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Keynote Lecture: Fecal Incontinence

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<strong>Fecal</strong> <strong>Incontinence</strong><br />

The Cleveland Clinic Foundation<br />

Cleveland, Ohio<br />

Tracy L. Hull, M.D.<br />

Professor of Surgery<br />

Digestive Disease Institute<br />

Department of Colorectal Surgery


Several organs in the body were arguing about who was<br />

the most important<br />

• The HEART said it was the most important because it<br />

pumped the blood.<br />

• The BRAIN ‘thought’ it was the most important<br />

because it integrated all information and made<br />

decisions.<br />

• The EYES ‘viewed’ themselves as the most important<br />

because they could tell the body where it was going.<br />

• The KNEES thought they were the most important<br />

because they carried the body where it wanted to go


• Nobody would listen to the ANAL SPHINCTERS<br />

• Therefore they shut down<br />

• After a couple of days of the anus and bowel not<br />

working properly, the eyes went glassy, the<br />

knees buckled, the brain turned to jelly, and the<br />

heart skipped a beat<br />

• Finally they all said “All right ANAL<br />

SPHINCTER, you are the BEST.”


• A normally<br />

functioning anal<br />

sphincter is a gift<br />

from GOD<br />

--anonymous


• Life miserating<br />

• Evaluating<br />

improvement after<br />

treatment is difficult<br />

as no standard<br />

definition for severity<br />

and frequency exists<br />

• Successful outcome is<br />

impossible to define<br />

<strong>Fecal</strong> <strong>Incontinence</strong>


Prevalence based on 16<br />

studies of community<br />

dwelling adults<br />

• Anal incontinence<br />

including flatus 2-24%<br />

• Anal incontinence<br />

(excluding flatal)<br />

0.4-18%<br />

Macmillan et al DCR 2004<br />

<strong>Fecal</strong> <strong>Incontinence</strong>


• Obstetrical injury is<br />

the most common<br />

cause of fecal<br />

incontinence<br />

<strong>Fecal</strong> <strong>Incontinence</strong>


Other Causes<br />

• Surgical trauma (fistulotomy,<br />

hemorrhoidectomy, sphincterotomy)<br />

• Irradiation<br />

• Colitis<br />

• Rectal prolapse<br />

• Central nervous system problems<br />

• Diabetes<br />

• Scleroderma<br />

• Medications<br />

• Others<br />

<strong>Fecal</strong> <strong>Incontinence</strong>


Comprehensive History<br />

• Duration, frequency<br />

• Quality of stool lost<br />

• Flatus control<br />

• Pad use<br />

• Urgency<br />

• Affect on daily life<br />

• Urinary incontinence<br />

<strong>Fecal</strong> <strong>Incontinence</strong><br />

• Obstetric history<br />

• Surgical history<br />

• Other medical problems<br />

• Medications<br />

• Psychosocial<br />

ramifications of<br />

incontinence


Physical exam<br />

• Careful exam of<br />

perineum, anus, and<br />

rectum<br />

Anal ultrasound<br />

• Preferred tool to map<br />

sphincters<br />

• Not always needed but<br />

may be helpful<br />

<strong>Fecal</strong> <strong>Incontinence</strong>


Treatment of <strong>Fecal</strong> <strong>Incontinence</strong><br />

• Treatment options<br />

depend on clear<br />

understanding of<br />

pathophysiology<br />

• Standard treatment starts<br />

with addressing<br />

underlying conditions


Non-Surgical Treatment:<br />

forgotten aspects<br />

• Skin care<br />

• Barrier creams for<br />

protection<br />

• Cotton ball by anus<br />

• Use of baby wipes<br />

<strong>Fecal</strong> <strong>Incontinence</strong>


<strong>Fecal</strong> <strong>Incontinence</strong>: Medical Treatment<br />

• Evaluate and treat diarrhea<br />

• Biofeedback<br />

• Anal plug<br />

• SECCA


<strong>Fecal</strong> <strong>Incontinence</strong>: Medical Treatment<br />

• Evaluate and treat diarrhea<br />

• Biofeedback (pelvic floor<br />

retraining)<br />

• Anal plug<br />

• SECCA


Pelvic Floor Retraining: Biofeedback<br />

• Uses EMG or manometry for visual input<br />

(auditory or visual cue)<br />

• Inexpensive (although many insurance<br />

companies view it as experimental)<br />

• Painless, easy to perform, does not exclude<br />

other tx<br />

• Requires a motivated patient capable of<br />

understanding the treatment AND<br />

MOTIVATED THERAPIST


Biofeedback: Protocols<br />

1. Coordination training—<br />

contract muscle in response to<br />

rectal distension<br />

2. Sensory training—recognize<br />

smaller volumes of rectal<br />

contents<br />

3. Strength training—isolate and<br />

exercise anal muscle (without<br />

rectal distention)


