James Q. Pulvino, MD, FACOG OhioHealth Urogynecology Physicians Riverside Methodist Hospital Columbus, Ohio Learning Objectives To understand what Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are. Understand how to diagnose and treat POP and SUI. Be aware of different minimally invasive treatment options for POP and SUI and how robotics may play a role. Understand the risks and benefits each of these treatment options and how to choose for your patient. Apical POP – what is it? Refers to the downward displacement of the vaginal apex. Vaginal apex is either: Uterovaginal Vault Prolapse (Uterus and Cervix) Posthysterectomy Vaginal Vault Prolapse Cervix (s/p supracervical hysterectomy) Vaginal Cuff (s/p TAH, TVH or TLH) Incomplete vs. Complete Incomplete – to or near vaginal introitus but not beyond. Complete – descensus of leading edge beyond introitus. Apical POP Normal Pelvic Support Apical Prolapse POP - Epidemiology Affects millions of women Approximately 200,000 inpatient surgical procedures performed annually in United States. > $1 Billion spent on surgery alone. 11 – 19% of women will undergo surgery for POP and/or incontinence by age 80‐85. Up to 30% will require additional surgery for POP and/or incontinence surgery in life time. Projected population of women > 60 y.o. expected to increase by 72%. Women > 60 y.o. statistically more likely to seek care thus demand for treatment of pelvic floor disorders expected to increase – possibly at pace 2x that of general population growth! SUI – What is it? “The complaint of involuntary leakage of urine with effort, exertion, sneezing or coughing.” Abrams et al. Urology, 2003 No associated sensation of urgency, frequency or nocturia. SUI - Epidemiology Most common cause of urinary incontinence in young and middle aged women (< 60 years). Affects up to 35% of women. *Luber KM 2004 ~211,000 surgeries for this indication in 2010. *Wu et al. 2010 *Predicted to increase to ~310,000 per year by 2050. Often coexists with UUI/OAB “Wet” (MUI) in middle aged and older age groups. Epidemiology - SUI and POP Often co‐exist – especially in women with advanced POP (Stages II‐IV). SUI can be presenting symptom in conjunction with POP or be apparent only when POP is reduced/corrected (i.e. Occult SUI) Occult SUI can be seen in up to 13‐65% of patients following repair of advanced POP. *Swift S et al. 2005 *Ellerkmann RM et al. 2001 *Gutman RE et al. 2008 *Mouritsen L et al. 2003 Pathophysiology Pathophysiology of POP Support of vaginal apex derived from: Uterosacral and Cardinal Ligaments Endopelvic Fascia Neuromuscularly intact Levator Ani Muscle Defects/Disruptions at any of these levels likely contributes to apical POP. Rare to find isolated apical prolapse or isolated anterior or posterior prolapse . Same connective tissue, neural pathways, and muscles contribute to support. Apical Support Pathophysiology of Apical POP Risk factors for POP: Age Parity (Especially number of vaginal deliveries.) Family History of POP Postmenopausal State Repetitive Pressure/Trauma to Pelvic Floor Obesity, Chronic Cough (i.e. COPD), Constipation, Exercise, Work requiring repetitive lifting/straining, etc...) Race 3x more likely in caucasian women than african‐ american women. *Hysterectomy After hysterectomy risk of subsequent POP repair 5 fold in those with history of vaginal delivery, 8 fold in in those with history of prior surgery for POP or urinary incontinence and almost 13 fold in those with grade 2 or higher POP at time of hysterectomy. *Dallenbach P et al. 2007 Pathophysiology of SUI Loss of urethra’s ability to maintain intra‐urethral pressure greater than bladder pressure during times of increased intra‐abdominal pressure. Pathophysiology of SUI Pathophysiology of SUI Anatomical Defect “Hammock Theory” Urethra normally supported by endopelvic fascia and anterior vaginal wall. Increases in abdominal pressure forces urethra down onto these structures compressing urethra. Weakening of structures leads to hypermobility of the urethra with loss of compression and insufficient urethral pressure to maintain continence. Often associated with pregnancy/childbirth, aging, and repetitive stress on pelvic floor (i.e. smoking/chronic cough and obesity). Pathophysiology