9/24/2015. Incontinence and Prolapse 2015 Primary Care Update CME Symposium. Objectives. Mark Memo, DO, FACS NEO Urology September 25-27

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1 Incontinence and Prolapse 2015 Primary Care Update CME Symposium Mark Memo, DO, FACS NEO Urology September Objectives Incontinence Pelvic Organ Prolapse Vaginal Mesh Litigation 1

2 Urinary Incontinence (UI) Stress urinary incontinence (SUI) Urge urinary incontinence (UUI) Mixed urinary incontinence (MUI) Continuous incontinence VVF vs. GU anomaly Functional incontinence Dementia vs. immobility Overflow incontinence BPH, NGB UI General Facts 33 million people suffer from UI In 2000, estimated cost was 19.5 billion Can affect men and women, children to adults Less than 50% will discuss with their healthcare provider 70% of NH residents were placed for bowel and urinary incontinence UI General Facts Continued SUI 50% Mixed 24% Urge 16% 74% of patient stated they waited longer than should of to seek treatment 26% did now any treatment for UI existed 78% are frustrated with UI 42% are embarrassed (has a significant impact on their socialization) 2

3 SUI Intrinsic sphincter deficiency (ISD) Urethral hypermobility (UH) ISD 3

4 UH SUI Risk Factors Age Parity Route of Delivery Obesity Menopause Smoking history Chronic cough Constipation Radiation SUI Conservative Treatment Pads supportive No FDA approved meds at present Physical Therapy Behavioral Timed voiding Pelvic Floor Muscle Training (Kegel s) Biofeedback 4

5 SUI Surgical Treatment Endoscopic bulking agents Open colposuspension Burch or MMK Vaginal Sling vs. Pubovaginal Sling Artificial urinary sphincter - AUS SUI Sling (Mesh) Treatment Mesh has been used since 1968 There were 60 different companies that make sling worldwide Vaginal mesh was FDA approved for SUI in 1996 There have been different kinds of mesh The most commonly employed today is soft polypropylene In the past the big 4 Johnson and Johnson CR Bard American Medical Systems Boston Scientific SUI Sling AMS RetroArc - Retropubic Sparc - Suprapubic Monarc Transobturator MiniArc Minisling More than 1 million women have received AMS slings 85%-94% effective 5

6 Sparc Mesh AUS SUI Sling Adverse Complications Pain Infection/Inflammation Mesh erosion/extrusion Fistula UI Urinary retention Voiding dysfunction Nerve damage Bladder/Bowel perforation Hematoma Dyspareunia 6

7 SUI - Conclusion Any Questions before moving on? UUI General (OAB) Key S/SX frequency, urgency, nocturia Dry vs. Wet The exact etiology remains unknown Most is idiopathic Mostly in women, can affect men 43% of all women Remember, voiding is primarily a parasympathic event 7

8 UUI - Diagnosis H&P Urinary diary UA and C&S Cystoscopy UDS PVR UUI Conservative Treatment Caffeine restriction Recommend regular BM s Dietary modification Behavioral modification UUI Pharmacological Intervention Anticholinergics Toviaz/Detrol Ditropan/Oxybutnin Vesicare Enablex Santura Oxytrol patch (OTC) Gelnique Beta 3 Agonist Myrbetriq 8

9 UUI Non-pharmacological Interventions Percutaneous Tibial Nerve Stimulation (PTNS) Sacral Neuromodulation Onaboulinumtoxin A Bladder Augmentation UUI PTNS (Urgent PC) 34 gauge needle is placed near the medial malleolus The needle is connected to a battery powered stimulator Each treatment is 30 minutes They occur weekly for 12 weeks in total Tibial nerve has input from S % respond 15% keep the response Maintenance therapy may need to be started 9

10 UUI Neuromodulation (Interstim) This has been present FDA approved since 2002 The theory is focus mild electrical impulse on the nerves that help control the bladder There are 2 ways patient can be tested PNE vs. Staged approach technique UUI Interstim testing Place a fine lead on the S3 nerve route Confirmed with a Bellow response and large toe flexion This can be done in the office vs. the OR The OR is a formal lead vs. the office is testing lead The patient has a trial period If they respond then they can have the formal unit implanted surgically The unit is made by Medtronic The unit is the same as for cardiology UUI - Interstim About 80% respond 90% improvement rate The unit is around $10,000 The battery last 5-7 years The total cost in the long term is less vs. office visits, meds, pads, UTI s, and risk of hospitalization 10% explantation rate 10

11 Interstim UUI - Botox FDA approved in 2013 Can be done in the office vs. OR 20 injections given to the bladder mucosa Last about 6 months 6% retention rate Very high satisfaction rates Botox 11

12 UUI Bladder Augmentation Started in the 1950 s A loop of bowel is de-tubularized and reconfigured The bladder is bi-valved The bowel is attached The patient must learn CIC Rarely done Is very affective Bladder Augmentation UUI Conclusion Any questions before moving on? 12

13 Mixed Urinary Incontinence (MUI) This is a combination of SUI and UUI Can check UDS Focus on the patient complaint UDS Vaginal Mesh Litigation Incontinence has been documented for 2000 years 1949 MMK was pioneered (Bladder lift) 1950 Mesh was used for the first time for adbominal hernias 1960 Burch (Stitch reconfiguration) 1973 Stamey procedure 1981 Raz procedure (Very similar to current day approach 1996 FDA approved vaginal mesh for incontinence (Kits) 2002 FDA cleared the first mesh for POP 13

14 Vaginal Mesh Litigation 2006 AMS produced the Perigee and Apogee for POP (much large piece of mesh, they were the first kits to the market for POP In 2007, other companies starting bladder prolapse mesh kits to market Ethicon, Boston Scientific, Coloplast, Cook, Bard AMS in 2009, came out with the best solution to date the Anterior Elevate This is currently used and has good outcomes Perigee Anterior Elevate 14

15 Vaginal Mesh Litigation From 2008 to 2010, FDA had 2,874 medical device reports (MDR) 1,503 were for POP In 2010 alone about 300,000 meshes for POP were used in total, also about 260,000 meshes for SUI July of 2011 FDA produced an update on the safety and effectiveness There was a X5 increased risk in complications The most common complication was vaginal mesh extrusion FDA did not remove the mesh, but made recommendations Vaginal Mesh Litigation This was sign to the legal community to start fishing 23,569 cases were brought again Ethicon 19,093 AMS 15,429 Boston Scientific 10,525 Bard 1,870 Coloplast 288 Cook Vaginal Mesh Litigation AMS, now Aphrodite, is the only to settle for 2.8 billion, for all their cases They did state that no additional cases could be brought against them 22 physicians were named 11 were thrown out Boston Scientific decided to push each cased individually The verdict for the first cases was for 100,000 million 15

16 Conclusion Any questions? Also, would like to mention, NEO Urology is expanding Nick Styn, MD For referral to Nick or our practice

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