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Sacral Neurostimulation reasonable to treat
chronic Idiopathie constipation
Ghislain DevroedeDépartement de chirurgieFaculté de médecine et des Sciences de la SantéUniversité de SherbrookeQuébec, Canada
QUALITY OF LIFE IS MARKEDLY
IMPROVED IN PATIENTS WITH
FECAL INCONTINENCE AFTER SACRAL
NERVE STIMULATION
*SNS STUDY GROUP(in alphabetical order)
The SNS Study Group included the following members (in alphabetical order): Jennifer M. Ayscue, MD, Washington Hospital Center, Washington, DC; Miranda Chan, MD, Department of Surgery, Kwong Wah Hospital, Hong Kong SAR, China; Heidi Chua, MD, Mayo Clinic, Rochester, MN; John A. Coller, MD, Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, MA; Ghislain Devroede, MD, Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Fleurimont, Canada; Michael England, MD, Norman F. Gant Research Foundation, Forth Worth, TX; Tracy Hull, MD, Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, OH; Howard Kaufman, MD, Division of Colorectal Surgery, University of Southern California, Los Angeles, CA; Robert D. Madoff, MD, Division of Colon & Rectal Surgery, University of Minnesota, MN; David Margolin, MD, Department of Colon & Rectal Surgery, Ochsner Clinic Foundation, New Orleans, LA; Richard McCallum, MD, University of Kansas Medical Center, Kansas City, KS; Anders Mellgren, MD, PhD, Division of Colon & Rectal Surgery, University of Minnesota, MN; Ece Mutlu, MD, Rush University Medical Center, Chicago, IL; Deborah Nagle, MD, Colon and Rectal Surgical Division, Beth Israel Deaconess Medical Center, Boston, MA; Susan Parker, MD, Division of Colon & Rectal Surgery, University of Minnesota, MN; Paul Pettit, MD, Mayo Clinic, Jacksonville, FL; Abbas S. Shobeiri, MD, University of Oklahoma, Oklahoma City, OK; William J. Snape, MD, California Pacific Medical Center, San Francisco, CA; Joe Tjandra, MD (Late), Royal Melbourne Hospital, Victoria, Australia; Steven D. Wexner, MD, Department of Colorectal Surgery, Cleveland Clinic Florida, FL.
Sacral Nerve Stimulation (SNS)
• SNS usually stimulates S3
• 1994 Europe- Chronic pelvic and lower urinary and intestinal tract disorders
• 1997/1999 USA- UI / UF and Retention
• 2011 USA- Chronic fecal incontinence
Note: FDA's approval is based solely on 12-month data.
Sacral nerve stimulation for fecal incontinence
______________________________________________________
North American SNS Study Group(FDA Approved Protocol)
• Informed consent : 285
• Test stimulation : 133 (152 rejected by inclusion /
(tined lead electrode) exclusion criteria)
• Interstim Device : 120 (47%)
• Follow up (years) : 5 (0.2 – 7.0)
Frequency of incontinent episodes or days per week
0
1
2
3
4
5
6
7
8
9
10
0 12 24 36 48
Follow-up Months
Mea
n w
eekl
y in
cont
inen
t ep
isod
es o
r day
s
Weekly Incontinent Episodes Weekly Incontinent Days
(follow-up to baseline : P < .001)
3 6
Percent of patients with >50% improvement in incontinent episodes per week
42% 48% 46%
41%38% 40% 40%
47%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 (n=106)
24(n=73)
26(n=77)
48(n=77)
Follow-up Months
Per
cen
t o
f P
atie
nts
100% Improvement
>50% Improvement
Fecal incontinence severity index assessment (FISI)
0
10
20
30
40
50
60
0 12 24 36 48
Follow-up Months
Mea
n F
ISI
Sco
res
FISI - Patient Weighting FISI - Surgeon Weighting
(follow-up to baseline : P < .001)
3 6
Fecal incontinence quality of life assessment (FIQOL score)
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
0 12 24 36 48
Follow-up Months
FIQ
OL
Mea
n S
core
s
Scale 1 - Lifestyle Scale 2 - Coping/Behavior
Scale 3 - Depression/Self-Perception Scale 4 - Embarrassment
(follow-up to baseline : P < .001)
3 6
Score improvement for each question of the FIQOL
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
Baseline 48 months
Me
an
Sc
ore
Note: Question 1 rating “general state of health” has a reverse scale, with 1 being “Excellent” and 5 being “Poor”. The other questions use a scale of 1-4, with 1 being worse and 4 being best.
