New Surgical Advances in the Treatment of Fecal Incontinence Steven D Wexner, M.D., FACS, FRCS, FRCS (Ed) Chairman, Department of Colorectal Surgery Cleveland Clinic Florida 21st Century Chair in Colorectal Surgery Professor of Surgery, Ohio State University Health Sciences Center at the Cleveland Clinic Foundation Clinical Professor of Surgery, University of South Florida College of Medicine Dept of Biomedical Science Florida Atlantic University College of Medicine

> Injectable silicone > Injectable submucosal beads (ACYST TM ) > Radiofrequency (SECCA TM ) > Artificial Bowel Sphincter > Unstimulated Bilateral Gluteoplasty > Stimulated Graciloplasty > Sacral Nerve Stimulation New Surgical Treatments for Fecal Incontinence New Surgical Treatments for Fecal Incontinence

OVERLAPPING SPHINCTER REPAIR: SHORT TERM AuthorYearnObstetric/Results Operative trauma Excellent Fair Poor Fleshman Wexner Fleshman Engel Engel Simmang

OVERLAPPING SPHINCTER REPAIR: SHORT TERM AuthorYearnObstetric/Results (%) Operative trauma Excellent Poor Londono Oliveira Felt-Bersma Nikiteas Sitzler Ternent Barisic

OVERLAPPING SPHINCTER REPAIR: LONG TERM > 49 patients > 6 year follow–up after sphincteroplasty > Telephone interviews using Fecal Incontinence Quality of Life Scale and Fecal Incontinence Severity Index –46% continence –14% complete continence Halverson, DCR 2002

OVERLAPPING SPHINCTER REPAIR: LONG TERM > 191 patients > 10 year follow-up with questionnaire to assess current bowel function and quality of life > Continence rates –40% at 10 years –6% complete continence at 10 years > Predictors of incontinence at 10 years –Older patients –Those with incontinence in short term Gutierrez, DCR, 2004

OVERLAPPING SPHINCTER REPAIR: SHORT & LONG TERM > 65 patients > CCF/FI score and Browning-Parks scale calculated preop, 3 month and 80 month postop Barisic, Int J Colorectal Dis, 2006

OVERLAPPING SPHINCTER REPAIR: SHORT & LONG TERM > 3 month: % excellent % excellent % good % good % fair % fair - 9.2% poor - 9.2% poor Barisic, Int J Colorectal Dis, 2006 > 80 month: % excellent % excellent % good % good % fair % fair % poor % poor > CCF/FI score: - Improved from 17.8 preop to 3.6 three month postop - Improved from 17.8 preop to 3.6 three month postop - Deteriorated to 6.3 after 80 months (p<0.001) - Deteriorated to 6.3 after 80 months (p<0.001)

Pudendal Neuropathy AuthorNSuccess Successp Value withoutwith NeuropathyNeuropathy Laurberg, %11%<0.05 Simmans, %67%--- Londono, %30%<0.001 Stitzler, %63%--- Sangwan, %14%<0.005 Gilliland, %17%<0.01

OVERLAPPING SPHINCTEROPLASTY Why do we preserve the scar? Female patients with fecal incontinence who underwent overlapping anterior sphincter repair between June 1998 and May 1999 were preoperatively evaluated with: > Anal manometry > Electromyography and pudendal nerve terminal motor latency > Endosonography

OVERLAPPING SPHINCTEROPLASTY Why do we preserve the scar? > Continence was assessed by standardized scoring from 0 to 20 both before and after surgery > The intraoperative ultrasound was performed at the end of the operation with a intrarectal transducer

Overlapping Sphincteroplasty Why do we preserve the scar?  Preoperative  Preoperative Postoperative Postoperative Incontinence score Patients Incontinence score pre and post operative in muscle-muscle or muscle-scar (type 1-2 overlapping)

Overlapping Sphincteroplasty Why do we preserve the scar?  Preoperative  Preoperative Postoperative Postoperative Incontinence score Patients Incontinence score pre and post operative overlapping scar-scar

POSTANAL REPAIR Results (%) Results (%) InstitutionYear NumberExcellent/FairPoor patientsGood Keighley Henry Browning Ferguson

POSTANAL REPAIR Results (%) InstitutionYear NumberExcellent/FairPoor patientsGood Vroonhaven Womack Scheuer Orrom

