1
Satish SC Rao, MD, PhD, FRCP (Lon), FACG, AGAFProfessor of Medicine
Director, Neurogastroenterology/MotilityDirector, Digestive Health Clinical Research Center
Medical College of Georgia Augusta University, Augusta, GA
Common Anorectal Disorders
Disclosures
Advisory Board: Ironwood Pharmaceuticals InTone MV Synergy Pharmaceuticals Valeant Pharmaceuticals
Research Support National Institutes of Health Forest Labs/Ironwood Synergy Pharmaceuticals InTone MV
OBJECTIVES
Discuss advances in Evaluation, Diagnostic Tests & Treatment:
Dyssynergic Defecation
Fecal Incontinence
Case Study 41-yr-old school teacher
Increasing constipation- 3 yearsBegan during college daysNow, B.M once every 1-2 weeks, hard, pellet-
like stool only after Fleet’s enema + Suppository and laxatives
Uses digital maneuvers, and describes excessive straining, incomplete evacuation and occasional bleeding
Tried OTC laxatives, lubiprostone, PEG-no relief
History Contd..
Past Hx: Migraines, seasonal allergy, No back or pelvic injury, Gravida 1, para 1, No Forceps.
Drugs: Minocycline 100mg bid, Nasal spray, HFD=30g/day, Senna=2/day, PEG=34g/day,
O/E: lower abdominal fullness
What next?
3-step DRE-PROTOCOL
1) Inspection
2) Perianal sensation & anocutaneous reflex: normal, impaired, absent
3) Digital maneuvers: mass, tenderness, stool
Squeeze x 2: normal, weak, increased
Bearing down x 2 push effort, sphincter relaxation, perineal descent
Clinically dyssynergia if … any 2; • inability to
•contract abdominal muscles •relax anal sphincter
• paradoxical contraction of anal sphincter • absence of perineal descent
Tantiphlachiva K, Rao S et al, CGH 2010
2
Yield of rectal exam in dyssynergia, n=209
� All patients had � DRE
� Anorectal manometry
� Balloon Expulsion Test
� Data Analyzed independently
ParameterSensitivity
(%)Specificity
(%)
Dyssynergia from DRE 75% 87%
Balloon expulsion test 49% 90%
Tantiphlachiva K, Rao S et al, CGH 2010
Functional Subtypes:Primary Constipation
Schiller LR. Aliment Pharmacol Ther. 2001;15:749.Mertz H, et al. Am J Gastroenterol. 1999;94:609.
Slow transit and IBS-C overlap in half of each group
Evacuation Disorders59%
IrritableBowel Syndrome58%
Slow-Transit Constipation47%
•Dyssynergic Defecation
Outlet Obstr.•Rectocele•Descending perineum syndrome•Rectal prolapse
Tests of Anorectal Function
Anorectal high resolution manometry
Anal Endosonography
Rectal Compliance Test
Pudendal Nerve Terminal Latency
Balloon expulsion test
Defecography
Anal High Definition Manometry
Electromyography
Translumbar/transsacral MEP
Modified from Rao, ACG Guidelines, Am J Gastro 2004
HRM Probes
Types of Dyssynergic Defecation
Normal
Rectal
Anal
Rao et al, Neurogastroenterol Motil 2004; 16: 589
3
Grossi U, et al. Gut 2015
Defecation Index vs RA Gradient
Defecation index Recto-anal pressure gradient
45/30 = 1.50 = ND -8.5 = DD
45 mmHg
30 mmHg
43
51.5
Effect of Body Position on Defecation Patterns
Rest Bearing down
Rectal pressure
Anal pressure
Rest Bearing down
Rectal pressure
Anal pressure
Bearing Down Lying Bearing Down on Commode
Courtesy of S.Rao
Assessment of Dyssynergic Defecation
• Dyssynergia should be assessed in sitting position
• Ideally with a distended balloon in rectum• RA gradient as assessed by software is
inaccurate for dyssynergia- overestimates !• Defecation index is a better measure for
evaluating dyssynergia
Diagnostic Criteria-Dyssynergic Defecation
1. The patient must satisfy diagnostic criteria for functional constipation-Rome III
2. During repeated attempts to defecate must demonstrate Dyssynergic pattern of defecationManometry EMG
3. Patient must demonstrate one other abnormal test:a. Abnormal balloon expulsion Test (> 1 minute)b. Prolonged Colonic Transit Time (radioopaque
markers or SmartPill or Scintigraphy)c. Abnormal Defecogarphy (>50% barium
retention) Bharucha et al, Gastroenterology 2006; 130: 1514Rao SSC. Gastroenterol Clin N Am 36 (2007) 687-711
How to Treat Dyssynergic Defecation ?
General Measures Diet, exercise, fluids & habit training Laxatives/Prokinetics
Specific Treatment Botox injection Biofeedback therapy Cognitive Behavioral Therapy Surgery
Myectomy- 30% improvement Colostomy
Rao SSC. Gastroenterol Clin N Am (2008)
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Biofeedback Therapy
A technique of conditioning and/or retraining the mind and body to normalize bowel movement.
�
How many of you perform Biofeedback ?