Individual QOL questions at baseline and 48 months
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
I have sex less often than I w ould like to
I am afraid to have sex
I feel ashamed
I avoid staying overnight aw ay from home
I avoid visiting friends
I avoid traveling by plane or train
I am afraid to go out
I cut dow n on how much I eat before I go out
I try to prevent bow el accidents by staying very near abathroom
I leak stool w ithout even know ing it
I plan my schedule around my bow el pattern
I use protective pads
Percent of Patients Answering "All/Most of the Time"
Baseline
48M
Improved quality of life after sacral neurostimulation for fecal incontinence
FOOD : Amount
Restaurants
SOCIAL : Going out (movies, church,
friends)
Staying overnight
away from home
Traveling (trains, plane)
(ALL P < 0.001)
n = 120
Improved quality of life after sacral neurostimulation for fecal incontinence
INTIMACY : Less frequent sexual encounters than wished
Fears of sexual encounters
FEELINGS : DifferentNot enjoying life
Ashamed
Depressed
(ALL P < 0.001)
n = 120
Sacral nervestimulation or modulation ?
We know for sure that we stimulate :
Variables : - sacral root
- body side
- voltage
- frequency
- sensation site (anus, perineal body, vulva)
- anal contraction; toe movement
We do not know what we modulate
There is focal brain activationduring sacral nerve stimulation
(L. LUNDBY, A. MOLLER, S. BUNTZEND, K. KROGH, K. VANG, A. GJEDDE, S. LAURBERG, Diseases of the Colon & Rectum 2011; 54; 318-323)
Sacral neurostimulationThe Sherbrooke experience
Percutaneous nerve stimulation (PNS) : 81
(extended PNE to 7 - 14 days) (2 sides = 162 PNEs)
Interstim sacral nerve stimulation (SNS) : 68
(AS OF 1/12/2012)
The ghost of my mother______________________________________________________
RC : Fecal incontinence by pudendal neuropathy
(no effective treatment)
Preoperative decision : 2-2-2005 Wexner 17/20
Anal electromyography : Pudendal neuropathy (EAS/PR)
Functional rectal examination : Pudendal neuropathy
Interstim implant : 29-3-2005 Wexner 0/20
SNS Off : 26-4-2010 Wexner 0/20
No visit for one year
SNS Out : 23-11-2012 Wexner 0/20
Suzanne L.
The ghost of my mother______________________________________________________
« My mother never loved me »
BIRTH : Her mother gives her in adoption
Her father brings her back home
ORPHAN OF HER FATHER
ORPHAN OF HER MOTHER : She is disinherited
21/9/2011 : « Don't say I'm crazy »
«The corpse of my dead mother came into my
bed. My guardian angel, at the ceiling told me
I was cured. »
SNS OFF Goes to the Dominican Republic
Goes to Mexico
No fecal incontinence
23/11/2012 : Interstim removed
Suzanne L.
Risk factors for female fecal incontinence
5
BHARUCHA 2006
n = 5300
AGE(per decade)
IBS DIARRHEA ANAL FISTULA
URGENCY(NO DIARRHEA
NO CONSTIPATION)
VAGINAL DELIVERY FORCEPS STITCHES
ODDSRATIOS
A NEAR MISS______________________________________________________
WEXNER SCORE
FIRST VISIT 18/20
SECOND VISIT 11/20
THIRD VISIT 4/20
(dismissed) (daily clean pads)
Pauline D.
A NEAR MISS______________________________________________________
Pregnant mother, dying father (Hodgkin’s disease)
9 months old : Death of father
Maternal grandmother : Accuses her daughter-in-law
of having « killed » her son
____________________________
“You were like a strong wind opening a door widely”
“I knew for a long time I was mother to my mother”
“You told me she was more attached to me,
and needing me, than loving me”
Pauline D.