New Innovations in the New Innovations in the Surgical Management of Surgical Management of

IncontinenceIncontinenceGeriatric Grand RoundsGeriatric Grand Rounds

December 2December 2ndnd, 2011, 2011

Joshua I. S. Joshua I. S. BleierBleier,, MD, FACS, FASCRSMD, FACS, FASCRSAssistant Professor of SurgeryDivision of Colorectal Surgery

University of PennsylvaniaPhiladelphia PAPhiladelphia, PA

DisclosuresDisclosuresDisclosuresDisclosures

No financial relationships with industryNo financial relationships with industry Some slides provided by MedtronicSome slides provided by Medtronic Some slides provided by MedtronicSome slides provided by Medtronic

OutlineOutlineOutlineOutline

Is this a worthwhile topic?Is this a worthwhile topic? History/PhysicalHistory/Physical History/PhysicalHistory/Physical Evaluation Evaluation –– anorectal physiology labanorectal physiology lab

T t tT t t TreatmentTreatment New developmentsNew developments

Why should you care?Why should you care?Why should you care?Why should you care?

Affects 2Affects 2--7% of people7% of people

4040--50% of people in nursing homes; 50% of people in nursing homes; one of most common reasons forone of most common reasons forone of most common reasons for one of most common reasons for placement in a nursing homeplacement in a nursing home

More reasons to careMore reasons to careMore reasons to care…More reasons to care…

Social stigmaSocial stigma

Embarassment Embarassment –– pt’s stay confined to pt’s stay confined to their homestheir homestheir homestheir homes

Isolation/loss of self esteemIsolation/loss of self esteem

$$$$$$$$$$$$

In young people In young people –– loss of jobs/ loss of jobs/ dependence on welfaredependence on welfarepp

ElderlyElderly nursing home admissionnursing home admission Elderly Elderly –– nursing home admission nursing home admission costs are high. Buying diapers/pads; costs are high. Buying diapers/pads; treatment of depressiontreatment of depressiontreatment of depressiontreatment of depression

Stool ContinenceStool ContinenceStool ContinenceStool Continence

Compliance andCompliance andreservoir functionreservoir function

Stool Stool consistencyconsistency

COLONCOLON

RECTUMRECTUM

ANUSANUS

MotorMotorSensorySensory

Types of incontinenceTypes of incontinenceTypes of incontinenceTypes of incontinence

FlatusFlatus Liquid StoolLiquid Stool Liquid StoolLiquid Stool Solid StoolSolid Stool

Partial incontinencePartial incontinence SoilingSoiling

Bowel HabitBowel HabitBowel HabitBowel Habit

DiarrheaDiarrhea IBSIBS IBSIBS UrgencyUrgency

S it f I tiS it f I ti Severity of IncontinenceSeverity of Incontinence Awareness of stool passage?Awareness of stool passage? Diarrhea or constipation promoting RxDiarrhea or constipation promoting Rx

HistoryHistoryHistoryHistory

Sexual historySexual history ObstetricObstetric HistoryHistory Obstetric Obstetric HistoryHistory GYN History GYN History

P iP i ll hi thi t Previous Previous prolapseprolapse historyhistory Neurologic disordersNeurologic disorders Surgery Surgery –– large/small bowel resectionlarge/small bowel resection RadiationRadiation RadiationRadiation

Fecal IncontinenceFecal IncontinenceSphincter Injury at DeliverySphincter Injury at Delivery

33--9% of deliveries9% of deliveries

Primary repairPrimary repairFecal incontinence 20%Fecal incontinence 20%Fecal incontinence 20%Fecal incontinence 20%

CausesCausesCausesCauses

CongenitalCongenital Pelvic floor Pelvic floor denervationdenervation Radiation Radiation –– ¾ pts receiving pelvic radiation ¾ pts receiving pelvic radiation

experience acute experience acute anorectalanorectal symptoms; up to symptoms; up to 20% late phase 20% late phase proctitisproctitis; 5% disabling ; 5% disabling symptomssymptoms

Iatrogenic; Iatrogenic; ieie 3030--50% after LIS; also 50% after LIS; also occurs after non sphincter cutting occurs after non sphincter cutting operationsoperations