POSTANAL REPAIR > 21 patients (67 (40-80) years of age) > 6.8 (0.5-22) years incontinence > 10 prior sphincteroplasties > 5% morbidity, 0% mortality at months > 35% success –Preoperative incontinence score –Postoperative incontinence score Matsuoka, DCR 2000

INJECTION OF AUTOLOGOUS FAT > 14 patients (9 F, 5 M; age range years) > Causes of incontinence –Idiopathic6 –Hemorrhoidectomy3 –Internal sphincterotomy4 –Perianal tear1 > Operative procedure –Fat harvesting (50ml), 3-5cm below umbilicus –Fat “washing” with saline –Injection submucosally into the rectal neck at the 3 o’clock and 9 o’clock position (Shafik, DCR 1997)

INJECTION OF AUTOLOGOUS FAT > Follow up –9-24 months > Results –3 patients continent –9 patients continent after a second injection (6 months later) –2 patients partially continent after multiple injections (Shafik, DCR 1997)

INJECTION OF AUTOLOGOUS FAT 34 year old female > Failure of previous anterior sphincteroplasty > Operative technique –Liposuction from the buttock –Fat injection (70ml) beneath anal mucosa in correspondence with sphincter defect > Results –No postoperative complications –Reinjection of 60ml of fat 4 months later –Fully continent 8 months after 2nd injection (Bernardi, Plastic and Reconstruct Surg 1998)

INJECTABLE SILICONE SHORT AND MEDIUM TERM RESULTS > Internal anal sphincter augmentation using injectable silicone > 10 patients (6 females) > 64 (41-80) years old > Weak (6) or disrupted (4) internal sphincter > Injection – single site (4) or circumferential (6) Malouf et al. DCR 2001

> 6 weeks –Complete resolution: 3 –Improved: 3 –1 improved after 2 nd injection –70% success > 6 months –Improved: 2 –Minor improvement: 1 –30% success INJECTABLE SILICONE SHORT AND MEDIUM TERM RESULTS Malouf et al. DCR 2001

INJECTABLE SILICONE MEDIUM TERM RESULTS > 82 patients > Internal anal sphincter dysfunction > 2 groups: Injection of the Bioplastique in the intersphincteric space –With guidance of ultrasound (n = 42) –Without guidance of ultrasound (n= 40) > No complications > At 1 month, ultrasound confirmed retention of the silicone in all patients Tjandra, DCR 2004

> Significant improvement: –In all, at one month –In all, at 6 months –In group A only, at 12 months (p<0.001) > At 6 months, all domains of FI QOL scale improved significantly in both groups > Prolonged pudendal nerve terminal motor latency had no effect on outcome in either group. INJECTABLE SILICONE MEDIUM TERM RESULTS Tjandra, DCR 2004

ACYST TM or DURASPHERE FI™ 1cc Syringe Carbon Beads

ACYST™ or DURASPHERE FI™ > Microscopic picture of pyrolitic carbon beads > Each carbon bead is µm > Suspension of carbon bead in a gel consisting of water and beta-D glucan.

ACYST™ or DURASPHERE FI™ -Outpatient, open-label trial -10 patients followed for 12 months -Ambulatory injection of ACYST TM carbon coated beads -No changes in the results of anorectal physiology testing during 12 months -1 complication consisting of extravasation of beads causing pain

Conclusions - ACYST ™ or DURASPHERE FI™ > 80% of patients improve following ACYST™ injections > 23% improvement in incontinence scores from a mean of 13 preprocedure to 10 at 3mos > 30% improvement in incontinence scores at 6mos(6pts) ICS 9.3 > Improvement in FIQL scores in all 4 scales at 3 months

Conclusions: Injectable Silicone and ACYST > Simple > Office Based > Ambulatory > Moderate to severe incontinence > Good short term outcome > Minimal complications

Radiofrequency (SECCA TM ) Temperature-controlled radiofrequency delivery

Temperature Ramp-up during RF delivery

Radiofrequency

> CCF FI score improved from 13.8 to 7.3 (p CCF FI score improved from 13.8 to 7.3 (p<0.002) > All FIQOL parameters improved (p All FIQOL parameters improved (p<0.01) - Lifestyle- Coping - Depression- Embarrassment > Social function SF 36 improved (p=0.04) > Use of pads eliminated in 4 of 7 patients > No significant changes between 12 and 24 months > No long term complications Radiofrequency: 2 year-results Radiofrequency: 2 year-results Takahashi et al, DCR, 2003

