fecal incontinence - defecatory disorder center · fecal incontinence (fi) is defined as either the...

FECAL

INCONTINENCE

John H. Winston, III, M.D., M.B.A.

Diplomate, American Board of Colon & Rectal Surgery

Diplomate, American Board of Surgery

www.colorectalsurgeryservices.com

Fecal Incontinence (FI) Is Defined as Either the Involuntary

Passage or the Inability to Control the Discharge of Stool1

• There are 3 subtypes of FI1:

– Passive incontinence: The involuntary discharge of stool or gas without

awareness

– Urge incontinence: The discharge of fecal matter in spite of active attempts to

retain bowel contents

– Fecal seepage: The leakage of stool following otherwise normal evacuation

• Inability to defer the urge to pass gas or stool to a socially acceptable time

and place

– Leakage

– Staining or soilage of under garment

– Irritation

– Accidental loss of gas or bowel contents

2 1. Rao SS; ACOG Practice Parameters Committee. Am J Gastroenterol. 2004;99(8):1585-1604. 2. Jorge JM, Wexner SD. Dis Colon Rectum.

1993;36:77-97.

The Prevalence of FI Is Increased in the Elderly

• It is one of the most common reasons for entering a nursing home1

• 45% of nursing home residents have FI2

– 10% to 15% in the more independent residents

– up to 70% among the most dependent residents

• FI affects 16% of non-institutionalized adults aged 70 years and older1

3 1. Ditah I, et al. Clin Gastroenterol Hepatol. 2013;Jul 29. doi:10.1016/j.cgh.2013.07.020. [Epub ahead of print]. 2. Landefeld CS, et al. Ann Intern Med.

2008;148(6):449-458.

FI Affects Up to 19 Million People in the

United States (US)

4 1. Ditah I, et al. Clin Gastroenterol Hepatol. 2013;Jul 29. doi: 10.1016/j.cgh.2013.07.020. [Epub ahead of print]. 2. International Foundation for Functional

Gastrointestinal Disorders. Managing Incontinence: A survey of those who live with it. Milwaukee, WI, 2011.

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Prevalence Diagnosed

Mill

ion

s o

f P

eo

ple

(U

S)

Prevalence is 8.4% among

non-institutionalized adults

Mean age of

49 years

1 in 10 women

According to the US National Health and

Nutrition Examination Survey (NHANES):1

Studies suggest that only 15%– 45% of FI patients seek

treatment1,2.

Consider the following statistics that support the claim that

fecal incontinence is a hidden condition:

• For 84% of patients with FI, the physician was unaware of the patient’s

disorder1

• 54% of patients with FI had not discussed the problem with a professional2

• 65% of patients with severe or major FI which had an impact on the quality of

life wanted help with their symptoms3

1. Damon H, Guye O, Seigneurin A, et al. Prevalence of anal incontinence in adults and impact on quality-of-life. Gastroenterol Clin Biol.

2006;30(1):37-43

2. Edwards NI, Jones D. The Prevalence of Faecal Incontinence in Older People Living at Home. Age Ageing. 2001;30(6):503-7

3. Perry S, Shaw C, McGrother C, et al. Prevalence of faecal incontinence in adults aged 40 years or more living in the community. Gut.

2002;50(4):480-484.

Patient Education Needed

Don’t Be Embarrassed

• Bowel control problems can be upsetting and

embarrassing.

• Don’t be ashamed to discuss with your doctor.

• It is often due to a medical problem.

• There are treatment options!

WH-175304-AA. Slide 20 of 44. August 2013

National Institute of Diabetes and Digestive and Kidney Diseases. Fecal Incontinence,

http://digestive.niddk.nih.gov/ddiseases/pubs/fecalincontinence/index.aspx

Fecal Incontinence Quality of Life Scale (FIQOL) Scores

Note: Higher scores translate to higher quality of life

Medtronic data on file. InterStim Therapy for Bowel Control Prospective Clinical Study. PMA#P080025.

