12/1/13. What are Pelvic Floor Disorders? What is the Pelvic Floor? Facts. Prevalence of Urinary InconOnence. What s New in Pelvic Floor Disorders?

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1 What are Pelvic Floor Disorders? Urinary Control Problems - InconOnence or leakage of urine Prolapse of pelvic organs - Vagina, bladder, rectum What s New in Pelvic Floor Disorders? Kimberly Kenton MD, MS Professor, Obstetrics & Gynecology and Urology Chief, Female Pelvic Medicine & ReconstrucOve Surgery Director, Women s Integrated Pelvic Health Program Bowel Control Problems - Fecal InconOnence What is the Pelvic Floor? Muscles, ligaments and connecove Ossue in the lowest part of the pelvis Supports internal organs: - Bladder - Uterus - Rectum - Vagina Facts Very common - Urinary control problems affect millions US women >60% of post-menopausal women >30% young women 1 in 3 women will experience a PFD in her lifetime Prevalence of Urinary InconOnence 30% 25% 20% 1 in 4 younger women 8% Incontinence 1 Hypertension 2 Depression 3 Diabetes 4 1. AHCPR. Rockville, Md: US Dept of Health and Human Services; American Heart Association. Electronic citation. 3. American Family Physician. Electronic citation. 4. NIDDK. Electronic citation. Tahereh E., et al. The Frequency of Pelvic Floor Dysfunc9ons and their Risk Factors in Women aged Journal of Family and Reproduc9ve Health 6(2), June

2 Facts 1 in 5 paoents with urinary control problem also report bowel control problem Nearly 19% lifeome risk of having surgery for pelvic floor disorder Myths It is normal. - To lose control of bladder or bowel with aging Surgery is the only opoon Surgery doesn t work Long recovery and lifestyle (lieing restricoons) Don t ask, don t tell Risk Factors for PFD When do women seek help? 26% of women wait > 5- years 33% wait 1 to 5 years Aging Smoking Childbirth 41% seek help within 1 year Obesity ConsOpaOon Norton, P A et al. Distress and Delay Associated With Urinary Incontinence. BMJ, 297(5), November Who Treats Pelvic Floor Disorders? Women s Integrated Pelvic Health Program Mul9disciplinary approach to pelvic floor disorders Female Pelvic Medicine & ReconstrucOve Surgery - Urogynecology - Urology Colon & Rectal Surgery Physical Therapy Female Pelvic Medicine & ReconstrucOve Surgery Urogynecology & Urology u American Boards of Obstetrics & Gynecology and Urology - Recognized need to specialized care beyond general training to provide high quality care for women with PFD - Jointly accredited fellows programs u 2011: American Board of Medical SpecialOes officially recognized specialty u 2013: ABOG & ABU cerofied the first individual doctors 2

3 Colon & Rectal Surgery Primary CerOficaOon in General Surgery AddiOonal Fellowship Training & CerOficaOon in Colon & Rectal Surgery - Anne Marie Boller MD, MA, FACS - Amy Halverson MD, FACS What is new? Level I Evidence - Physical therapy - Pessary - Botox - NeuromodulaOon (UI and FI) - Midurethral Slings - Laparoscopic & robooc prolapse repair Stress Urinary InconOnence Urgency Urinary InconOnence Overac9ve Bladder Bladder Bladder Bladder contracts spontaneously Urethra Urethral Sphincter (Knot) Urethra Urethral Sphincter (Knot) Minimally Invasive Midurethral Slings NEJM 362;22 june 3, 2010 ClinicalTrials.gov number, NCT