Biofeedback: Outcomes<br />

• N=171 randomized four groups: I) teaching, advice<br />

and support (a), II) + addition of sphincter exercises<br />

(a+b), III) +addition of manometric feedback<br />

(a+b+c), IV) + addition of home training device<br />

(a+b+c+d)<br />

• Continence scores, disease-specific and generic QOL<br />

scores, resting, squeeze, and sustained squeeze<br />

pressures improved in all groups and improvement<br />

was maintained at one year<br />

• Presence and degree of sphincter defect did not<br />

correlate with outcome<br />

Norton Gastroenterology 2003


Biofeedback: Outcomes<br />

• Results vary considerably with reported<br />

success 38-92%<br />

• Success does not diminish in most over time<br />

in few small long term studies (Ryn, Morren 2000)<br />

• May improve function if symptoms persist<br />

w/ successful sphincter repair (Jensen, Lowery 1997)<br />

• No clear patient selection criteria or optimal<br />

protocol


<strong>Fecal</strong> <strong>Incontinence</strong>: Medical Treatment<br />

• Evaluate and treat diarrhea<br />

• Biofeedback<br />

• Anal plug<br />

• SECCA


<strong>Fecal</strong> <strong>Incontinence</strong>: Medical Treatment<br />

• Evaluate and treat diarrhea<br />

• Biofeedback<br />

• Anal plug<br />

• SECCA<br />

Radio-frequency delivered<br />

to target temperature of 85<br />

C for 1 min 23-32 times in<br />

anal canal


SECCA hand piece<br />

• Anoscopic barrel<br />

SECCA: Equipment<br />

• Light pipe for visualization


SECCA: Procedure<br />

• Goal is four rows 5 mm<br />

apart beginning at the<br />

dentate and moving<br />

proximal (may opt to<br />

treat 5 th row)<br />

• 4 needle treatment per<br />

quadrant<br />

• 85 C for 1 min<br />

• Total 64 lesions


SECCA: How Does it Work?<br />

• Mechanism of action is unknown<br />

• “Radiofrequency anal sphincter remodeling”<br />

(fibroblasts to myoblasts)<br />

• No consistent changes in anal physiology or<br />

anal endosonography


SECCA: First Studies<br />

• Feasibility, safety,<br />

efficacy<br />

• N=10 F/U 12 mos<br />

• Wexner 13.5 to 5<br />

(p


First<br />

author<br />

n F/U<br />

mos<br />

SECCA: Results<br />

Preop<br />

Wexner<br />

Efron<br />

2003 50 6 14<br />

Lefebure<br />

2008<br />

15 12 14<br />

Ruiz<br />

2010 24 12 15<br />

Postop<br />

Wexner<br />

11 Multicenter (5)<br />

prospective all FIQOL sig<br />

improved<br />

12 FIQOL only improved<br />

for depression<br />

12 FIQOL improved in all<br />

subsets except depression


SECCA: not all showed improvement<br />

• N=8 F/U 6 mos<br />

• FISI and FIQOL showed no improvement<br />

(except embarrassment scale)<br />

• 7/8 had anal bleeding, mucous discharge, or<br />

anal pain<br />

Kim Am J Surg 2009


SECCA: Complications<br />

• Bleeding and/or anal pain 10-45%<br />

• Ulceration in 2/50 after Efron study (2003)<br />

led to modification of device<br />

• Potential for rectovaginal fistula<br />

• Local hematoma<br />

• The device inserted is large (?? Sphincter<br />

injury)<br />

• Don’t use SECCA after injectables<br />

• No long term complications reported


SECCA: Final Thoughts<br />

• Consider for Wexner score<br />

9-17 and


Injectables: Types<br />

11 injectable bulking agents in the literature<br />

--- Carbon beads (Durasphere)<br />

--- Teflon<br />

--- Silicone (PTQ R )<br />

--- Collagen<br />

--- Calcium hydroxylapatite (Coaptite R )<br />

--- Fat<br />

---Permacol TM<br />

--- Non-animal Hyaluronic<br />

Acid with Dextranomer (NASHA TM DX<br />

[Solesta R ]))


Injectable Agents<br />

• Injectable stabilized<br />

hyaluronic acid<br />

– n=206 randomized double<br />

blinded sham controlled trial<br />

– 52% >50 % reduction in FI<br />

vs 31% control (p=0.0089)<br />

– One rectal abscess and one<br />

prostatic abscess<br />

Graf et al Lancet 2011


Injectables: Results NASH<br />

• N=34 1 cc x 4 submucosal<br />

• F/U 12 mos for all patients<br />

• FI episodes via 4 wk diary<br />

• Median 10 (r 0-70)<br />

versus pre 22 (r 2-77) (p=0.004)<br />

Danielson Dis Colon Rectum 2009


Injectables: Where and How Much<br />

• 7 different techniques in literature<br />

– Submucosal or intersphincteric space<br />

– Route of needle insertion<br />

• Is ultrasound guidance required<br />

• One cc in four quadrants<br />

• Size of needle to implant (21 gauge)


