A Case of Fecal Incontinence:

Medical and Interventional

Treatment Options

HPI

• JP is a 69 year-old F with a 12-month history of FI. Her symptoms began after a colonoscopy

• She has been experiencing passive “accidents” 3-4x/week consisting of the loss of 1.5 teaspoons -1/4 cup of pasty Bristol 5 stool

• She denies urge, stress, and overflow components. She is passing 1 Bristol 4 BM daily

HPI

• Obstetric History;

– 2 vaginal deliveries

– (+) episiotomies with each delivery

– No acute episodes of FI

• Prior Diagnostics:

– Colonoscopy x2Normal

• Prior Therapeutics:

– PEG 3350 taken on an intermittent basis

• PMH: GERD, Hyperlipidemia

• PSH: Ventral hernia repair

• Meds: Zocor, Prilosec

• Allergies: Sulfa

• FHx: (-) GI disorders/malignancies

• SHx: Widowed, RN, (-) tobacco/ETOH

• ROS: 10/14 (-)

Physical Exam

• General Exam: No abnormalities

• External perianal exam: (-) EH; (-) fissures/fistulae

(-) excoriations/rashes; (+) anal wink

(+) appropriate descent (-) prolapse identified

• DRE: (+) weakened resting tone and squeeze pressure,

normal strain maneuver, no stool palpated

JP: Resting Pressure

Normal Weak

IAS Function

IAS Function

Changes concerning for passive incontinence

JP: Maximum Squeeze Pressure

Changes concerning for urge incontinence

Normal Weak

EAS Function EAS Function

History Continued:

What treatment options

are available for JP?

Non-pharmacologic Management of

Fecal Incontinence

Intervention Mechanism of Action

Incontinence pads/Cotton

balls/Butterfly pad

Provides skin protection; prevents soiling; conduct

moisture away from skin

Anal plugs Provides a barrier to fecal incontinence; can be

difficult to tolerate. Type can impact performance

Enemas Voluntarily and selectively evacuates rectum

Anorectal biofeedback

Improves rectal sensation and compliance;

coordinates external anal sphincter contraction; may

increase anal sphincter tone

Whitehead WE, Bharucha AE. Gastroenterology. 2010;138:1231-1235.

Deutekom M, Dobben AC. Plugs for containing faecal incontinence.

Cochrane Database of Systematic Reviews 2012, Issue

4. Art. No.: CD005086. DOI: 10.1002/14651858.CD005086.pub3.

Long-term Results of Biofeedback for

Solid Stool Fecal Incontinence

38

48.1

11.4

2.5

12.5 12.5

22.5

52.5

0

10

20

30

40

50

60

Biofeedback

No treatment

Assessed @

1,6,36,60 MONTHS

Perc

en

tag

e

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.

Pharmacologic Management of

Fecal Incontinence

• Anti-diarrheals

• Tricyclic antidepressants

• Bile acid binding resins

• Topical phenylephrine gel

No pharmacologic treatments have been adequately evaluated in large,

randomized, controlled studies in patients with fecal incontinence

History Continued:

• Based on ARM findings JP referred to the Rehabilitation Institute of Chicago for PFPT/BF

• She undergoes 6 sessions of PFPT/BF but decides to stop because she finds it ineffective

• What other options are available?

– Injectable bulking agents

– Sacral Nerve Stimulation (SNS)

Cochrane: Injectables for

the Treatment of FI

5 trials: • Silicone biomaterial

• Collagen

• Carbon-coated microbeads

• Dextranomer-hyaluronic acid

Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane

Database of Systematic Reviews 2013, Issue 2. Art. No.: CD007959. DOI: 10.1002/14651858.CD007959.pub3.

One large randomized controlled trail has shown that this form of treatment using dextranomer in

stabilized hyaluronic acid (NASHADx) improves continence for a little over half of patients in the

short term. However, the number of identified trials was limited and most had methodological

weakness.

Injectable Bulking Agents for FI

• Biocompatible gel of dextranomer microspheres in hyaluronic acid (Solesta®)

• Administration

– Done in physician office or hospital outpatient department w/o anesthesia

– Four 1 cc injections through an anoscope into submucosal layer of the anal canal

– Bulks and approximates anal mucosa closing anal canal or increasing pressure

• 2011:FDA-approved for the treatment of fecal incontinence in patients aged ≥18 years who have failed conservative therapy

Solesta [package insert]. Oceana Therapeutics, Edison NJ, 2012. Accessed April 1, 2013

at: http:www.solestainfo.com/pdf/solesta-pi.pdf

NASHA Dx

0%

10%

20%

30%

40%

50%

60%

Solesta Sham

52%

31%

50% Decrease in FI episodes @ 6 months

Solesta

Sham

N=136

N=70

p=0.0089

NNT=5

.