4 Trial Of Midurethral Slings 597 women randomized to retropubic or transobturator sling Physical Therapy vs Sling RCT 460 Women with Stress Incon9nence 1- year primary outcome - SaOsfacOon 93% (retropubic) vs 92% (transobturator) 5- year outcomes - SaOsfacOon HIGH but declining Retropubic 79% Transobturator 85% Mesh erosion rates remain low UIVALENT for SUCCESS 49% in PT crossed over to MUS 11% in MUS crossed over to PT SubjecOve Improvement (IIT) - 91% MUS - 64% PT 2013 Women who crossed over to MUS similar outcomes to those who had MUS - both superior to PT IniOal MUS as compared to PT - Higher rates of subjecove improvement - Higher rates subjecove and objecove cure ATLAS RCT comparing conservaove treatments for Stress InconOnence ATLAS 1- year Sa9sfac9on Rates - Pessary - Pelvic Floor Muscle Training (Kegels) - CombinaOon Physical therapy 54% Pessary 50% Combined 54% - SIGNIFICANTLY improved women s quality of life and bother from urinary incononence - BOTH effecove NON- SURGICAL TREATMENTS for certain types of incononence Botox Overac9ve bladder Office procedure - Women with incononence not responsive to other treatment 2012 First line treatment Botox vs Bladder MedicaOons 27% vs 13% completely dry at 6 months Lasts up to 6-9 months Pelvic Organ Prolapse Nearly half of women ages have Pelvic organ prolapse 4

5 Prolapse = Hernia hernia Uterus Normal Support Loss of Support (Uterus) Uterus Normal Vaginal Descent Normal? ½ of women presenting for GYN care have POP to or beyond hymen POP- Q Staging: All women (n=497) 51% 0% 3% % 43% 6% ½ of women 6% presenting for GYN care POP to or beyond hymen Swift, S., Am J Obstet Gynecol, 2000, 183:2 Success Varied With DefiniOon 322 Women who underwent Prolapse Repair (CARE Trial) How evaluate POP outcomes? Stage 0 19% Stage 0/I 58% No bulge symptoms 90% No POP > hymen 94% Definition of Success 5

6 PaOents want to: Anatomic Criteria Only Anatomic Criteria + No Bulge No Bulge OpOmize - SaOsfacOon - Outcomes Anatomy FuncOonal - Quality of life Minimize - ComplicaOon - Recovery ComplicaOons Outcomes What matters to patient s? Bulge gone PaOent saosfacoon No bulge now has - Stress incononence - Urgency incononence - Dyspareunia - ComplicaOon - Mesh erosion. Open Route Of Apical POP Repair? Laparoscopic/ Robotic Reconstructive Vaginal Pham T et al MESH ASC No MESH Uterosacral NO MESH Uterosacral SSLS MESH Kit No kit Sacrocolpopexy (ASC) How should we select the best opera9on for POP repair?!know normal w Know which outcomes meaningful to paoent w Know individual woman s goals w Know procedures Open Laparoscopic RoboOc Mesh - Vagina to sacrum Level 1 Data - Anatomic superiority - Durability - Increased complicaoons When compared to vaginal approach 6

7 Minimally Invasive Prolapse Surgery Robo9c Surgery Laparoscopic & RoboOc Key hole surgery Duplicate open technique Improved durability Advantages Decrease complicaoons Quicker recovery 8 mm 5 or 10 mm 5 mm RoboOc Sacrocolpopexy Open versus Laparoscopic Sacrocolpopexy LAS Trial - 3 Centers in UK - Equivalence trial Soe polypropylene mesh - Polydiaxanone on vagina; Permanent suture to sacrum - Reperitonealized 1- year - ObjecOve (point C) and PGI ( much bexer ) equivalent OPEN & LSC ASC EQUIVALENT RCT LASC vs RASC Uterosacral Ligament Suspension (USLS) PARAISO 2011 Primary outcome = OR Ome - ñ OR Ome & pain robot No DIFFERENCE - Anatomic, symptom, QOL outcomes - Anatomic outcomes - ComplicaOons Cost $1936 ñ with robot KENTON, IN PRESS Primary outcome = COST - NO difference hospital costs - 12,586 vs 11573, p= NO difference RASC & LASC costs in first 6 weeks - 13,867 vs 12,170, p=.060 No DIFFERENCE - Anatomic, symptom, QOL outcomes - Anatomic outcomes - ComplicaOons 7

8 SSLS OPTIMAL Uterosacral vs Sacropinous: Ligament A vs B 2 Approaches - David Nichols - Michigan ModificaOon Extra- peritoneal Suture vaginal to SSL Anterior wall site of failure Deviates vagina to one side Many new treatment op9ons for trea9ng PFD Surgical Non- surgical NOT one size fits all. On behalf of ALL the women suffering with Pelvic Floor Disorders, THANK YOU for your axenoon! Increasing high- quality data to guide treatment & more on the way Balancing adverse outcomes & success 8