Injectables: Final Thoughts<br />

• We have minimal evidence-based information<br />

to guide us regarding injectables<br />

• Where to inject; what route; how much???<br />

• Are laxatives important?<br />

• Would we improve results if done in OR?<br />

• RCT with sufficient number of patients<br />

and longer F/U needed


<strong>Fecal</strong> <strong>Incontinence</strong>: Surgical Treatment<br />

• Overlapping sphincter repair<br />

• Sacral Nerve Stimulation<br />

• Artificial bowel sphincter<br />

• ACE<br />

• Stoma<br />

• Not used<br />

Park’s post anal repair<br />

Dynamic graciloplasty


Overlapping Sphincter Repair<br />

• Most common procedure<br />

for repair of anterior defect<br />

ADVANTAGES<br />

• Relatively easy<br />

• Low cost<br />

• No fancy equipment needed<br />

• Can be done globally in any<br />

OR


Long-term Results of Overlapping Sphincter Repair<br />

100%<br />

90%<br />

80%<br />

70%<br />

60%<br />

50%<br />

40%<br />

30%<br />

20%<br />

10%<br />

0%<br />

St Marks<br />

2000 n=38<br />

F/U 77 m<br />

France 2000<br />

n=74<br />

F/U 40 m<br />

continent<br />

gas incon<br />

total incon<br />

CCF 2002<br />

n=49<br />

F/U 69 m<br />

U of Minn<br />

2004 n=104<br />

F/U 120 m<br />

CCF 2007<br />

n=41<br />

F/U 126 m


Long Term Outcome Following<br />

Overlapping Sphincter Repair<br />

Why poor long term results?<br />

• ELUS not done to assess<br />

adequate initial repair<br />

• Normal aging of these women’s<br />

muscles?<br />

• Some think fibrosis is more<br />

pronounced in these women and<br />

affects the results<br />

• Unrecognized problem in pelvic<br />

floor


Overlapping Repair: FINAL THOUGHTS<br />

• Long term results of overlapping sphincter<br />

repair may not be as good as previously<br />

assumed<br />

• Overlapping repair of anterior defect is<br />

STILL reasonable treatment


Sacral Nerve Modulation<br />

• 1994 first used for FI<br />

• FDA approved in US<br />

• Adapted from use in<br />

urological disorders<br />

• Unclear mechanism of<br />

action


• 9 Fe 1 M<br />

• PET scan (cerebral blood flow)<br />

– 30 min after continuous stim<br />

started<br />

Sacral Nerve Stimulation<br />

– repeated 2 weeks after<br />

continuous stim<br />

• Initial stim activated contralateral<br />

frontal cortex normally active in<br />

focused attention<br />

Lundby et al Dis Colon Rect 2011


Sacral Nerve Stimulation<br />

• After 2 wks, activation<br />

changed to activity in parts of<br />

ipsilateral caudate nucleus<br />

(thought to be involved in<br />

learning and reward)<br />

• SNS induces changes in<br />

cerebral activity consistent<br />

with effect on afferent<br />

projections of vagus<br />

Lundby et al Dis Colon Rect 2011


Sacral Nerve Stimulation<br />

Indications: FI due to<br />

• Obstetric injury<br />

• Sphincter defect<br />

• Anal trauma<br />

• Cauda equina syndrome<br />

• Rectal resection<br />

• Crohn’s disease with sphincter disruption


