5. Fecal Incontinence-
More Common Than You Might Think
● It is estimated that more than 18 million adults in the United States
● 1 in 12 suffer from fecal incontinence (FI)
● FI is nearly as prevalent as many other chronic diseases and more
prevalent than other illnesses well-known to impact many Americans
0
5
10
15
20
25
30
35
OAB Asthma Diabetes FI Osteoporosis Alzheimer's
6. FI Impacts Quality of Life
Fecal Incontinence Quality of Life Scale (FIQOL) Scores
Note: Higher scores translate to higher quality of life
20. Factors associated with ABS failure
♦ 51 ABS in 47 patients
♦ Mean age: 48.8 years
♦ Mean Wexner score: 18 (0-20)
♦ Etiology of incontinence:
● Imperforate anus: 24 (54%)
● Obstetric injury / anorectal surgery: 15 (24%)
● Other: 12 (22%)
Wexner et al. DCR. 2009
21. Factors associated with ABS failure
♦ Infection 23 (41%)
♦ Non significant factors on univariate analysis:
● Age
● Gender
● BMI
● Diabetes Mellitus
● Etiology
● Stoma
● Perianal infection / surgery
Early 18
(35%)
Late 5
(6%)
Wexner et al. DCR. 2009
22. Factors associated with ABS failure
♦ Multivariate analysis:
♦ Time between ABS implantation to 1st
bowel
movement
♦ History of perianal sepsis
♦ Late failures
● More often due to device malfunction
● Indicated the need for mechanical refinement
Wexner et al. DCR. 2009
24. Sacral Neuromodulation
An established therapy
that expands your
treatment options for
patients with chronic fecal
incontinence who have
failed or are not candidates
for more conservative
treatments.
26. Sacral Neuromodulation
Mechanism of action
♦ Focuses mild electrical pulses on
the nerves that control the pelvic
floor muscles, anal sphincters, and
colon
♦ Either an excitation of
parasympathetic nerves or a
release from the inhibition of the
sympathetic nerves (or both) may
be hypothesized
27. Author n F/U (months) Scoring Method Before After p
Malouf (2000) 5 16 Wexner 16 2 <0.01
Ganio (2001) 16 15.5 Williams 4.1 1.25 0.01
Leroi (2001) 6 6 FI episodes/ 1wk 3.2 0.05 < 0.05
Matzel (2001) 6 5-66 Wexner 17 2 NR
Rosen (2001) 16 15 FI episodes/3 wks 6 2 NR
Kinefick (2002) 15 24 FI episodes/1 wk 11 0 <0.001
Jarrett (2004) 46 12 FI episodes/1 wk 7.5 1 <0.001
Matzel (2004) 34 24 FI episodes/1 wk 16.4 2.0 <0.0001
Rasmussen (2004) 45 6 Wexner 16 6 <0.0001
Uludag (2004) 75 12 FI episodes/1 wk 7.5 0.67 <0.01
Holzer (2007) 29 35 FI episodes/3 wks 7 2 0.002
Hetzer (2007) 37 13 Wexner 16 5 <0.01
Sacral Nerve Stimulation Results
36. Additional Study Measures
Self-rated Bowel Health
Wexner et al. Ann Surg. 2010
Mean Plot of Changes in Self-rated Bowel Health
7.28
3.53
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00
Baseline 12-Months
Mean Change from Baseline to 12 Months (n=106)
Self-ratedBowelHealth
(p < .0001)
37. Morbidity
Most Frequent Device/Therapy-Related
Adverse Events
Wexner et al. Ann Surg. 2010
♦ Test Stimulation Phase (n=132)
● Implant site pain (3.8%)
● Lead fracture (1.5%)
♦ Implant Phase (n=120)
● Implant site pain (25.8%)
● Implant site infection (10.8%)
● Paraesthesia (10.8%)
● Change in sensation of stimulation (5.8%)
● Diarrhea (5.8%)
● Pain (5%)
● Urinary incontinence (5.0%)
38. Morbidity
Infectious complications
♦ 13 women
♦ Mean age of 54.5 years (33-85)
♦ Mean BMI of 26.4 kg/m2
(19.3-39)
♦ One patient with non-insulin dependant
diabetes
♦ Two patients had lower back surgery
♦ No steroid use
Wexner et al. Ann Surg. 2010
Patients with infectious complication (n=13)
39. Morbidity
Infectious complications
Risk Factor No. of patients
Age > 65 4
BMI > 30 3