> 5 centers, open label, prospective trial > 43 Females, 7 males > Mean age: 61.1 (30-80) years > Mean length of fecal incontinence: 14.9 years > 11 (22%) patients had previous surgery for fecal incontinence –9.18% Sphincter repair –2.4% Artificial bowel sphincter > 6 months follow-up > Mean treatment time: minutes Efron et al, DCR 2003 Radiofrequency: 6 month follow-up

Efron et al, DCR 2003 Radiofrequency Fecal Incontinence 6 months BeforeAfter CCF Incontinence Score (0-20) ; p <0.0001

Efron et al, DCR 2003 Radiofrequency Fecal Incontinence Quality of Life 6 months Lifestyle FIQOL (1 – 4/4.4) ; p < CopingDepressionEmbarrassment

Efron et al, DCR 2003 Radiofrequency SF 36 Quality of Life 6 months Before After p <0.003 Social FunctionMental Health BeforeAfter p <0.02

Results: Complications Adverse Eventn% Mucosal Ulcerations24 % Bleeding Requiring Intervention 12 % Minor Bleeding510 % Antibiotic Induced Diarrhea714 % Fever24 % Vomiting12 % Constipation12 % Groin swelling12 % Hot flashes12 % Efron et al, DCR 2003

Results: Anorectal Manometry p= p=0.05 Efron et al, DCR 2003

Results Effect on Anorectal Physiology Anal manometry > Significant reduction in both threshold and maximal rectal volumes > No changes in anal resting or squeeze pressures Endoanal Ultrasound > No change Pudendal Nerve Terminal Motor Latency > No change Efron et al, DCR 2003

Radiofrequency 1 year results > 10 female patients –FI for at least 3 months, 1x/week –Failed biofeedback and conservative Rx > Age: 55.9 (range 44-74) years > Sedation and local anesthesia > Procedure time: 65.4 minutes > RF energy delivery time: 27.7 minutes Takahashi et al, DCR, 2002

Radiofrequency: 1 year results > Complications –Bleeding (3 spontaneous resolution, 1 suture ligation) > 6 months FU –Anoscopy: normal –Manometry:  in initial and max tolerable volumes –EAUS: no new defects or scar tissue Takahashi et al, DCR, 2002

Radiofrequency: 1 year follow-up > One year follow-up > CCF Incontinence score improved (13.5 to 5; p CCF Incontinence score improved (13.5 to 5; p<0.001) > All FIQOL parameters improved (p All FIQOL parameters improved (p<0.05) - Life style- Coping - Life style- Coping - Depression - Embarrassment - Depression - Embarrassment > Use of pads eliminated in 5 of 7 patients Takahashi et al, DCR, 2002

> 10 females > CCF FI score improved from 13.8 to 7.3 (p CCF FI score improved from 13.8 to 7.3 (p<0.002) > All FIQOL parameters improved (p All FIQOL parameters improved (p<0.01) - Lifestyle- Coping - Depression- Embarrassment > Social function SF 36 improved (p=0.04) > Use of pads eliminated in 4 of 7 patients > No significant changes between 12 and 24 months > No long term complications Radiofrequency: Radiofrequency: 2 year-results Takahashi et al, DCR, 2003

Results: 2 year follow-up Cleveland Clinic Florida-Incontinence Score *p<0.05 versus baseline

Fecal Incontinence Quality of Life Results: 2 year follow-up All p<0.01

SF-36 General Quality of Life Results: 2 year follow-up p=0.004 p=0.11

Radiofrequency > Currently, prospective, randomized, sham- controlled trial is underway > Safe, effective, minimally invasive

Artificial Bowel Sphincter (ABS) Cuff Ballon Pump FDA approved in 1999

ABS: Safety and efficacy ABS: Safety and efficacy > Multicenter, prospective, non-randomized > 112 patients were implanted > Mean age 49 (range 18-81) years > 384 device related adverse events in 99 patients > 246 required either no or non-invasive intervention > 73 revisional operations in 51(46%) patients > Infection requiring surgical revision was 25% > 41(37%) patients had devices completely explanted –7 had successful reimplantations Wong et al, DCR, 2002 Wong et al, DCR, 2002