Biofeedback-Dyssynergia
» Goals of Therapy :• A) Teach Diaphragmatic
breathing exercise
• B) Teach anal sphincter &
pelvic floor relaxation
• C) Improve Rectal Sensation
• D) Eliminate Sensory Delay
• E) Improve Recto-anal Coordination
Post-Biofeedback-Attempted Defecation
RECTUM
ANUS
Biofeedback Therapy-RCTs
Biofeedback Vs PEG 14.6 g for Dyssynergia Chiarioni et al, Gastroenterology 2006; 130: 657-64
Biofeedback vs Diazepam for Dyssynergia Heymen et al, Dis Col Rectum 2007
Biofeedback vs Sham Therapy vs Standard Therapy Rao et al CGH 2007
Biofeedback vs Standard Therapy-One Year outcome Rao et al Am J Gastroenterol 2010
Home vs Office Biofeedback Therapy-Efficacy & Cost Effectiveness Rao et al, Go et al, DDW 2011
RCT-Biofeedback Therapy for Dyssynergian=77
Standard Treatment Biofeedback Therapy Sham Feedback
Symptom questionnaire, Stool diary, Colonic Transit, ARM, Balloon Expulsion test
Rao et al CGH 2007
Effects of Biofeedback Therapy on CSBM & Dyssynergia- ITT Analysis
Rao et al Clin Gastro Hepatol 2007
5
0
1
2
3
4
5
6
7
Biofeedback Standard
Mea
n C
SB
Ms
/ W
eek
±S
.E.
BaselineOne Year¤ §
§ p<0.0001 vs Standard
¤ p<0.0001 vs Baseline
Rao et al Am J Gastro 2010
Long Term Outcome of Biofeedback- CSBM/week
Home vs Office Biofeedback-Responder Analysis
TOST= p =0.006
Rao et al DDW 2011
CONCLUSIONS
Biofeedback Therapy
Effectively improves symptoms and anorectal function
This effect is mediated by modifying their physiologic behavior
Biofeedback therapy provides sustained improvement in bowel function
Home Biofeedback is as effective as Office Biofeedback and more cost effective
Should be the preferred treatment for patients with dyssynergia, especially when patients fail Standard Therapy
Rao et al Clin Gastro Hepatol 2011
EBM – Biofeedback Therapy
Condition Level Recommend
Dyssynergic Defecation I A
Fecal Incontinence II B
Levator Ani Syndrome II B
Solitary Rectal Ulcer Syndrome III C
Children with Functional Constipation (Encopresis)
I D
Rao SS et al, ANMS & ESNM Position paper. Neurogastro Mot 2015:
CASE STUDY
AH: 47 yrs, Gravida 3, Para 2
2005 - Fecal Incontinence - 2 months after delivery.
2012 - 2nd Delivery, symptoms have worsened. B.M. - 2/day; 4-8 incontinence episodes/wk-10yrs Senses stool coming out but cannot stop it. Flatus incontinence No urinary incontinence, back injury or diabetes. Hypothyroid Tried Psyllium, loperamide 4mg/tid-No relief
Prevalence of Fecal Incontinence: Fast Facts
Overall prevalence of fecal incontinence: 9.0%
Prevalence of fecal incontinence occurring at least once weekly:
1.1%
Prevalence in men: 7.4%
Prevalence in women: 9.1%
Prevalence in individuals aged ≥70 years: 17.5%
Prevalence of FI (≥1 time in previous month)*
Su
bje
cts
(%)
*Data from NHANES 2005/2006 and 2009/2010 surveys. N=52,195.Ditah I et al. Am J Gastroenterol. 2012;107:S717. Abstract 1762.
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Vaginal DeliverySphinc. Tear
n=365
Vaginal DeliveryNo Tearn=356
C-Sectionn=116
Odds Ratio ST vs. NT
Odds RatioNT vs. CS
FI at 6 weeks 27% 11% 10%2.8
p<0.0011.1
p=0.82
Solid & Liquid 7% 1.4% 0.9%
Liquid Only 13.7% 6.5% 4.3%
Solid Only 3.6% 2.5% 3.5%
Flatus Only 24.7% 20.2% 18.1%1.6
p=0.031.3
p=0.45
FI at 6 months 17% 8% 7.6%1.9
p<0.011.01
p=0.98
Solid & Liquid 4% 2% 1%
Liquid Only 8% 4% 4%
Solid Only 4.2% 0.3% 1%
Flatus Only 23% 18% 27%
Nygaard, et al. JAMA. 2007.
Does Vaginal Delivery Predispose to Fecal Incontinence?
Fecal Incontinence – History & Examination
Establish rapport & Overcome social stigma
Onset & Precipitating events
Duration, Severity & Timing
Coexisting problems/Surgery/Urinary Incontinence
Obstetric Hx-Forceps, Tears, Presentation, Repair
Drugs, Caffeine, Diet
Clinical Subtypes & Grading
Physical, Neurological & DRE
Rao SS. Am J Gastroenterol. 2004;99:1585-604.