BMI > 35 2
NIDDM 1
Lower back surgery 2
Steroid use 0
Patients with infectious complication (n=13)
Wexner et al. J Gastrointest Surg 2010
40. Morbidity
Infectious complications
Implant Phase (n=120)
Early events
6 infections were reported at a mean of 11
(range 7-18) days post implant and
successfully treated with oral antibiotics
Wexner et al. Ann Surg. 2010
41. Morbidity
Infectious complications
Implant Phase (n=120)
Late events
7 infections were reported at a mean of 7 (range 2-14)
months after implant. 6 were totally or partially
explanted, 1 successfully re-implanted
Wexner et al. Ann Surg. 2010
43. SNS Long-term efficacy & Safety
120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
44. SNS Long-term efficacy & Safety
120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
45. SNS Long-term efficacy & Safety
120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
Significant improvement (p< 0.0001) in all 4 scales of the FIQOL from baseline to 3 years
46. SNS Long-term efficacy & Safety
120-Patient Prospective Multi-center Study
Mellgren et al. DCR 2011
♦ Common adverse events:
● Pain: 28%
● Infection: 11%
● Paraesthesia: 14%
47. SNS for Fecal Incontinence:
Long-term durability
Prospective Multi-center Study
Hull et al. DCR 2012
♦ Mean Follow-up: 60.4 (2.2 – 99.2) months
♦ 74 patients available at 5 year follow-up
♦ ↓ FI episodes (p<.001):
● 9.4 episodes/week at baseline
● 1.7 episodes/week at 5 yrs
♦ 88% had success (≥ 50% improvement) (p<.001)
♦ 36% had complete continence
♦ FIQOL scores also significantly improved for all 4
♦ scales between baseline and 5 yrs (p<.001)
48. SNS Six Year Follow-Up
The Danish Experience
Michelsen et al. DCR 2010
♦ 2001 - 2007
♦ 177 patients underwent PNE test
♦ Reasons FI (SNS implanted):
● 46.0% idiopathic
● 25.4% traumatic or obstetric
● 11.1% anorectal surgery
● 17.5% others
♦ 126 had SNS implanted
49. SNS Six Year Follow-Up
The Danish Experience
Michelsen et al. DCR 2010
♦ Permanent lead in S3: 105 patients
♦ Permanent lead in S4: 21 patients
♦ Explantation: 15 out of 126 (12%)
● Decrease function: 11
● Infection: 2
● Technical failure: 1
♦ Explantation: Median time 357 (24-1238) days
50. SNS Six Year Follow-Up
The Danish Experience
Michelsen et al. DCR 2010
Median Wexner incontinence score through the follow-up period
p< 0.001 for 3 and 6 months, and 1, 2, 3, 4 and 6 years. p<0.001 for 5 years
51. SNS Long-term results
10 years Follow-up
Matzel et al. Colorectal Dis 2009
♦ 1994 - 1999
♦ 9 patients
♦ Mean follow-up 9.8 (7-14) years
♦ Median number of incontinent episodes/week: 9 to 0
♦ Median Wexner score: 17 to 10
♦ Quality of life improved in all categories
♦ Pulse generator exchange was required in 8/9 at
mean of 7.4 yrs
♦ Complications: 4/12 (33%)
● Pain (2)
● Displacement (1)
● Urinary retention (1)
52. SNS and Sphincter Defect
Systematic Review
Ratto et al. Colorectal Dis 2012
♦ 10 studies (119 patients) met inclusion criteria
● 9 retrospective
● 1 prospective
♦ Definitive implant in 106 patients (89%)
♦ Follow-up: 22.9 (4.5-46) months
53. SNS and Sphincter Defect
Systematic Review
Ratto et al. Colorectal Dis 2012
Significant findings:
♦ Wexner Fecal Incontinence Score: 16.5 to
3.8
♦ Incontinent episodes per week: 12.1 to 2.3
♦ ↑ Ability to defer defecation
♦ ↑ Fecal Incontinence Quality of life Scale
♦ No change in anorectal manometry
54. SNS for fecal incontinence associated with
other specific conditions
Indication
Author/
Year
Patients
(n)
Improved
Outcomes
(Wexner FI, Number
incontinent episodes, QOL)
