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