CausesCausesCausesCauses

Traumatic Traumatic –– Obstetric Injury / Obstetric Injury / EpisiotomyEpisiotomyp yp y

Majority of elderly women with Majority of elderly women with incontinence present with delayedincontinence present with delayedincontinence present with delayed incontinence present with delayed symptoms DECADES after injurysymptoms DECADES after injury

PhysicalPhysicalPhysicalPhysical

Abdominal Abdominal –– check for scarscheck for scars

Is there a pad in placeIs there a pad in place??C f l GYN EC f l GYN E Careful GYN ExamCareful GYN ExamOther pathology can be noted in geriatric Other pathology can be noted in geriatric

f l l tif l l tifemale populationfemale population

Anorectal examAnorectal examAnorectal examAnorectal exam

ExcoriationExcoriation Patulous anusPatulous anus Patulous anusPatulous anus Observe for mucosal/complete rectal Observe for mucosal/complete rectal

prolapseprolapseprolapseprolapseOften hard to demonstrate in officeOften hard to demonstrate in officeA k f i tA k f i tAsk for picturesAsk for picturesMay need bedside commodeMay need bedside commode

DREDREDREDRE

Decreased toneDecreased tone Squeeze toneSqueeze tone Squeeze toneSqueeze tone Possible bimanualPossible bimanual

R t lR t l RectoceleRectocele Impacted fecesImpacted feces

Report anatomically vs o’clockReport anatomically vs o’clock Report anatomically vs. o clockReport anatomically vs. o clock

Evaluation of Fecal IncontinenceEvaluation of Fecal IncontinenceEvaluation of Fecal IncontinenceEvaluation of Fecal Incontinence

History and clinical evaluationHistory and clinical evaluation

Physiological assessmentPhysiological assessmenty gy g Anorectal manometryAnorectal manometry Endoanal ultrasoundEndoanal ultrasound Defecography?Defecography?

Anorectal ManometryAnorectal ManometryAnorectal ManometryAnorectal Manometry

Radial catheter Radial catheter -- 1 cm intervals1 cm intervals

PressuresPressures Resting pressureResting pressure Resting pressureResting pressure Squeeze pressureSqueeze pressureSphincter lengthSphincter length Sphincter lengthSphincter length

SensibilitySensibility

Endoanal UltrasonographyEndoanal UltrasonographyEndoanal UltrasonographyEndoanal Ultrasonography

UltrasoundUltrasound -- Normal AnatomyNormal AnatomyUltrasound Ultrasound -- Normal AnatomyNormal Anatomy

Upper sphincterUpper sphincter

Mid sphincterMid sphincterMid sphincterMid sphincter

Di t l hi tDi t l hi tDistal sphincterDistal sphincter

Endoanal UltrasonographyEndoanal UltrasonographyEndoanal UltrasonographyEndoanal Ultrasonography

NormalNormal SphincterSphincter defectdefect

Pudendal LatencyPudendal LatencyPudendal LatencyPudendal Latency

•• Prolonged = nerve injuryProlonged = nerve injury

DefecographyDefecographyDefecographyDefecography

Contrast in rectum + vaginaContrast in rectum + vagina Rectal emptyingRectal emptying Rectal emptying Rectal emptying Sitting positionSitting position

Rectal ProlapseRectal ProlapseRectal ProlapseRectal Prolapse

Rectal IntussusceptionRectal IntussusceptionRectal IntussusceptionRectal Intussusception

DefecographyDefecography showing showing g p yg p y ggInternal Internal ProlapseProlapse

RectalRectal ProlapseProlapseRectal Rectal ProlapseProlapse

Mucosal Mucosal ProlapseProlapse True (FullTrue (Full--thickness)thickness) ProlapseProlapse True (FullTrue (Full thickness) thickness) ProlapseProlapse

MucosalMucosal ProlapseProlapseMucosalMucosal ProlapseProlapse

TrueTrue ProlapseProlapse

EndoscopyEndoscopyEndoscopyEndoscopy

Good opportunity to update Good opportunity to update appropriate health maintenanceappropriate health maintenancepp ppp pProctitisProctitisColitisColitisColitisColitisVillous adenomaVillous adenoma

