Fecal Incontinence: A Primer for Individuals with Scleroderma
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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.
![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/sclerodermafilecture2014final-141020172152-conversion-gate02/85/Fecal-Incontinence-A-Primer-for-Individuals-with-Scleroderma-14-320.jpg)
![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.](https://image.slidesharecdn.com/sclerodermafilecture2014final-141020172152-conversion-gate02/85/Fecal-Incontinence-A-Primer-for-Individuals-with-Scleroderma-16-320.jpg)
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.
- 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
Editor's Notes
- #2: 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.
- #3: 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 month The 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
- #4: 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
- #5: 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
- #7: 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
- #13: This slide provides a brief overview of nonpharmacologic modalities for managing fecal incontinence
- #14: 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.
- #16: 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)
- #17: 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