Phase 1: Test Stimulation


Phase 2: Implantation of<br />

permanent stimulating device<br />

to the implanted lead


Sacral Nerve Stimulation<br />

Meta-analysis of 34 studies:<br />

• 944 pts with PNE and 665 permanent SNS<br />

• Weekly episodes FI and incontinence scores<br />

significantly reduced<br />

• Ability to defer defecation increased<br />


Sacral Nerve Stimulation<br />

Meta-analysis of 34 studies:<br />

• Results similar +/- sphincter defect<br />

• PNE only predictive test for SNS outcome<br />

• Complication rate was 15% for permanent SNS w/<br />

3% having permanent explantation<br />

• Most common complications (n=665): Pain (6%),<br />

lead problem (4%), infection (3%), seroma (3%)<br />

Tan et al Int J Colorectal Dis 2011


Sacral Nerve Stimulation<br />

14 studies + 9 with sphincter lesions all pos<br />

PNE and had permanent implant:<br />

• 77% improvement idiopathic FI<br />

• 76% improvement in sphincter defect (17-180 0 )<br />

• 78% improvement after OSR<br />

• 73% improvement w/ neurologic injury<br />

Matzel Colorectal Dis 2011


Sacral Nerve Stimulation<br />

14 studies + 9 with sphincter lesions all pos<br />

PNE and had permanent implant:<br />

• Sustained benefit at 14 yrs (longest FU)<br />

• Reduction in clinical efficacy with longterm<br />

FU in 26%<br />

Matzel Colorectal Dis 2011


Sacral Nerve Stimulation<br />

Results EAS defect:<br />

• EAS defect (21); intact (32)<br />

• Both had sig improvement QOL<br />

• Weekly FI 13 to 5 (EAS defect<br />

p


Sacral Nerve Stimulation Results<br />

• Pooling data of 8 studies for 238<br />

• Mean F/U16 mos<br />

• 88% of these patients reported >50% improvement<br />

• Complications 5-26% &


Sacral Nerve Modulation Advantages<br />

Advantages of SNS<br />

• Done under local +<br />

sedation<br />

• Not dependant on<br />

sphincter morphology<br />

• Works for SUI ,<br />

? Constipation, ? IBS<br />

• Good results<br />

Disadvantages of SNS<br />

• 30% will not benefit<br />

• % will not be eligible<br />

• 5-26% device related<br />

complications<br />

• Expensive<br />

• Cannot be done<br />

without C arm facility


Acticon Neosphincter<br />

• Modification of urinary<br />

sphincter 3 parts:<br />

1) inflatable cuff<br />

around anus<br />

2) central pump (labia<br />

in Fe; scrotum in M)<br />

3) regulating balloon<br />

in Space of Retzius


Consider for:<br />

Artificial Bowel Sphincter<br />

• 30 % failed SNS<br />

• Congenital<br />

malformation<br />

• Absent sphincters<br />

• Significant loss of<br />

tissue due to injury


• N=52 1996-2010<br />

• F/U 64 +/- 46.5 mos<br />

Results of ABS<br />

• 26 (50%) required revision (most due to<br />

microperforation)<br />

• 14 (26.9%) definitive explantation (43% due to<br />

infection)<br />

• 35 with active device: fecal incontinence score<br />

(p


Artificial Sphincter: Complications<br />

• Range from 23-67%<br />

• Infection/perineal wound problems<br />

• Mechanical failure<br />

• Difficult evacuation<br />