ProlapseProlapse SurgerySurgeryProlapseProlapse SurgerySurgery MucosalMucosal ProlapseProlapse Mucosal Mucosal ProlapseProlapse

–– Surgical excision similar to Surgical excision similar to hemorrhoidectomyhemorrhoidectomy–– Good LongGood Long--term resultsterm results–– Good LongGood Long--term resultsterm results

True True ProlapseProlapse–– PerinealPerineal proctectomyproctectomyPerinealPerineal proctectomyproctectomy

Well toleratedWell tolerated Short hospital stayShort hospital stay

–– Abdominal approachAbdominal approach Better longBetter long--term resultsterm results More potential morbidityMore potential morbidityo e po e a o b d yo e po e a o b d y RectopexyRectopexy +/+/-- sigmoidectomysigmoidectomy depending on depending on

constipation symptomsconstipation symptoms

Treatment OptionsTreatment OptionsFecal IncontinenceFecal Incontinence

Diet / medicationDiet / medication BiofeedbackBiofeedbackBiofeedbackBiofeedback SphincteroplastySphincteroplasty

ColostomyColostomy ColostomyColostomy

New treatment modalitiesNew treatment modalities

ConservativeConservativeConservativeConservative

Diarrhea most common aggravating Diarrhea most common aggravating factor for incontinencefactor for incontinence

Aim for 1Aim for 1--2 well formed bm/day2 well formed bm/day Constipating agentsConstipating agents Constipating agentsConstipating agents Bulking agentsBulking agents Stop laxativesStop laxatives

BiofeedbackBiofeedbackBiofeedbackBiofeedback

Mild Mild -- moderate symptomsmoderate symptoms

BiofeedbackBiofeedbackResultsResults

NN CuredCured ImprovedImprovedppUrge incontinenceUrge incontinence 6060 55%55% 21%21%Passive incontinencePassive incontinence 2222 23%23% 36%36%Passive incontinencePassive incontinence 2222 23%23% 36%36%

Norton & Norton & KammKamm, BJS 1999, BJS 1999

SphincteroplastySphincteroplastySphincteroplastySphincteroplasty

SphincteroplastySphincteroplastyResultsResults

NN G dG d S b ti lS b ti lNN GoodGood SuboptimalSuboptimalFleshman 1994Fleshman 1994 5555 72%72% 28%28%Londono 1994Londono 1994 9494 50%50% 49%49%Londono 1994Londono 1994 9494 50%50% 49%49%Oliveira 1996Oliveira 1996 5555 70%70% 30%30%

Early Experience

Malouf 2000Malouf 2000 4747 34%34% 66%66%Halvorsen 2002Halvorsen 2002 4949 38%38% 62%62%

y p

Bravo Gutierrez 2004Bravo Gutierrez 2004 130130 41%41% 57%57%Later Experience

Injectable BiomaterialsInjectable BiomaterialsTechniqueTechnique

Submucosal injectionSubmucosal injection EasyEasy No local anestheticNo local anesthetic 11--4 sites (max 2ml at each site)4 sites (max 2ml at each site)

hh Intersphincteric injectionIntersphincteric injection Ultrasound directed?Ultrasound directed?

Local anestheticLocal anesthetic Local anestheticLocal anesthetic 11--4 sites4 sites

Preliminary ResultsPreliminary ResultsPreliminary ResultsPreliminary Results

Bioplastique (silicone based)Bioplastique (silicone based) Intersphincteric spaceIntersphincteric spaceIntersphincteric spaceIntersphincteric space Randomized +/Randomized +/-- ultrasound (42/ 40 pts)ultrasound (42/ 40 pts)

Ultrasound patients superior outcomeUltrasound patients superior outcome69% 40% h d 50% i t69% 40% h d 50% i t 69% vs. 40% had >50% improvement69% vs. 40% had >50% improvement

