
7.3

8.0

7.0

6.2

6.0

20%
10%

4.0

2....
Solesta® Injection: Adverse Events
Dextranomer
Microspheres
(n=136)

Sham
(n=70)

Proctalgia

19 (14%)

2 (3%)

Rectal hem...
Sacral Nerve Stimulation System
1. Tined lead is placed parallel
to the sacral (S2, S3, or S4)
nerve

3

2. Implantable
ne...
SNS Placement
Sacral Nerve Stimulation System:
Bowel Control Study
Most common adverse events (≥5%) reported during the
implant phase:1
...
Sacral Nerve Stimulation In SSc
• 5 women
• All failed conventional
therapy
• Liquid and solid stool

• Median # weekly FI...
Artificial Anal Sphincter
Cuff placed around upper anal canal1

Tubing from cuff is directed along
perineum and connected ...
Treatment Options for Fecal Incontinence

Conservative
Therapies

Solesta® Injection

• Generally safe

•

Generally safe
...
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Fecal Incontinence in the Scleroderma Patient

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Fecal Incontinence in the Scleroderma Patient: What We Know and Where We Should Go

Darren M. Brenner, MD Assistant Professor of Medicine and Surgery Northwestern University—Feinberg School of Medicine

Presented at Scleroderma Patient Education Conference - Saturday, October 19, 2013

Conference hosted by the Scleroderma Foundation, Greater Chicago Chapter and the Northwestern Scleroderma Program

Published in: Health & Medicine, Education
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Fecal Incontinence in the Scleroderma Patient