• Still about 30% after learning curve<br />

Wong 1996, Lehur 1997, Vaizey 1998,<br />

Savoye 2000, Lehur 2002, O’Brien 2004


Change in <strong>Fecal</strong> <strong>Incontinence</strong> with ABS:<br />

Lehur<br />

1998<br />

Altomare<br />

2001<br />

Devasa<br />

2002<br />

O’Brien<br />

2004<br />

Using Wexner Score<br />

n preop postop % change<br />

13 17 4.5 74%<br />

28 14.9 2.6 83%<br />

53 17 4.0 74%<br />

14 19 4.8 89%


Antegrade Colonic Enema (ACE)<br />

• 1990 Malone<br />

– for children with neurogenic<br />

disorders<br />

• Continent conduit for intermittent<br />

catheterization<br />

– Appendix/ cecum/ ileum/<br />

descending colon<br />

• Irrigation of the colon and rapid and<br />

controlled large bowel purging<br />

• Does not preclude other future surgery


Antegrade Continence Enema<br />

• 10 adults F/U 17 mos; 80%<br />

significant reduction in FI<br />

episodes<br />

Malone 1990; Krogh 1998


<strong>Fecal</strong> <strong>Incontinence</strong>: Stoma<br />

• For patients who have failed<br />

or are not candidates for<br />

other surgical repairs<br />

• Old treatment, but can be<br />

done via a minimally<br />

invasive approach<br />

• Allows opportunity to leave<br />

home, attend work, and<br />

social functions


<strong>Fecal</strong> <strong>Incontinence</strong>: Future<br />

Magnetic anal encirclement Mesh sling of anus


Posterior Tibial Nerve Stimulation<br />

• First work for FI from Shafik<br />

in 2003 (Eur Surg Res)<br />

• Last 7 yr 7 other studies, all<br />

from Europe total 129 pts<br />

• All failed conservative tx<br />

• Heterogenecity in study pts,<br />

methodology, and outcomes<br />

Findlay et al Int J Colorectal Dis 2011;<br />

Leroi et al Am J Gastroenterol 2012


Posterior Tibial Nerve Stimulation<br />

• All tx protocols vary duration,<br />

timing, electrical frequency<br />

but all utilize portable external<br />

pulse generator<br />

• Current to post tib nerve<br />

proximal to medial malleolus<br />

with needle or adhesive<br />

electrode<br />

Findlay et al Int J Colorectal Dis 2011


Posterior Tibial Nerve Stimulation<br />

PTNS protocols:<br />

• Alt day 20 Hz for 30 min<br />

• Daily 10 Hz for 20 min<br />

• Weekly 20 Hz for 30 min<br />

• Twice wk 20 Hz for 30 min<br />

• Twice day ?? Hz for 20 min<br />

Findlay et al Int J Colorectal Dis 2011


90<br />

80<br />

70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

Shafik<br />

'03 n=32<br />

Summary PTNS trials<br />

achievement of primary endpoint<br />

Queralto<br />

'06 n=10<br />

Mentes<br />

'07 n=2<br />

Vitton<br />

'09 n=12<br />

De la<br />

Portilla<br />

'09 n=16<br />

Govaert<br />

'09 n=22<br />

Boyle<br />

'10 n=31<br />

Findlay<br />

'10 n=13


<strong>Fecal</strong> <strong>Incontinence</strong>: Treatment<br />

• Optimal treatment regime may<br />

be complex and tailored<br />

combination of various surgical<br />

and non-surgical treatment

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