TjandraTjandra et al. DCR 2004et al. DCR 2004

Recent developmentsRecent developmentsRecent developmentsRecent developments

Approval of Approval of SolestaSolesta–– InjectableInjectable dextranomerdextranomer // HyaluronateHyaluronateInjectableInjectable dextranomerdextranomer / / HyaluronateHyaluronate–– SubmucosalSubmucosal anal canal injectionanal canal injection

Paucity of LongPaucity of Long--term Dataterm Data Paucity of LongPaucity of Long--term Dataterm Data–– 2 yr efficacy2 yr efficacy

3030 50% improvement in number of50% improvement in number of–– 3030--50% improvement in number of 50% improvement in number of incontinent episodesincontinent episodes

Reports of Adverse eventsReports of Adverse events Reports of Adverse eventsReports of Adverse events

Unresolved QuestionsUnresolved QuestionsInjectable Bulking AgentsInjectable Bulking Agents

EfficacyEfficacy Optimal locationOptimal locationOptimal locationOptimal location Optimal materialOptimal material

Durability and safetyDurability and safety Durability and safetyDurability and safety

Artificial Bowel SphincterArtificial Bowel SphincterArtificial Bowel SphincterArtificial Bowel Sphincter

End stage fecal incontinenceEnd stage fecal incontinence Intact anal sphincter not neededIntact anal sphincter not neededIntact anal sphincter not neededIntact anal sphincter not needed Success rate ~ 50Success rate ~ 50--70%70% InfectionInfection Infection Infection ErosionErosion

Few specializedFew specialized centerscenters Few specialized Few specialized centerscenters NOW UNAVAILABLENOW UNAVAILABLE

Typical ABS PatientTypical ABS PatientWater Skiing AccidentWater Skiing Accident

Manometric pressures minimalManometric pressures minimal Nerve function intactNerve function intact

Infection RatesInfection RatesArtificial Bowel SphincterArtificial Bowel Sphincter

NN Infection rateInfection rateWong (2002)Wong (2002) 112112 31%31%Wong (2002)Wong (2002) 112112 31%31%Parker (2002)Parker (2002) 4545 34%34%Michot (2003)Michot (2003) 2525 12%12%Michot (2003)Michot (2003) 2525 12%12%Devesa (2002)Devesa (2002) 5353 18%18%Oritz (2002)Oritz (2002) 2222 9%9%

ABSABS -- IncisionsIncisionsABS ABS -- IncisionsIncisions

S l N Sti l tiS l N Sti l tiSacral Nerve StimulationSacral Nerve Stimulation

SNS delivers SNS delivers mild electrical pulses to mild electrical pulses to the sacral nerves. This action the sacral nerves. This action modulates modulates effectoreffector organs which the organs which the sacral nerves innervate: bladder, sacral nerves innervate: bladder,

i d l hi t l ii d l hi t l iurinary and anal sphincters, pelvic urinary and anal sphincters, pelvic floor, and colon.floor, and colon.

SNSSNS TherapyTherapySNS SNS TherapyTherapy11 Tined leadTined lead is placedis placed1.1. Tined leadTined lead is placed is placed

parallel to the sacral parallel to the sacral (S2, S3, or S4) nerve.(S2, S3, or S4) nerve.

22 ImplantableImplantable

3

2.2. Implantable Implantable neurostimulatorneurostimulatorgenerates mild electrical generates mild electrical pulses that are delivered pulses that are delivered through the lead through the lead electrodes.electrodes.

3.3. Clinician and patient Clinician and patient 2 ppprogrammersprogrammers are used are used to set the parameters to set the parameters of the electrical pulses.of the electrical pulses.

1

History of History of SNS SNS ––20+ years treating the pelvic20+ years treating the pelvic20+ years treating the pelvic 20+ years treating the pelvic

floorfloor1981 1981 Department of Urology, University of California at Department of Urology, University of California at

San Francisco initiated clinical programSan Francisco initiated clinical program

19851985--92 92 MultiMulti--center trialcenter trial

1994 1994 CE mark for CE mark for InterStimInterStim Therapy for treatment of:Therapy for treatment of:Pelvic Floor DisordersPelvic Floor Disorders(Urinary and fecal (Urinary and fecal incontinenceincontinence))