  1. 1. Northwestern University Feinberg School of Medicine Fecal Incontinence in the Scleroderma Patient: What We Know and Where We Should Go Darren M. Brenner, MD Assistant Professor of Medicine and Surgery Northwestern University—Feinberg School of Medicine
  2. 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 Jgastroenterol 1999;34;409-13.
  3. 3. Fecal Incontinence Has a Profound Impact on Quality of Life FI patients GI patients not affected by FI 4 P<.01 Score* 3 2 1 Lifestyle Coping Depression Embarrassment QoL significantly lower for SSc patients with FI compared to SSc patients without FI and controls *Quality of life measured using the Fecal Incontinence Quality of Life Scale, a validated 4 scale, 29-item survey. Rockwood TH et al. Dis Colon Rectum. 2000;43:9-16.; Mohamed and Lett J Rheumatolo 2012;39:92-6.
  4. 4. Normal Defecation At rest Straining to defecate Symphysis pubis Coccyx Anorectal angle Anorectal angle Puborectalis Rectum External anal sphincter Modified from AGA slide: IV-9 Descent of pelvic floor
  5. 5. Anatomy of the Anorectum Welton ML et al. Anorectum. In: Doherty GM, ed. Current Diagnosis & Treatment Surgery. New York, NY: The McGraw-Hill Companies, Inc.;2010:698-723.
  6. 6. Pathophysiology of Fecal Incontinence Structural Abnormalities Functional Abnormalities Rao SSC. Gastroenterology. 2004;126:S14-S22. Stool Characteristics
  7. 7. Structural Abnormalities Anatomic Structure Cause Mechanistic Effect Anal sphincter muscle • • Obstetric injury Hemorrhoidectomy, anal dilation, secondary to neuropathy Sphincter weakness Loss of sampling reflex Rectum • • • • • • Inflammation IBD Radiation Rectal prolapse Aging IBS Loss of accommodation Loss of sensation Hypersensitivity Puborectalis muscle • • • Excessive perineal descent Aging Trauma Obtuse anorectal angle Sphincter weakness Pudendal nerve • • • Obstetric or surgical injury Excessive straining/perineal descent Rectal prolapse Sphincter weakness Sensory loss, impaired reflexes CNS, spinal cord, ANS • • • Spinal cord, head injury Back surgery Multiple sclerosis, diabetes, stroke, avulsion injury Loss of sensation Impaired reflexes Secondary myopathy Loss of accommodation ANS=autonomic nervous system; CNS=central nervous system Rao SSC et al. Am J Gastroenterol. 2004;99:1585-1604.
  8. 8. Functional Abnormalities Anorectal sensation impairment1 • May be caused by aging, neurologic damage, mental impairment2 • Impairment in anorectal sensation may lead to:1 - Excessive accumulation of stool - Fecal overflow - Impairment of the sampling reflex Fecal impaction caused by dyssynergic defecation1 • May result in fecal retention with overflow and leakage of liquid stool 1. Rao SSC et al. Am J Gastroenterol. 2004;99:1585-1604; 2. Engel AF et al. Gut. 1994;35:857-859.
  9. 9. Stool Characteristics Stool consistency, volume, and presence of irritants in the stool may contribute to fecal incontinence • Large-volume liquid stools require intact sensation and unimpaired sphincter function to be retained Stool characteristics may be influenced by: • Infection (SIBO)Diarrhea • Inflammatory bowel disease • Irritable bowel syndrome • Medications • Food intolerances Rao SSC et al. Gastroenterology. 2004;126:S14-S22.
  10. 10. Most 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
  11. 11. Diagnostic Evaluation • History • Physical exam, including digital rectal exam • Diagnostic tests Rao SSC et al. Am J Gastroenterol. 2004;99:1585-1604.
  12. 12. Potential Risk Factors and Relevant Coexisting Medical Conditions Variable BMI (per unit) Odds Ratios (95% CI) 1.1 (1.004, 1.1) Current smoker 4.7 (1.4, 15) Diarrhea 53 (6.1, 471) IBS 4.8 (1.6, 14) Cholecystectomy 4.2 (1.2, 15) Rectocele 4.9 (1.3, 19) Stress urinary incontinence 3.1 (1.4, 6.5) Obstetric risk factors (grade 1) 0.8 (0.4, 1.9) Obstetric risk factors (grade 2) 1.1 (0.4, 3.6) Obstetric risk factors (grade 3) 1.9 (0.7, 5.2) Bharucha AE et al. Gastroenterology. 2010;139:1559-1566.
  13. 13. Assess Diet, Medications, and Lifestyle Fiber Fiber supplements, whole-grain cereals or bread, wholewheat based cereals Certain fruits and vegetables Rhubarb, figs, prunes, plums, beans, cabbage, sprouts Spices Chili powder Alcohol Especially stouts, beers, or ales Lactose/fructose Milk, other high-lactose or high-fructose foods Caffeine Coffee, tea, sodas Vitamin and mineral supplements Excessive vitamin C, magnesium, phosphorus, and/or calcium Olestra fat substitute Can cause loose stools Adapted from National Institute for Health and Clinical Excellence (NICE). CG49 Faecal incontinence: tables. Available at: http://www.nice.org.uk/CG49Tables#table2. Accessed March 30, 2013.
  14. 14. Assess Diet, Medications, and Lifestyle Drugs that alter sphincter tone Nitrates, calcium channel antagonists, beta-blockers, sildenafil, SSRIs Broad-spectrum antibiotics Cephalosporins, penicillins, erythromycin Topical drugs applied to anus Glyceryl trinitrate ointment, diltiazem gel, bethancechol cream, botulinum toxin A injection Drugs causing profuse loose stools Laxatives, metformin, orlistat, SSRIs, magnesium-containing antacids, digoxin Tranquilizers or hypnotics Benzodiazepines, SSRIs, antipsychotics Adapted from National Institute for Health and Clinical Excellence (NICE). CG49 Faecal incontinence: tables. Available at: http://www.nice.org.uk/CG49Tables#table2. Accessed March 30, 2013
  15. 15. Diagnostic Testing Physiologic Test Measurements Anorectal manometry1 Quantifies sphincter pressures, sensation, rectal compliance and recto-anal reflexes Assesses IAS and EAS thickness, integrity Endoanal ultrasound Surface EMG1 Provides information on normal or weak tone Adapted from: Rao SSC. Clin Gastroenterol Hepatol. 2010;8:910-919. Evidence Good Good Fair
  16. 16. Anorectal Manometry High-Resolution Manometry Catheter: • 10 distal sensors • 2 Proximal sensors
