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.

SNS TherapyStaged Procedure

• Electrode in S3

• Test stimulation 7 -14 days

• Implantation

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.