19971997 FDA approval of FDA approval of InterStimInterStim Therapy for treatment of: Therapy for treatment of: Urge incontinenceUrge incontinence

1999 1999 FDA approval of FDA approval of InterStimInterStim Therapy for treatment of:Therapy for treatment of:UrgencyUrgency--frequency frequency Urinary retentionUrinary retention

ff SS f ff f20112011 FDA approval of FDA approval of InterStimInterStim Therapy for treatment of:Therapy for treatment of:Chronic fecal incontinenceChronic fecal incontinence

Th i f th d f tiTh i f th d f tiTheories of method of action Theories of method of action NeuromodulationNeuromodulation may affect the premay affect the pre existing activity in sensory fiberexisting activity in sensory fiberNeuromodulationNeuromodulation may affect the premay affect the pre--existing activity in sensory fiberexisting activity in sensory fiberpathways that control:pathways that control:

M l f tiM l f ti–– Muscular functionMuscular function

–– Misplaced sensory signalsMisplaced sensory signalsMisplaced sensory signalsMisplaced sensory signals

–– Increased sensory inputIncreased sensory input

–– Dysfunctional neural Dysfunctional neural reflexesreflexes

–– NOT an ON/OFF switch for the sphincterNOT an ON/OFF switch for the sphincter

SNS / SNS / InterStimInterStim Therapy Therapy pypyindicationsindications

Chronic fecal incontinenceInterStim Therapy for bowel control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservativehave failed or are not candidates for more conservative treatments.

InterStim Therapy for InterStim Therapy for pypyBowel ControlBowel Control

Patient Selection:Patient Selection:Patients should be carefully selected to ensure thatPatients should be carefully selected to ensure thatthey meet the following criteria:they meet the following criteria:

–– They are appropriate candidates for surgery.They are appropriate candidates for surgery.–– They can properly operate the system.They can properly operate the system.y p p y p yy p p y p y–– They received satisfactory results from test stimulation. They received satisfactory results from test stimulation.

Contraindication:Contraindication:Contraindication:Contraindication:This therapy is contraindicated for patients who willThis therapy is contraindicated for patients who willbe exposed to diathermy (deep heat treatment). be exposed to diathermy (deep heat treatment).

InterStim Therapy test InterStim Therapy test stimulationstimulationstimulationstimulationPragmatic patient selectionPragmatic patient selectiong pg p

Minimally invasive test to gauge:Minimally invasive test to gauge: Response of symptoms to stimulationResponse of symptoms to stimulation Candidates for full implantCandidates for full implant

Test results, patients with:Test results, patients with: ≥≥ 50% reduction in symptoms are good 50% reduction in symptoms are good

candidates for full implantcandidates for full implant50% d i i h 250% d i i h 2 dd < 50% reduction in symptoms may have a 2< 50% reduction in symptoms may have a 2ndnd testtest

Clinical studies of Clinical studies of InterStim TherapyInterStim Therapy

Safety and efficacy ofSafety and efficacy of InterStimInterStim TherapyTherapySafety and efficacy of Safety and efficacy of InterStimInterStim Therapy Therapy have been demonstrated in multiple have been demonstrated in multiple single and multicenter trials.single and multicenter trials.

The studies vary in design and number The studies vary in design and number of patientsof patientsof patients. of patients.

There is general agreement thatThere is general agreement thatThere is general agreement that There is general agreement that InterStimInterStim Therapy greatly improves Therapy greatly improves continence and quality of life.continence and quality of life.11

1. Matzel KE. Acta Neurochir Suppl. 2007;97(Pt 1):351-7.

Four studies, different Four studies, different ,,designs, similar resultsdesigns, similar results

1.1. InterStimInterStim Therapy for Bowel Control ProspectiveTherapy for Bowel Control Prospective1.1. InterStimInterStim Therapy for Bowel Control Prospective Therapy for Bowel Control Prospective Clinical StudyClinical Study ―― a prospective, nona prospective, non--randomized, randomized, multimulti--center study. (center study. (nn = 120) = 120) 1, 21, 2

2.2. TjandraTjandra StudyStudy ―― a prospective, randomized, a prospective, randomized, singlesingle--center study. (center study. (nn = 113) = 113) 33