> Functioning sphincter: improved QOL and anal continence > FI (scale, 1-120) scores improved from 105 to 51 (63 patients at 6 months) from 105 to 51 (63 patients at 6 months) from 105 to 48 (55 patients at 12 months) from 105 to 48 (55 patients at 12 months) > Successful outcome in 85% with functioning device > Intention to treat success rate of 53% > Conclusion: > High morbidity and need for revisional surgery > Improve FI and QOL in patients with severe FI Wong et al, DCR, 2002 ABS: Safety and efficacy ABS: Safety and efficacy

ABS: Long –Term Results Group I: 1989 – 1986 > n=10 > Mean age 35 (15-52 years; 3 females) > 6 Functioning > 4 Explanted Group II: > n=35 > Mean age: 47 (18-72 years; 25 females) > 17 (49%) Functioning Parker et al, DCR patients 45 patients

> 14/35 explanted –12 (34%) infection –2 (6%) pain > 21 revisions (7 complete replacement) > 19% infection after revision > 4 explanted after revision > 18 total failures (9 stomas) ABS: Long-Term Results ABS: Long-Term Results Parker et al, DCR 2003

> Improved quality of life scales –6 months and 1 year (p<0.01) > Improved fecal incontinence –Severity scores (p<0.001) > Success not improved with time > Infection remains major challenge > Once implanted remains stable ABS: Long-Term Results ABS: Long-Term Results Parker et al, DCR 2003

ABS: Other series Author/yr n F-U Morbidity Device Success (mos) (%) expl/impl (n) (%) Wong, Lehur, /2 67 Vaizey, /0 83 Christiansen, /0 47 O’Brien, /0 69 Lehur, /3 75 Altomare, /2 66 Devesa, Michot, / Casal, /2 90

Unstimulated Bilateral Gluteoplasty

Unstimulated Bilateral Gluteoplasty: Early Results Patients Good Results Fair Results Poor Results Chetwood Shoemaker Bistrom Bruining Prochiantz Hertz Skef Devesa and Fernandez, Semin in CRS 1997

Unstimulated Bilateral Gluteoplasty: Recent Results Patients Good Results Fair Results Poor Results Iwai Chen Onishi Pearl Christian sen Devesa 1992, TOTAL71 42 (59%) 9 (13%) 20(28%) Devesa and Fernandez, Semin in CRS 1997

Dynamic graciloplasty Dynamic graciloplasty

Dynamic Graciloplasty: safety and efficacy > Prospective multicenter trial > 20 institutions > 123 patients > 14 day diaries > 189 adverse events in 91 patients (74%) > 49 patients required 1 or more operations (40%) > 170 (90%) events were resolved Baeten et al, DCR, 2000

> Success: 50% or > decrease in incontinent events > No pre-existing stoma 63% at 12 months Additional 11% lesser degree of improvement > Pre-existing stomas 33% at 12 months 60% at 18 months Conclusion: > Objective improvement in majority of patients > Adverse events are frequently encountered, but most resolve with treatment Baeten et al, DCR, 2000 Dynamic Graciloplasty: safety and efficacy

> 129 patients –Europe: 67 –USA 45 –Canada:17 > 20 investigative sites > 27 pre-existing stoma > 88 no stoma at enrollment Wexner et al, DCR, 2002 Dynamic Graciloplasty: Long term efficacy

> Success: >50% decrease in FI episodes In non-stoma patients In stoma patients 62% - 12 months37.5% -12 months 55% - 18 months62% -18 months 56% - 24 months43% -24 months QOL: SF 36, significant improvement Conclusion: > Dynamic graciloplasty successful in majority of patients with end stage FI > Persisted at 2 years follow up Wexner et al, DCR, 2002 Dynamic Graciloplasty: Long term efficacy

> 200 consecutive patients (153 females) > 48 (15-77) years > 261 weeks median follow-up > 72% overall success > 16% disordered evacuation > 405 weeks median battery life Rongen et al, DCR 2003 Dynamic Graciloplasty: 2 Year Follow-up

Cause Patients (n) Success (%) Congenital2852 Trauma9882 Idiopathic5872 Neurologic1680 Total20072 Rongen et al, DCR 2003 Dynamic Graciloplasty: 2 Year Follow-up

Author, year n Follow-up (months) Morbidity (%) Revisional surgery (%) Success (%) Christiansen, Sielezneff, Mavrantonis, IM 6 DS Mander, Madoff, Konsten, IM 81 DS Bresler, Wexner, Rongen, Penninckx, Dynamic Graciloplasty: Other series IM – Intramuscular, DS – Direct stimulation