of SUI Neurological Defect Involves: Spinal sympathetic reflex that inhibits detrusor contraction during bladder filling and activates alpha adrenergic receptors in the urethra which contract urethra and increase its pressure Efferent innervations from pudendal nerve increases tone in the pelvic diaphragm and striated urethral sphincter. Damage in either area results in intrinsic sphincter deficiency (ISD) Pathophysiology - ISD Normal Urethra ISD Risk Factors/Causes Age – Increases with age (30 – 60 most prevalent). Obesity Parity Smoking Strenuous Activity/Repetitive Lifting ?Family History/Genetic Predisposition Evaluation History Physical Exam POP Q – assesses all compartments. Cough Stress Test ‐ POP reduced. Q‐tip test ( > 30 degrees) Postvoid Residual (PVR) Urinalysis Bladder Diary Evaluation Q-tip Test POP-Q Specialized Testing Multichannel Urodynamics Cystoscopy Specialized Testing Recurrent SUI. Mixed Urinary Incontinence (MUI). History of previous incontinence and/or prolapse repair. *Presence of POP. Urodynamics can detect up to 80% occult SUI. *Negative test does not guarantee that will not develop postoperatively but does significantly reduce rate. Treatment of Apical POP and SUI Treatment of Apical POP Pelvic Floor Exercises/Pelvic Floor Physical Therapy Pessary Surgery Abdominal Sacrocolpopexy. Uterosacral Ligament Suspension. Sacrospinous Ligament Suspension. Sacrocolpopexy (ASC) Open approach gold standard (85 – 90% success rates) (Price N, et al 2009) For repair of apical POP. Most anatomically correct of all repairs. Lower rates of recurrent POP, less postop dyspareunia and reoperation rates. Can be performed with standard laparoscopy or robotically‐assisted (RAL). RAL Sacrocolpopexy More recently adapted for use with robotics. RAL approach shows similar effectiveness and durability to open approach. Likely same proposed benefits as standard laparoscopy with added benefits of robotics: Superior Visualization Two magnifying wide‐angle cameras within laparoscope Image synchronization Provides 3‐dimensional imaging Depth perception Increased precision Advantages of RAL Movements are intuitive Eliminates “fulcrum effect” Instruments move just as your hands move, rather than as mirror image. Stabilization of instruments Robotic digital process allows scaling down of surgeon’s hand movements Creates “tremorless” surgery Advantages of RAL Increased degree of instrument movements Endowrist instruments 7 degrees of freedom Fingertip hand controls transposed to the tips of the instruments allows manipulation of wristed instruments similar to that of open surgery. Improved dexterity, maneuverability and precision. Improved knot tying – eliminates need for extracorporeal knot tying. Advantages of RAL Improved ergonomics Trocar resistance eradicated by man‐machine interface Surgeon sits comfortably console No longer standing at bedside for long periods No need to contort body or hands to position instruments Results in less surgeon fatigue and joint strain Laparoscopic Robotic Disadvantages of RAL Loss of haptics/tactile feedback Unable to sense depth of suture placement Increased risk of crush/tear injuries with retraction Rupture/Breaking of suture material with knot tying *With experience are able to compensate with improved visual feedback. Increased learning curve – higher level skill set. Longer operative time. RAL ASC vs. SL ASC Robotic and Standard approaches offer the improved vaginal support associated with open technique and the shorter recovery of the vaginal approaches. Similar complication and rates and short‐term outcomes. Both associated with longer operative times compared to open approach (1 – 2 hours). Longer operative time for RAL vs. SL (24‐67 minutes). RAL associated with higher cost. Both associated with higher rate of anterior compartment recurrences with laparoscopic approaches vs. open (18% vs. Costantini E. et al. 2016 2%). Long term studies lacking for both. Uterosacral Ligament Suspension Uterosacral ligaments are sutured to the vaginal apex. Treatment for apical POP. Vaginal vs. Laparoscopic. Alternative to ASC. Offers more anatomically correct repair of ASC (as compared with SSLF). No synthetic graft involved. Uterosacral Ligament Suspension