3.3. LeroiLeroi StudyStudy ―― a prospective, randomized, a prospective, randomized, double arm, blinded, singledouble arm, blinded, single--center study. (center study. (nn = 27) = 27) 44

4.4. HetzerHetzer StudyStudy ―― a prospective, nona prospective, non--randomized, randomized, singlesingle--center study. (center study. (nn = 30) = 30) 55

1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2010 3. Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502.4. Leroi AM, Parc Y, et al. Ann Surg. 2005 Nov;242(5):662-9.5. Hetzer FH, Hahnloser D, et al. Arch Surg. 2007 Jan;142(1):8-13.

Common Common endpoint:endpoint:≥ 50% reduction in weekly incontinent ≥ 50% reduction in weekly incontinent episodesepisodes

Patients who achieved Patients who achieved endpoint endpoint at 12 monthsat 12 months

InterStimInterStim Therapy for Bowel Control ProspectiveTherapy for Bowel Control ProspectiveClinical Study Clinical Study 1, 21, 2

83% per83% per protocol 73% MWCprotocol 73% MWC83% per83% per--protocol, 73% MWCprotocol, 73% MWCpp < 0.0001< 0.0001

TjandraTjandra Study Study 3370.8%, 70.8%, pp < 0.0001< 0.00011. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9.

2 Medtronic sponsored research InterStim Therapy Clinical Summary Insert 20102. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 20103. Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502.

C l t C tiC l t C tiComplete ContinenceComplete ContinenceInterStim Therapy Bowel Control Study

40

50

nts

30

40

of P

atie

n 41%36%

10

20

Per

cent

Per protocolMWC

0

Per-protocol (n=106)

MWC(n=120)

12 months compared to baseline1. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 2. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2010.

TjandraTjandra et al. Study et al. Study ――Reduction in Weekly Incontinent EpisodesReduction in Weekly Incontinent Episodes

SNS G i t i

ekly

SNS Group improvement is clinically relevant and statistically significant(p < 0.0001)

9.49.2 9.5m

ber o

f Wee

ent E

piso

des

Mea

n nu

Inco

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SNS Group ( 53)

Control Group ( 60)

3.1

(n=53)(n=60)

12 Mo

Basel

12 Mo

Basel

Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502.

nths

ine

nths

ine

Maximum degree of externalMaximum degree of externalMaximum degree of external Maximum degree of external sphincter defectsphincter defect

LeroiLeroi StudyStudy11

≤≤ 3030°°InterStimInterStim Therapy for Bowel Control ProspectiveTherapy for Bowel Control ProspectiveInterStimInterStim Therapy for Bowel Control ProspectiveTherapy for Bowel Control ProspectiveClinical StudyClinical Study2, 32, 3

≤≤ 6060°° 60°90°120° 30°≤≤ 6060

HetzerHetzer StudyStudy44

≤≤ 9090°°

30

≤≤ 9090°°

TjandraTjandra StudyStudy551. Leroi AM, Parc Y, et al. Ann Surg. 2005 Nov;242(5):662-9.2. Wexner SD, Coller JA, et al. Ann Surg. 2010 Mar;251(3):441-9. 3. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2010

≤≤ 120120°° 4. Hetzer FH, Hahnloser D, et al. Arch Surg. 2007 Jan;142(1):8-13.5. Tjandra JJ, Chan MK, et al. Dis Colon Rectum. 2008 May;51(5):494-502.

InterStimInterStim Therapy for Bowel Therapy for Bowel C t l P ti Cli i lC t l P ti Cli i lControl Prospective Clinical Control Prospective Clinical Study Study ―― Safety ResultsSafety Resultsyy yy

The most common adverse events (≥5%)The most common adverse events (≥5%)reported during the implant phase:reported during the implant phase:11gg

–– Implant site pain Implant site pain == 25.8%25.8%

–– Paresthesia Paresthesia == 12.5%12.5%

–– Implant site infection Implant site infection == 10.8%10.8%

–– Change in sensation of stimulationChange in sensation of stimulation == 8 3%8 3%Change in sensation of stimulation Change in sensation of stimulation 8.3%8.3%

–– Urinary incontinence Urinary incontinence == 6.7%6.7%

DiarrheaDiarrhea == 5 0%5 0%–– Diarrhea Diarrhea == 5.0%5.0%

Mitigation of adverse Mitigation of adverse ggeventsevents

Many of the adverse events were Many of the adverse events were successfully treated with medication orsuccessfully treated with medication orsuccessfully treated with medication, or successfully treated with medication, or reprogramming of the device.reprogramming of the device.

