Fecal Incontinence in the Scleroderma Patient
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The document discusses the prevalence and impact of fecal incontinence in scleroderma patients, noting that it affects 22-38% of this population compared to 9% in the general population. It highlights the pathophysiology, risk factors, and various management strategies, including dietary modifications, pharmacological treatments, and surgical options like sacral nerve stimulation. Inadequate studies evaluating pharmacologic treatments in this specific group suggest a need for further research into effective management approaches.
![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](https://image.slidesharecdn.com/brennersclerodermafilecture2013final-131030082052-phpapp01/85/Fecal-Incontinence-in-the-Scleroderma-Patient-26-320.jpg)
![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.](https://image.slidesharecdn.com/brennersclerodermafilecture2013final-131030082052-phpapp01/85/Fecal-Incontinence-in-the-Scleroderma-Patient-30-320.jpg)
Fecal Incontinence in the Scleroderma Patient
- 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. 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. 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. 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. 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. Pathophysiology of Fecal Incontinence Structural Abnormalities Functional Abnormalities Rao SSC. Gastroenterology. 2004;126:S14-S22. Stool Characteristics
- 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. 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. 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. 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. Diagnostic Evaluation • History • Physical exam, including digital rectal exam • Diagnostic tests Rao SSC et al. Am J Gastroenterol. 2004;99:1585-1604.
- 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. 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. 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. 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. Anorectal Manometry High-Resolution Manometry Catheter: • 10 distal sensors • 2 Proximal sensors
- 19. Internal Anal Sphincter Thinning Normal IAS Thinned IAS
- 20. Management of Fecal Incontinence • Diet changes • Lifestyle modification/Non-pharmacological interventions • Medical therapies • Surgical interventions
- 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. SNS Placement
- 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. 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. 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. 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