Electrically stimulated gracilis neoanal sphincter Author Method (n) Type of Follow-upSuccess Stimulation (months)(%) Altomare, incontinence (9) Direct nerve NR44 4 after APR Christiansen,1998  -monolateral(13)Intramuscular 1784 Sielezneff, 1999  -monolateral(16)Intramuscular 2081 Baeten, 1999 *  -monolateral(109)Intramuscular 1280 Mavrantonis, 1999  -monolateral(27) Intramuscular Direct nerve10 Mander, 1999 *  -monolateral(64)Intramuscular, 1056 Direct nerve Madoff, 1999 *  -monolateral(128)Intramuscular (*Multicenter trials) Mavrantonis, DCR 1999

Sacral Nerve Stimulation (SNS)

SACRAL NERVE STIMULATION SINGLE CENTER SERIES > 15 patients: temporary then permanent SNS > Median age 60 (range 37-71) years > Median FU: 24 (3-60) months > 11 fully continent >  episodes of FI after stimulation (median, 11-0, p  episodes of FI after stimulation (median, 11-0, p<0.001) Kenefick et al, Br J Surg, 2002

SACRAL NERVE STIMULATION SINGLE CENTER SERIES > Urgency improved in all patients (median,1-8, p=0.01) > Improvement in mean resting pressure (p Improvement in mean resting pressure (p<0.05) > Mean squeeze pressure increment 43 vs 69 (p Mean squeeze pressure increment 43 vs 69 (p<0.01) > SF 36: significant improvement > No major complications > Conclusion: > Safe,effective, minimal morbidity,benefit maintained medium term Kenefick et al, Br J Surg, 2002

SACRAL NERVE STIMULATION DOUBLE BLINDED CROSS-OVER TRIAL > 2 women (65 and 61) > Both received permanent stimulator > Each was turned on for 2 weeks and off for 2 weeks, and visa versa > Patients and investigators were blinded > Statistically significant decrease in number of incontinent episodes when the stimulator was on Vaizey, DCR 2000

SACRAL NERVE STIMULATION LARGEST SINGLE CENTER SERIES > Patients - 75 > Mean age - 52 > Median duration of FI – 5 years (1-66) > Temporary electrodes –not placed in 2 patients –Improved continence in 62% > After placement of permanent electrodes – improvement sustained > At 1 year, success rate of 76% for improved continence Uludag, DCR 2004

SACRAL NERVE STIMULATION MULTICENTER > 37 patients, permanent stimulator in 34 > Followed 24 months > Improved: –Incontinent episodes per week (p<0.0001) –Staining (p<0.0001) –Pad use (p<0.0001) –Ability to postpone defecation (p<0.0001) –Ability to completely empty the bowel (p<0.0001) > Quality of life improved –4/4 ASCRS scales (p<0.0001) –7/8 SF-36 scales though only social functioning was significantly improved (P=0.0002) Matzel, Lancet 2004

SACRAL NERVE STIMULATION REVIEW > 14 studies reviewed (188 patients) in whom permanent stimulators placed > Numerous indications: –Previous anorectal surgery –Cauda equina syndrome –Scleroderma –Idiopathic –Obstetric trauma –Trauma –Spinal cord lesion –Meningomyelocele –Multpile sclerosis Matzel, DCR 2004

> Most patients experienced improvement by 75% > Effects were consistent up to 99 months > Improvements in: –Incontinence –Ability to postpone defecation –Ability to empty rectum > Complication rate 0-50% –Pain at site of generator, electrode dislodgement, infection, loss of effect, deterioration of function SACRAL NERVE STIMULATION REVIEW Matzel, DCR 2004

> > Double-blind Multicenter > > 34 patients (31 women) > > 57 (33-73) years old > > 27/34 “on” or “off” x 1 month periods SACRAL NERVE STIMULATION CROSSOVER STUDY Leroi et al Ann Surg 2005