FI Impacts Quality of Life

UROGENITAL ANATOMY

• Levator ani

– Pubrectalis

– Iliococcygeus

– Pubococcygeus

• External sphincter

• Internal sphincter

• Urethral support system – Levator ani (puborectalis)

– Arcus tendineus fasciae pelvis

– Endopelvic fascia

– Paravaginal fascia

POSTERIOR

COMPARTMENT

ANTERIOR

COMPARTMENT

UROGENITAL ANATOMY

MECHANISMS OF

FECAL CONTINENCE

Colonic factors Stool volume

Stool consistency

Anorectal factors Capacity/compliance of rectum

Anal seal of vascular cushions

Muscular factors Sphincteric/pelvic floor function

Intact anal sphincter

Neurological factors Rectal sensation

Normal mentation

Intact innervation/reflexes

Problems likely due to

several causes

Treatment must be directed

at multiple causes

Fecal Incontinence Has Many Causes1,2

Traumatic Injury Obstetric, post-surgical, sexual, accidental

Pelvic Floor

Disturbances

Rectal prolapse, descending perineum syndrome, weakening

or dropping of pelvic floor due to age

Inflammatory

Conditions

Ulcerative colitis, Crohn’s disease, infectious colitis, radiation

proctitis, ischemic colitis

Neurological

Conditions

Dementia, stroke injury, multiple sclerosis, diabetes mellitus,

mental retardation, polyneuropathy, cauda equina lesions,

pudendal neuropathy

Diarrhea/

Constipation

Irritable bowel syndrome, lactose intolerance, laxative, bile

malabsorption, secretory diarrhea, impaction/overflow

11

1. Bharucha AE. Gastroenterol Hepatol. 2008;4(11):807-817. 2. Rao SS; ACOG Practice Parameters Committee. Am J Gastroenterol.

2004;99(8):1585-1604.

COMPONENTS OF WORKUP

• History & physical

• Labs/stool studies

• Radiology – Anal ultrasound – Anal MRI

– Defecography

– Barium enema

– Peritoneography

• Endoscopy – Total colonoscopy – Rigid sigmoidoscopy

– Flexible sigmoidoscopy

• Physiologic test – EMG

• Needle probe

• Surface

– Manometry – P.N.T.M.L. testing

– Peritoneometry

ANORECTAL LABORATORY

ANAL MANOMETRY:

Normal resting & contracture RECTAL

BALLOON

POSTERIOR

RIGHT

ANTERIOR

LEFT

MANOMETRY vs. ULTRASOUND:

Birth injury & sphincterotomy

DISTAL ANUS

PROXIMAL ANUS INTERNAL

SPHINCTER

EXTERNAL

SPHINCTER

MANOMETRY ULTRASOUND

6.0 cm

100.0

mmHg

5.0 cm

100.0

mmHg

4.0 cm

100.0

mmHg

3.0 cm

100.0

mmHg

2.0 cm

100.0

mmHg

1.0 cm

100.0

mmHg

Powell,Joan

Figure 3. Resting Tone Profile Vector Plot

Resting Tone

LeftRight

Ant

Post

5.0 cm

100.0

mmHg

4.0 cm

100.0

mmHg

3.0 cm

100.0

mmHg

2.0 cm

100.0

mmHg

1.0 cm

100.0

mmHg

Powell,Joan

Figure 4. Maximum Voluntary Contraction Profile Vector Plot

Maximum Voluntary Contraction

LeftRight

Ant

Post

Non-surgical Treatments

• Medicines:

– Soften stool (laxatives).

– Help form stool (antidiarrheal medicines).

– Treat systemic disease.

– Avoid causative medicines.

• Physical therapy (PT): – Improves the pelvic muscle strength, tone,

endurance and coordination.

– May include biofeedback.



Satish SCR. Practice Guidelines: Diagnosis and Management of Fecal Incontinence. American Journal of Gastroenterology, 2004.

Treatments – Medicines

Diet / fiber1

− Often helpful.

− Makes stools firmer.

− Promote more complete passage of bowel movements.

− Eat more whole grains, fruits, vegetables, or high fiber cereals.