  17. 17. Resting Pressure Normal Weak
  18. 18. RAIR Normal Failed
  19. 19. Internal Anal Sphincter Thinning Normal IAS Thinned IAS
  20. 20. Management of Fecal Incontinence • Diet changes • Lifestyle modification/Non-pharmacological interventions • Medical therapies • Surgical interventions
  21. 21. Dietary and Lifestyle Interventions for Fecal Incontinence • If stools are frequent and/or loose, evaluate intake of fermentable, poorly absorbed carbohydrates • Consider evaluation for lactose maldigestion or fructose malabsorption •Evaluate relationship between caffeine intake1 and symptoms
  22. 22. Behavioral Techniques for Fecal Incontinence • Avoid rushing to the toilet •Increases abdominal wall contraction which increases chance of fecal incontinence •Reduces focus on pelvic floor • Stop and perform Kegel exercise and proceed to toilet • Clean, squeeze, reclean • After bowel movement, clean anus, perform 2-3 Kegel exercises, then re-clean • If stool present, may have avoided fecal incontinence • Delay bowel movement after biofeedback therapy • Start with brief periods, then increase; improves confidence • Wean off laxatives and anti-diarrheals .
  23. 23. Non-pharmacologic Management of Fecal Incontinence Intervention Incontinence pads Enemas Anorectal biofeedback Mechanism of Action Side Effects Provides skin protection; prevents soiling; conduct moisture away from skin Skin irritation Evacuates rectum, decreasing likelihood of FI Comments Inconvenient; side effects from specific preparations Improves rectal sensation; coordinates external anal sphincter contraction; may increase anal sphincter tone None Whitehead WE, Bharucha AE. Gastroenterology. 2010;138:1231-1235. Disposable provides better skin protection than nondisposable 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
  24. 24. Long-term Results of Biofeedback for Fecal Incontinence 60 Solid Stool FI Assessed 1,6,36,60 MONTHS 48.1 50 Percentage 40 52.5 38 Biofeedback No treatment 30 22.5 20 12.5 12.5 11.4 10 2.5 0 Group A Group B Group C Group D Group A: Continence fully recovered Group B: >75% reduction in # of incontinence episodes Group C: <75% reduction in # of incontinence episodes Group D: No improvement or worse than before therapy Lacima G et al. Colorectal Dis. 2010;12(8):742-749.
  25. 25. 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 SSc patients with fecal incontinence
  26. 26. 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
  27. 27. Solesta ® Injection Pivotal Trial: Primary Endpoint Data Significantly higher responder rates in injection group at 6 months (Responder)* 80 P=.0089 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) 60 40 52% n=136 31% n=70 20 0 Injection *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. Sham
  28. 28. 16.0 15.0 14.0 52.2% 54.4% 57.4% 60% 50% 44.1% 12.0 40% 10.0 8.6 30% 7.3 8.0 7.0 6.2 6.0 20% 10% 4.0 2.0 0% 0.0 -10% Baseline 3 months 6 months 9 months 12 months Episodes reduction Graf W et al on behalf of the NASHA Dx Study Group. Lancet. 2011; 377: 997–1003. Proportion responders Median number of episodes/14 days Secondary Endpoint: Decrease in FI Episodes After Solesta® Treatment
  29. 29. Solesta® Injection: Adverse Events Dextranomer Microspheres (n=136) Sham (n=70) Proctalgia 19 (14%) 2 (3%) Rectal hemorrhage 10 (7%) 1 (1%) Diarrhea 7 (5%) 3 (4%) Injection site bleeding 7 (5%) 12 (17%) Rectal discharge 5 (4%) — Anal pruritis 2 (2%) — Proctitis 4 (3%) — Painful defecation 2 (2%) — Fever 11 (8%) — Rectal abscess* 1 (1%) — Prostate abscess* 1 (1%) — 22 (16%) 5 (7%) Others *Serious adverse event Graf W et al on behalf of the NASHA Dx Study Group. Lancet. 2011; 377: 997–1003.
  30. 30. Sacral Nerve Stimulation System 1. Tined lead is placed parallel to the sacral (S2, S3, or S4) nerve 3 2. Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes 2 1 3. Clinician and patient programmers are used to set the parameters of the electrical pulses InterStim II Neuromodulator [manual]. Medtronic, Inc. Minneapolis, MN. 2012.
  31. 31. SNS Placement
  32. 32. Sacral Nerve Stimulation System: Bowel Control Study Most common adverse events (≥5%) reported during the implant phase:1 Adverse Event Frequency (%) Implant site pain 25.8% Paresthesia 12.5% Implant site infection 10.8%2 Change in sensation of stimulation 8.3% Urinary incontinence 6.7% Diarrhea 5.0% 26 SAEs: 13 (10.8%) experienced implant site infection. 5 infections treated with medication; 7 (5.8%) required surgical intervention (5 device explants and 2 device replacements) Wexner SD, Coller JA et al. Ann Surg. 2010;251:441-449.
  33. 33. Sacral Nerve Stimulation In SSc • 5 women • All failed conventional therapy • Liquid and solid stool • Median # weekly FI episodes=15 Weekly Incontinent Episodes 25 20 15 10 5 0 Pre-SNS Post-SNS • Duration SSc=13 yrs • Duration FI=5 years Kenefick et al. Gut 2002;51:81-83 Patient 5: lead displdged in 1st 24 hours Max response time 60 months Improvements in urgency, QoL Elevations in resting pressures identified
  34. 34. Artificial Anal Sphincter Cuff placed around upper anal canal1 Tubing from cuff is directed along perineum and connected to pump implanted just below skin of scrotum or labia Limited clinical experience1 • In a post-hoc analysis (n=37), normal continence for liquid stool was 78.9%; normal continence for gas was 63.1%1 • ~12% failure rate1 • No data in Scleroderma patients 1. Michot F et al. Ann Surg. 2003;1:52-56.
  35. 35. Treatment Options for Fecal Incontinence Conservative Therapies Solesta® Injection • Generally safe • Generally safe • Limited evidence of benefit • Requires in-office procedure • Not commonly successful in SSc • Longer-term evidence for benefit required Surgical Therapies • Invasive • Potential safety issues • Long-term benefit may be limited but initial data for SNS good
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