Increased risk of ureteral injury (Up to 11%) regardless of approach. *Laparoscopic approach may reduce risk. RAL approach has been described. Likely same advantages/disadvantages as described for RAL ASC (i.e. knot tying, operative time, cost, etc….) Very little data on laparoscopic approach. Decreased blood loss and length of hospital stay compared to vaginal approach. (Price N, et al 2009) **Higher rates of anterior wall prolapse after USLS as compared with ASC – all approaches. *Rardin CR, et al. 2009 **Filmar GA, et al. 2014 Laparoscopic PVDR Treatment for cystocele with lateral wall defect. Performed vaginally or abdominally. Abdominal repair has been described with RAL. Reported success rates 76 – 93% Mostly case reports/observational studies. Often described with concomitant Burch. PVDR with Burch Treatment of SUI Pelvic floor exercises / Physical Therapy – Kegels Weight Loss Pharmacologic – (i.e. if MUI) Continence Ring Surgery Burch Cystourethropexy – Open/Laparoscopic/Robotic Assisted. Minimally Invasive Suburethral Sling Transurethral Bulking Injections Burch Cystourethropexy “Open” procedure gold standard for treatment of SUI for many years. 70‐90 % improvement /satisfaction rates. Invasive ‐ traditionally performed via laparotomy More invasive/dissection. Increased blood loss. Increased risk of infection. Longer hospital stay (2‐3 days). Slower return to preop activity level. Laparoscopic Burch New take on old procedure. Performed with standard laparoscopy since 1991. In comparison to open approach: (Vancaille and Schuessler 1991) Equal efficacy at least in short term. 78% vs. 83% at 18 months. (Dean NM et al. 2006) Less invasive. Improved visualization. Decreased rate of infection and intraoperative blood loss. Shorter hospital stay (1 vs. 2‐3 days.) Faster return to preoperative activity level. Decreased postoperative pain. Less narcotic use Improved cosmesis/aesthetics Shorter time of catheterization. Robotic Assisted Laparoscopic Burch May be useful if: Patient requests avoidance of synthetic graft or has contraindication to its use. Recurrent SUI. Performing concomitant abdominal POP repair : Abdominal Sacrocolpopexy (ASC) Uterosacral Ligament Suspension (USLS) Paravaginal Defect Repair (PVDR) Colpopexy and Urinary reduction Efforts (CARE) Trial Prophylactic Burch at time of sacrocolpopexy protective for SUI at 3 month and 2 year follow‐up. No clinically significant deleterious effects. Recommended prophylactic Burch at time of sacrocolpopexy for stress‐continent women who have a mobile urethra. Brubaker L, et al 2008 Suburethral/Midurethral Sling Safe and effective. Equal to open Burch. Superior to laparoscopic Burch Higher objective cure rates. (Price N et al. 2009) Minimally invasive. Smaller incisions. Less dissection. Less blood loss. Shorter operative time. Outpatient/Same day procedure. More cost effective. Durable Subjective cure rates 77 – 85% at 7 – 11 years postop. Nilsson CG et al. 2008 and Liapis A et al. 2008 Suburethral/Midurethral Sling Multiple approaches. Retropubic Transobturator Prepubic Single Incision Not all slings equal. TVT/Retropubic 85 – 90% cure or improvement rates at 5 years. Bottom Up vs. Top Down approach. Approximately equal success rates. (Ogah J et al. 2009) Retropubic approach also effective for those with ISD so long as UVJ hypermobility. Transobturator Sling (TOT) Slightly lower efficacy compared to retropubic approach. (Seklehner S et al. 2015) Especially ISD. Less risk of: Bladder perforation Bowel injury (i.e. prior abdominal surgery.) Postop voiding dysfunction (*minimal) Higher risk of: Neurovascular injury (obturator). Postoperative pain: Groin and perineal. Dyspareunia (1 – 9%). (Kaelin‐Gambirasio et al. 2009, Neuman M 2007) Single Incision Sling Anchored in urogenital diaphragm vs. obturator internus muscle. Benefits: Less tissue disruption. Decreased risk of visceral injury. Less risk of voiding dysfunction. Lower subjective and objective cure rates than TVT and TOT. Midurethral Sling – Mesh Erosion Risk of mesh erosion/exposure ranges from 1 – 3%. Recent FDA warning regarding placement of mesh via the vaginal approach for the treatment of pelvic organ prolapse. Midurethal slings and ASC excluded. Midurethral slings FDA approved