Graf W et al. Lancet. 2011; 377: 997–1003.

Secondary Endpoints: Decrease in FI

Episodes After Solesta® Treatment

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

Baseline3 months

6 months9 months

12 months

15.0

8.6

7.3 7.0

6.2

P<0.0001 @ 12 MONTHS

Med

ian

nu

mb

er

of

ep

iso

des/1

4 d

ays

Pro

po

rtio

n r

esp

on

ders

.

Graf W et al. Lancet. 2011; 377: 997–1003.

NASHA Dx: Improvement

in Number of FI-Free Days

0

2

4

6

8

10

0 3 6 9 12

Mea

n n

um

ber

of

FI-

free

days o

ve

r

14 d

ays

Months since treatment

Almost 2-fold increase (4.4 to 7.8 days) of incontinence-free days1

1. Graf W et al Lancet. 2011; 377: 997–1003.

NASHA Dx: 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%) —

Others 22 (16%) 5 (7%)

*Serious adverse events

Graf W et al. Lancet. 2011; 377: 997–1003.

NASHA Dx: Long-Term Efficacy

54.00%

55.00%

56.00%

57.00%

58.00%

59.00%

60.00%

61.00%

62.00%

63.00%

12 Months 24 Months

57.40%

62.70%

% R

espond

ers

Open-Label 12 & 24 Month Follow-UP

Responder defined as >50 % reduction in FI episodes

Solesta [package insert]. Oceana Therapeutics, Edison NJ, 2012. Accessed January 1, 2014 at: http:www.solestainfo.com/pdf/solesta-

pi.pdf; La Torre F et al. Colorectal Dis 2013;15(5):569.

Sacral Nerve Stimulation

(SNS) System

1. Tined lead is placed parallel to

the sacral (S2, S3, or S4)

nerve

2. Neurostimulator generates

electrical pulses delivered

through the leads

3. Clinician and patients set the

parameters of the electrical

pulses

4. FDA approved 2011 1

2

3

InterStim II Neuromodulator [manual]. Medtronic, Inc. Minneapolis, MN. 2012.

SNS Placement

Sacral Nerve Stimulation System:

Bowel Control Study

38.9 39.3 40.6 37.3 40

29.2 31.8 28.3 34.3 36.7

16.8 17.8

14.2 13.4 10

8.9 7.5

9.4 7.5 10

6.2 3.7 7.6 7.5 3.3

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

<=0%

(0%, 50%)

(50%, 75%)

(75%, 100%)

100%

Perc

en

t o

f P

ati

en

ts

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

Wexner SD, Coller JA et al. Ann Surg. 2010;251:441-449.

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.

Cochrane: PFPT/BF/SNS for the

Treatment of FI

21 trials: 1525 patients

Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults.

Cochrane Database of Systematic Reviews 2012, Issue 7. Art. No.: CD002111. DOI: 10.1002/14651858.CD002111.pub3.

The limited number of identified trials together with methodological weakness of many do not allow a

definitive assessment of the role of anal sphincter exercises and biofeedback therapy in the management

of people with faecal incontinence. We found some evidence that biofeedback and electrical stimulation

may enhance the outcome of treatment compared to electrical stimulation alone or exercises alone.

Exercises appear to be less effective than an implanted sacral nerve stimulator. While there is a

suggestion that some elements of biofeedback therapy and sphincter exercise may have a therapeutic

effect, this is not certain. Larger well-designed trails are needed to enable safe conclusions

History Completed:

• Risks, benefits, and contraindications of interventional procedures discussed

• JP chooses Solesta® as initial intervention and this is injected without complications

• 3 months later she continues to experience significant improvement

– Mild leakage 1-2x/week

– 1 cc of liquid stool in her undergarment

• Barrier devices recommended PRN

Review: Treatment Options for

Fecal Incontinence

Pharmacology/Non-pharmacological

Interventions

Dextranomer Microsphere

Injections

SNS

Other Surgical Interventions

Least Invasive

Most Invasive

Decision based on

balance between risk

& likelihood of

positive outcome