− Ask your doctor about fiber supplements.

Stool softeners2

− Example: Colace®

Mechansism: Emulsify fat in GI tract and decrease reabsorption of water

Mechanism: Increase water content of stool

Colace® is a registered trademark of Roberts

Laboratories Inc., Mead Johnson & Company.

1. Rao S. Am J Gastroenterol. 2004 Aug;99(8):1585-604.

2. Halverson AL. Clin Colon Rectal Surg. 2005 Feb;18(1):17-21.

3. National Institute of Diabetes and Digestive and Kidney Diseases. Fecal Incontinence,


ARE THERE OTHER OPTIONS?

There are now successful surgical options.

There is no need to suffer any longer.

Be open with your doctor about symptoms.

Ask about seeing a specialist.

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Goals of Surgical Treatment

• The goal of surgery is to: • Improve bowel emptying.

• Improve bowel control.

• Improve bowel sensation.

• Help bowel emptying at appropriate times.

• Past procedures have had poor results

• Newer, more successful therapies are here!



Satish SCR. Practice Guidelines: Diagnosis and Management of Fecal Incontinence. American Journal of Gastroenterology,

2004.

Surgical Procedures- Sphincter Repair

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•Traditional procedure

•Can fix multiple problems at

same time

•Requires general anesthesia

•High complication rate

•Wound infection

•Worsening of incontinence

•Probably treats only one cause

•Results poor after 5 years

•Poor results have lead to search

for better treatments

Surgical Procedures

Anal sphincter repair1

Sacral nerve stimulation2

− First a test phase procedure

− Surgically implanted device if successful

Anal bulking agent injection

− In office

− No anesthesia and quick

Less frequently performed procedures

− Antegrade colonic enema

− Graciloplasty

− SECCA®

− Artificial sphincter

Colostomy or diversion

1. Halverson AL, Hull TL. Dis Colon Rectum. 2002.45:345-348.

2. InterStim® prescribing information. Medtronic, Inc. Secca® is a registered trademark of Mederi Therapeutics Inc.

Solesta® for the Treatment of Fecal Incontinence

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Solesta® Injectable Gel Is the Only FDA-approved Injectable Bulking Agent

Solesta is a biocompatible, injectable gel consisting of dextranomer microspheres in stabilized hyaluronic acid

Expands the top layer in the upper anal canal to improve bowel control

− Helps seal off anus

− Helps sense when stool enters rectum (my opinion)

A simple procedure

Recently arrived in USA

23

Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc.; 2014.

Administration of Solesta®

Administered as four small injections through an anoscope

Should only be administered by physicians experienced in performing anorectal procedures

Special training and certification needed.

Non-surgical

Outpatient procedure

No anesthesia required

Quick


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Baseline 6 12 36

Me

dia

n N

um

be

r o

f F

I e

pis

od

e / 1

4 d

ays

Me

an

Num

be

r o

f F

I-fr

ee

da

ys /

14

da

ys

FI-free days FI episodes

Solesta® Reduces FI Episodes With Significant Results in as Little as 6 Months1

Continued improvements were maintained over 36 months2,a

25

4.4

8.1 7.9 7.5

15.0

7.2 6.2 7.0

Almost a 2-fold increase

(4.4 to 8.1 days) in

incontinence-free days3

a P<0.001 for mean and median at each time point.

1. Graf W, et al. Lancet. 2011;377:997-1003. 2. Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc.; 2014. 3.

Mellgren A, et al. Neurogastroenterol Motil. March 2014.

53.2%

30.7%

0%

20%

40%

60%

80%

Solesta Sham

Re

sp

on

de

r 50 (%

)

P=0.004

N=206

Solesta® Demonstrated Superior Efficacy Compared to Sham

53.2% of patients in the Solesta group achieved a 50% or greater reduction in the number of incontinence episodes compared to baseline at 6 months

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Demonstrated Safety With Solesta® Over 24 Months

• The majority of problems were mild to moderate, self-limited and resolved within 1 month of the initial injection

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Most Commonly Reported Problems after the Procedure

Preferred term %

Proctalgia (rectal pain) 13.3

Pyrexia (fever) 9.6

Constipation 4.8

Injection site pain 4.8

La Torre, de la Portilla F. Colorectal Dis. 2013;15:569-574.