and endorsed by AUGS as first line surgical treatment for SUI. Has lead to trend in increase alternative procedures but MUS still recommended first line treatment in most instances. Transurethral Bulking Injections Transurethral Bulking Injections SUI Intrinsic sphincter deficiency (ISD) with lack of hypermobility of the urethrovesical jucntion (UVJ). Elderly and those with multiple comorbidities. Women still considering childbearing. Unclear effects of pregnancy/delivery on other modalities (i.e TVT, Burch, etc….) Effectiveness: Initial improved/cure rates 70‐90% Actual cure rates 40‐60% Is biodegradable (Collagen) – reabsorbed over time. Gross M, Appel RA, 2003 Range 6 – 18 months Coaptite/Macroplastique – more durable/permanent. Still often require repeat injections periodically to maintain effectiveness at 1 – 2 year intervals. Conclusions/Recommendations POP and SUI are common debilitating issues that are easily diagnosed and treatable. Start conservative. For healthy women with Apical POP and SUI who desire surgical treatment and accept synthetic surgical materials ASC and midurethral sling best options based on current literature. RAL approaches may offer benefits over the open approaches with similar efficacy to open approach in appropriate surgical candidates. Conclusions/Recommendations If undergoing concomitant repair of POP midurethral sling and Burch acceptable depending on approach to POP repair. Burch (Open, SL and RAL) may have role if abdominal approach. Consider Burch procedure also in those with history of failed sling, history of mesh erosion or increased risk for erosion. Bulking injections reserved for those who cannot tolerate surgery, ISD with fixed urethra or have failed other options. Questions? References 1.) Abrams P, Cardoza L, Fall M, Griffiths D, Rosier P, Ulsmsten, U. “The standardization of terminology in lower urinary tract function: report from the standardization subcommittee of the International Continence Society.“ Urology, 61:37,2003 2.) Price N, Jackson S. “Advances in laparoscopic techniques in pelvic reconstructive surgery for prolapse and incontinence.” Maturitas, 62 (2009) 276 – 280. 3.) Neuman M. “TVT-obturator: short term data on an operative procedure for the cure of female stress urinary incontinence performed on 300 patients.” Eur Urol 2007; 51: 1083 4.) Kaelin-Gambirasio I, Jacob S, Boulvain M, et al. “Complications associated with transobutrator procedures; analysis of 233 consecutive cases with a 27 month follow-up.” BMC Womens Health 2009, 9:28 5.) Luber KM. The definition , prevalence, and risk factors for stress urinary incontinence.”Rev Urol 2004; 6 Suppl 3: S3. 6.) Richter HE, Albo ME, Zyczynski HM, et al. “Retropubic versus transobturator midurethral slings for stress incontinence.”N Engl J Med 2010; 362: 2066. 7.) Nilsson CG, Palva K, Rezapour M, Falconer C. “Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence.”Int Urologynecol J Pelvic Floor Dysfunct 2008; 19: 1043. 8.) Liapis A. Bakas P, Creatsas G. “Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5 and 7 year followup.” Int Urogyncol J Pelvic Floor Dysfunct 2008; 19: 1509. 9) Brubaker L, Nygaard I, Richter H, et al. Two year outcome s after sacrocolpopexy with and without Burch to prevent stress urinary incontinence. Obstet Gynecol. 2008 July; 112(1): 49 – 55. 10.) Jelovsek JE, Barber MD, Karram MM, et al. Randomized trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow up.” BJOG 2008; 115: 219. References 11.) Dallenbach P, Kaelin-Gambirasio I, Dubuisson JB, Boulvain M. “Risk factors for pelvic organ prolapse repair after hysterectomy.” Obstet Gynecol 2007; 110:625. 12.) Swift S, Woodman P, O’Boyle A, et al. “Pelvic Organ Support Study (POSST): the distribution , clinical definition , and epidemiologic condition of the pelvic support defects.” Am J Obstet Gynecol 2005; 192:795. 13.) Ellerkmann RM, Cundiff GW, Melick CF, et al. “Correlation of symptoms with location and severity of pelvic organ prolapse.” Am J Obstet Gynecol 2001; 185:1332. 14.) Gutman RE, Ford DE, Quiroz LH, et al. “Is there a pelvic organ prolapse threshold that predicts pelvic floor symptoms?” Am J Obstet Gynecol 2008; 199:683.e1. 15.) 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