QOL: FI patients vs QOL: FI patients vs pppatients w/o FIpatients w/o FI

Rockwood TH, Church JM, Fleshman JW, et al. Dis Colon Rectum. 2000 Jan;43(1):9-16.

FIQOL FIQOL ― ― Improvement in Improvement in Quality of LifeQuality of Life

InterStim Therapy for Bowel Control

Phases of InterStim TherapyPhases of InterStim Therapy

Test stimulation periodTest stimulation period–– Up to 7 days (PNE)Up to 7 days (PNE)–– Up to 14 days (tined lead)Up to 14 days (tined lead)

LongLong--term therapyterm therapy–– Implantation of neurostimulator (INS)Implantation of neurostimulator (INS)

Benefits of Test Stimulation Period Verifies neural integrityVerifies neural integrity

Benefits of Test Stimulation Period

Allows the patient to feel stimulationAllows the patient to feel stimulation

Provides an opportunity to assess the viability of InterStim Provides an opportunity to assess the viability of InterStim ThThTherapyTherapy

Helps the physician and patient make an informed choice Helps the physician and patient make an informed choice about the longabout the long--term therapeutic value of InterStim Therapyterm therapeutic value of InterStim Therapy

Symptom

about the longabout the long term therapeutic value of InterStim Therapyterm therapeutic value of InterStim Therapy

SymptomControl

Identify Landmarks Under FluoroscopyIdentify Landmarks Under FluoroscopyOne electrode on the lead:

Identify Landmarks Under FluoroscopyIdentify Landmarks Under Fluoroscopy

One electrode on the lead

Identify Landmarks Under FluoroscopyIdentify Landmarks Under FluoroscopyIdentify Landmarks Under FluoroscopyIdentify Landmarks Under FluoroscopyOne electrode on the lead:

Test Stimulation: Place the test leadTest Stimulation: Place the test lead

Look for Motor and Sensory RResponses

Connect the Lead to External Test Connect the Lead to External Test StimulatorStimulator

When desired responses are achieved, the lead is secured and connected to an external test stimulator

If Test Stimulation Successful, If Test Stimulation Successful, Implant SystemImplant SystemImplant SystemImplant System• Implanted lead and InterStim implantable neurostimulator (INS)

are placed in the OR• Lead location (S3) is critical to the success of therapy

3210

TreatmentTreatment SummarySummary -- FIFITreatment Treatment Summary Summary -- FIFI Non surgicalNon surgical treatment always firsttreatment always firstNon surgical Non surgical treatment always firsttreatment always first

Dietary ModificationDietary Modification AntiAnti--diarrheal medicationsdiarrheal medications BiofeedbackBiofeedback

ProlapseProlapse –– Surgical OptionsSurgical Options SphincteroplastySphincteroplasty for localized for localized injuriesinjuries

Must be localized temporallyMust be localized temporallyRare in elderlyRare in elderly Rare in elderlyRare in elderly

Poor longPoor long--term resultsterm results New treatmentNew treatment modalitiesmodalities New treatment New treatment modalitiesmodalities

InjectableInjectable MaterialsMaterials SNSSNS

ConclusionsConclusionsConclusionsConclusions

Incontinence is a common Incontinence is a common problemproblem–– Profound social and economic impactProfound social and economic impact

H + P H + P importantimportant Objective evaluation can help guide Objective evaluation can help guide Object e e a uat o ca e p gu deObject e e a uat o ca e p gu de

treatmenttreatment Treatments continue to Treatments continue to evolveevolveea e s co ue oea e s co ue o e o ee o e SNS is a promising new modalitySNS is a promising new modality