SURGICAL TREATMENT:

Sacral Neuromodulation for

Bowel Control

Sacral Nerve Stimulator

Recently approved in USA.

Like a pacemaker for your anus.

A simple two-stage procedure.

• Done in operating room.

• Requires postoperative adjustment.

• Low risk.

• Very effective

30

InterStim Therapy for Urinary Control and

Bowel Control An established therapy that expands

treatment options for patients with:

• urge incontinence,

• urgency-frequency,

• non-obstructive urinary retention,

• chronic fecal incontinence

who do not benefit from more

conservative treatments.

More than 100,000 patients worldwide

have received InterStim Therapy

InterStim Therapy Bowel Control Study

1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.

2. Medtronic-sponsored research. InterStim Therapy Clinical Summary - 2011.

0

1

2

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4

5

6

7

8

9

10

Mea

n N

um

be

r o

f W

eekl

y

Inco

nti

ne

nt

Epis

od

es

Per-protocol (completers) (n=106)

9.4 9.2

3.1

1.9

Modified Worst Case (MWC) (n=120)

Clinical Efficacy: Reduction in Episodes

InterStim Therapy for Bowel Control

Clinical Efficacy: Complete Continence

0

10

20

30

40

50

Perc

ent

of

Pati

ents

wit

h a

10

0%

R

edu

ctio

n in

Acc

iden

ts a

t 1

2 M

on

ths InterStim Therapy

Bowel Control Study1,2

Per-protocol

(n=106) MWC (n=120)

41%

36%

1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.

2. Medtronic-sponsored research : InterStim Therapy - Clinical Summary, 2011.

3. Tjandra JJ et al. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal

incontinence: a randomized, controlled study. Dis Colon Rectum. May 2008;51(5):494-502.

47%

Tjandra RCT3

SNS group

(n=53)

InterStim Therapy for Bowel Control

Adverse Events

• Pain at implant sites

• New pain

• Lead migration

• Infection

• Technical or device problems

• Adverse change in bowel or voiding function

• Undesirable stimulation or sensations

The most common problems after the procedure:

Any of these may require additional surgery or cause return

of symptoms.

Test for Potential Success

Basic Evaluation

• A temporary lead is placed during a simple

in-office procedure and connected to an external

stimulator

• You and your patient assess therapy effects in

as few as 3-7 days

• If successful, patient may proceed directly to

long-term lead and device implant through an

outpatient procedure

• If test is inconclusive or unsuccessful, the

advance evaluation via the staged test is

recommended

Test for Potential Success

• Utilizes a tined lead that anchors in place

• Placed in the OR during an outpatient procedure

• Patient assessed for up to 14 days

• With successful test results, the lead remains in place

and the device & lead extension (if applicable) are implanted

Complications can occur with the test procedure, including

movement of the wire, technical problems with the device, and

some temporary pain.

Advanced Evaluation

Complete InterStim System

1. Small wire is placed near the

sacral nerves.

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

2

Evaluating for InterStim: Treatment Algorithm

Initial Evaluation for

Fecal Incontinence

InterStim Implant

Conservative Treatment •Diet Modification & Fiber

•Medication

•/Physical Therapy/biofeedback

Continue as

Appropriate

InterStim Therapy

Test Evaluation

2nd

Test Evaluation

+ -

Other Surgical

Treatment

+

-

Support from Others

• Patients respond differently to treatments—work with

your doctor to find the best treatments for you.

• Patient story…

WH-175304-AA. Slide 26 of 44. August 2013

PFD Alliance. www.voicesforpfd.org.

• Fecal incontinence is common

• People do not talk about it

• Testing can be done

• There are treatments

• Treatments are simple

• Treatments are successful

• Talk to your doctor

Take Home Points

THANKS!

fecal incontinence - defecatory disorder center · fecal incontinence (fi) is defined as either the...

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