Rectal Resection Holtzer 2008 7 71%
Rectal Resection De Miguel 2010 7 100%
Rectal prolapse surgery RobertYap 2010 11 100%
Pelvic floor injury Oom 2010 29 86%
Radiation Maeda 2010 7 83%
Spinal cord injury Lombardi 2010 37 59%
56. What’s Next for Patients?
Consider InterStim
Therapy to those
patients who aren’t
responding
favorably to
medical therapy.
57. Overview of Trial Assessment
● Through a minimally invasive procedure initiated in the office or in
an outpatient hospital setting, a lead (thin wire) is placed near the
sacral nerve (target S3)
● The lead is connected to an external test stimulator worn on
the patient’s waistband for several days.
● The patient will be asked to record bowel behavior during
the trial
● If patient experiences success, a neurostimulator may be
implanted
● If patient does not experience success, a subsequent trial
assessment may be recommended
● If patient still does not experience success, the lead will be
removed and the patient will immediately be able to try other
options
58. ImplanterReferring Physician ImplanterReferring PhysicianReferring Physician
Collaborative
Process to
Optimize
Patient Care
Initial
Diagnosis
Initial
Diagnosis
Conservative
Treatments
Conservative
Treatments
ReferralReferral
InterStim
Implant
InterStim
Implant
Device-related
Follow-up
Ongoing General
Patient Care
Ongoing General
Patient Care
InterStim
Trial Assessment
InterStim
Trial Assessment
Benefits of Referring Your Patients
● Practical and extensive
experience with InterStim Therapy
● Offering your patients
a minimally invasive option
that can restore function1
● We will collaborate
to develop a
follow-up plan
once symptoms
are successfully
treated
59. What Should You Tell Your Patients?
♦ “I would like to refer you to a specialist who will
evaluate your condition further and determine if InterStim
Therapy might be an option for you”
♦ “The InterStim trial assessment will give you a chance to
find out during a short trial period if long-term therapy
may be a good option for you”
♦ “InterStim Therapy is an established therapy that is FDA
approved for chronic fecal incontinence patients who have
not benefited from conventional therapies”
60. Summary
♦ Fecal incontinence (FI) is very common and may impact
a person’s quality of life
♦ Patients may be embarrassed to discuss FI symptoms and
are often unaware of the new treatment options available
♦ If conservative treatments have been unsuccessful, refer
patients to my practice to determine if InterStim Therapy is
an option for them
♦ By partnering, you can expand patients’ treatment
options and help find the best solution to manage their
symptoms
♦ Together we can improve the quality of life for patients
with bowel control problems
61. Cutting Edge Colorectal Surgery
♦ TEM (Transanal Endoscopic Microsurgery)
♦ Total Laparoscopic Surgery
♦ Robotic Surgery
♦ Gracilis flap for recto-vaginal/recto-urethral fistulas
63. Rectal Cancer: Treatment Options
TEM Local Excision
Removal some node bearing
tissue
Disc excision of the
rectal wall
Lower recurrence rates (2-
10%)
Higher recurrence rates (up
to 25%)
Better staging ? Staging
64. TEM
Just another local excision?
• What’s so special?
Optimal visualization
3D Image
Balanced insufflation
Access to mid and upper rectum
Potential for lymphadenectomy
66. Total Laparoscopic Surgery
♦ Decrease in wound size
♦ Reduction in wound infection, dehiscence,
bleeding, herniation and nerve entrapment
♦ Decrease in wound pain
♦ Improved mobility
73. Gracilis flap for recto-vaginal/recto-urethral fistulas
♦ A viable option for repairing RVF and RUF,
especially after failed perineal or transanal repair
♦ It is associated with low morbidity and good success
rate