Fecal Incontinence-Clinical Subtypes
Passive Incontinence Involuntary discharge of feces or flatus
without awareness
Urge IncontinenceDischarge of rectal contents in spite of
active attempts to retain
Fecal Seepage Involuntary seepage with otherwise
normal evacuation
Rao, ACG Guidelines, Am J Gastro 2004
Anal Sphincter Changes in Health & FI
Normal
HDMAUS
Incontinent
Squeeze
rest
Squeeze
rest
Squeeze
defectdefect
Nguyen M, Rao S et al, DDW 2011
Trans-lumbar & Trans-sacral MEPs
Fig. 2 Schematic of Magnetic stimulation
Tantiphlachiva K, Rao SS et al DDW 2008
Case Vignette: Incontinent vs Healthy
Healthy
Patient
LEFT RIGHT
Sacro-anal MEPs
Tantiphlachiva K, Rao SS, et al. Am J Gastroenterol. 2011.
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Trans-lumbar MEPs: Incontinence vs Controls
Tantiphlachiva K, Rao SS et al Dis Colon Rectum 2014
Rectal MEPs Anal MEPs
Pharmacological Treatment of Incontinence
Fiber Supplementation LoperamideDiphenoxylate/atropine (Lomotil®) LactuloseCholestyramine/colestipolAmitriptylineValproic acidClonidine Topical Therapy
EstrogensPhenylephrine Zinc-Aluminum
Clinical Utility of ARM in Fecal Incontinence
-Rao et al, Am J Gastro1997; 92:469-75
Cochrane Review of Medical Therapy-2013
16 trials (11 cross over), n=558
11 Trials of F.Incontinence + Diarrhea
7 tested antidiarrheals, 6 enhance anal sphincter function (Phenylephrine, valproic acid), 2 tested Lactulose, 1 zinc aluminum
Small studies, short F.up, meta-analysis not possible
Risk of bias unclear
Conclusions:
Focus of most therapy was diarrhea not incontinence
Little evidence to guide clinicians, Larger well designed trials are required
Omar et al , Cochrane data base systematic rev 2013
Goals of Neuromuscular Training for Fecal Incontinence
Rao, ACG Guidelines. Am J Gastro. 2004.
Biofeedback Therapy
Strengthen anal sphincter/Puborectalis muscleEndurance + Strength
Improve rectal sensation/sensory delay
Rectoanal coordination training Isolation of anal muscles
Control of Accessory Muscles
Training to correct dyssynergia & evacuation
Biofeedback vs Non-digital assisted squeezes-Incontinence: Primary Outcome
* P < 0.001
**
Heymen S, Whitehead W et al, DDW 2007
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Responder Analysis, Home vs Office Biofeedback
P=1.000
Xiang X, Sharma A, Rao SS. ACG 2017
Surgical Treatment of Incontinence
Sphincteroplasty
Rectal Augmentation
SECCA procedure
Sacral nerve stimulation
Maloney-ACE procedure
Colostomy
Rao, ACG Guidelines, Am J Gastro 2004
Long Term Data
Glasgow, Lowry DCR 2012
SPHINCTEROPLASTY long term results
Sacral Nerve Stimulation for Incontinence
4-6 needles,bilaterally, S2-S4, Temporary –14 days, later Permanent
Rao SS, Am J Gastroenterol 2004; 99:1585-604
Sacral Nerve Stimulation System: Bowel Control Study
Wexner SD, Coller JA et al. Ann Surg. 2010;251:441-449.
Per
cen
t o
f P
atie
nts
3 Months(n=113)
6 Months(n=107)
12 Months(n=106)
24 Months(n=67)
36 Months(n=30)
Follow-up Interval
Improvement in Weekly Incontinent Episodes
Significantly higher responder rates in Solesta group at 6 months (Responder50)
53.2%
30.7%
0
20
40
60
80
Solesta Sham
Proportion responders 5
0(%
)
D p ‐value = 0.004D p ‐value = 0.004
All 3 pre‐specified success criteria at 6 and 12 months were
met
Graf et al, Lancet 2011; 377: 997–1003
Efficacy of Dextranomer (Solesta®) in F.Incontinence, RCT
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Mellgren A et al, NGM 2014
Long Term Efficacy of NASHA
New devices for Fecal Incontinence
Role of anal/vaginal plugs & Devices: Fenix®, Renew®, Vaginal insert (Pelvalon®)
EBM – Incontinence – 2017
Treatment Modality Level RecommendationPharmacological
Loperamide II BDiphenoxylate/atropine II BLactulose II C
Fiber supplements II BClonidine II C
Topical TherapyZinc Aluminum II BEstrogen II BPhenylephrine I C
Biofeedback Therapy I ASNS II BTENS/PTNS I CDextranomer (NASHA Dx) I A
Take Home Points
Detailed History, Physical & DRE important Dyssynergic defecation is common but HRM and
HDM are sensitive and should be used appropriately for accurate diagnosis
Fecal incontinence is multifactorial ARM, Anal Ultrasound, MRI, Neurophysiology
Tests are complementary Life style measures, antidiarrheals are helpful
Therapeutic options will depend on a clear understanding of pathophysiology
Biofeedback should be preferred option Selected cases surgery or SNS or Dextranomer