SACRAL NERVE STIMULATION CROSSOVER STUDY Characteristic Study Group (n = 34) Duration of incontinence <1 yr <1 yr 1–5 yr 1–5 yr 5–10 yr 5–10 yr >10 yr >10 yr12 12 (2) 4 (2) 4 (2) 6 (1) 6 (1) Type of incontinence Urge (inability to defer defecation) Urge (inability to defer defecation) Passive (no awareness of loss of stool) Passive (no awareness of loss of stool) Mixed Mixed 22 (2) 4 (2) 8 (1) Leroi et al Ann Surg 2005

SACRAL NERVE STIMULATION CROSSOVER STUDY Characteristic Study Group (n = 34) Main cause of incontinence Idiopathic Idiopathic Pudendal neuropathy Pudendal neuropathy Postoperative IAS fragmentation Postoperative IAS fragmentation Primary IAS degeneration Primary IAS degeneration 18 (3) 14 (2) 11 Previous surgical procedures Sphincter repair Sphincter repair Prolapse repair Prolapse repair Pelvic floor repair Pelvic floor repair 3 (2) 21 Ultrasound findings IAS defect IAS defect EAS defect EAS defect 7 (2) 7 (1) Leroi et al Ann Surg 2005

SACRAL NERVE STIMULATION CROSSOVER STUDY Leroi et al Ann Surg 2005

SACRAL NERVE STIMULATION CROSSOVER STUDY Variable On vs Off (P Value) Greater Improvement 0.02 Patient Preference 0.02 Frequency of Incontinence Ability to Postpone Evacuation 0.01 CCF/Wexner Incontinence Score Quality of Life < 0.05 Anal Sphincter Function Maximum Resting Maximum Resting0.02 Leroi et al Ann Surg 2005

Author, yearnFollow-up (months) ScoreImprovement Malouf, Wexner 16 -> 2 Ganio, Williams 4.1 -> 1.25 Matzel, Wexner 17-> 2 Rosen, FI episodes 6 -> 2 Leroi, 01 66Urgency 4.8 -> 2.3 Ripetti, Wexner > 9.8 Kenefick, FI episodes 11-> 0 Uludag, FI episodes 7.5-> 0.67 Matzel, FI episodes 16.4->2.0 Jarrett, Williams 7.5 -> 1 Rasmussen, Wexner 16 ->6 SNS: Permanent implant results

SACRAL NERVE STIMULATION REVIEW – QUALITY OF LIFE SF-36FIQOL Categories Improved LifestyleCoping/Behavior Depression/ Self- perception Embar- rassment Malouf, 00 Most Rosen, 01 --IncreasedIncreasedIncreasedIncreased Kenefick, 02 Most Ripetti, 02 Most Matzel, 04 --IncreasedIncreasedIncreasedIncreased Altomare, 04 --IncreasedIncreasedIncreasedIncreased Matzel, 04 MostIncreasedIncreasedIncreasedIncreased Matzel, DCR 2004

SACRAL NERVE STIMULATION REVIEW – ANORECTAL PHYSIOLOGY Resting P Squeeze P Threshold V Urge V Max Tolerable V MaloufNEInconsistentNENEIncreased MatzelNEIncreasedNENENE GanioIncreasedIncreasedDecreasedDecreasedDecreased LeroiNEInconsistent RosenIncreasedIncreasedDecreasedDecreasedNE UludagNENE KenefickNEIncreasedDecreasedNEDecreased RipettiIncreasedIncreasedDecreasedNE-- MatzelNEIncreasedDecreasedNEIncreased AltomareNENENEDecreasedNE GanioIncreasedIncreasedDecreasedDecreased-- NE – no effect Matzel, DCR 2004

> SNS is effective > Consistent over time > FIQOL significantly improved in single and muticenter studies –Lifestyle –Coping,/behavior –Depression/self-perception –Embarrassment > Changes in anorectal physiology testing - variable SACRAL NERVE STIMULATION REVIEW - CONCLUSIONS Matzel, DCR 2004

SACRAL NERVE STIMULATION REVIEW > 106 reports reviewed > 266 underwent temporary stimulation > 149 underwent permanent stimulator (60%) > 41-75% achieved complete continence > % experienced improvement Jarrett, BJS 2004

Isolated sphincter defect Pudendal neuropathy Sphincteroplasty Alternative procedure Simple procedures Success Complex procedures Intact repair ACYST SECCA Perianal sepsis SNS Stim’d graciloplasty ABS Severe muscle loss Cardiac pacemaker yesno ?yes Failure Spinal deformity SNS ABS, SECCA, ACYST SNS, SG SNS Persistent Defect no