What are we talking about? Symptoms. Prolapse Risk Factors. Vaginal bulge 1 Splinting. ?? Pelvic pressure Back pain 1 Urinary complaints 2

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Options for Vaginal Prolapse What are we talking about? Michelle Y. Morrill, M.D. Director of Urogynecology The Permanente Medical Group Kaiser, San Francisco Assistant Professor, Volunteer Faculty Department of Obstetrics and Gynecology University of California, San Francisco Normal relaxation of the vaginal walls (30-40% of women, 98% of postmenopausal women) 1 Vaginal bulge or something falling out of the vagina 2 Descent of the apex, anterior and or posterior of the vagina (almost 50% of women) 3 1 Nygaard et al. Pelvic Organ Prolapse in Older Women: Prevalence and Risk Factors Obstet Gynecol 2004;104:489 97. 2 Tan et al. Predictive value of prolapse symptoms: a large database study. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):203-9 3 ACOG Practice Bulletin #85 Pelvic Organ Prolapse, September 2007 Symptoms Prolapse Risk Factors Vaginal bulge 1 Splinting?? Pelvic pressure Back pain 1 Urinary complaints 2 1 Swift et al. Correlation of symptoms with degree of pelvic organ support in a general population of women:what is pelvic organ prolapse? (Am J Obstet Gynecol 2003;189:372-9 2 Sutherland. Should asymptomatic anterior pelvic organ prolapse be corrected to treat irritative urinary symptoms? Curr Urol Rep. 2010 Sep;11(5):338-42. Nygaard 2004 (WHI) Age Education (college worse) Vaginal parity Weight of largest baby Miedel 2009 (Swedes) Family history of POP Hx of deficient CT (varicose viens, hernia, hemorrhoids) BMI, waist circumfrence Heavy lifting job Low impact exercise (vs. none or high impact)

Epidemiology Evaluation ~3-8% POP Prevalence 1,2 11% Lifetime risk of surgery for prolapse or incontinence 3 Olsen et al 30% of surgeries were repeats**» 33/393 were >1 repeat 1 Nygaard et al. Prevalence of Symptomatic Pelvic Floor Disorders in US Women. JAMA 2008;300(11):1311-1316 2 Lukacz et al. Parity, Mode of Delivery, and Pelvic Floor Disorders. Obstet Gynecol 2006;107:1253 60 3 Olsen et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Baden Walker half-way» Grade 0-4 POPQ» cm above or below the hymen Patient must be standing or straining Evaluate each compartment (anterior, apex and posterior) separately Options for Treatment Do Nothing? Do Nothing Physical Therapy Symptom-directed therapy Pessary Surgery Prolapse is not dangerous Reassure the patient

Do Nothing? Do Nothing? 412 WHI subjects (postmenopausal) with at least 2 Baden-Walker evaluations Progression and regression nearly equal Grade 1 prolapse more likely to improve than worsen 259 women in WHI at one site had at least 2 POPQ exams 1 and 3 year change of at least 1 cm» Patients with prolapse above the hymen were more likely to progress» Patients with prolapse beyond the hymen were more likely to regress >2cm worsening in 5.8% after 1y >2cm improvement in 1.2% after 1y Handa et al. Progression and remission of pelvic organ prolapse: A longitudinal study of menopausal women. AJOG (2004) 190, 27-32. Bradley et al. Natural History of Pelvic Organ Prolapse in Postmenopausal Women. Obstet Gynecol 2007;109:848 54) Physical Therapy Physical Therapy 109 Patients randomized to 3 sets of 8 12 maximum PFM contractions daily or no specific PFM instruction All participant advised to decrease straining 6 month follow-up Table: Patients who had an improvement in stage of prolapse Prolapse PFM training Stage I 0 0 Controls Stage II 16.7% 3.4% Stage III 35.7% 30% Braekken et al. Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial. Am J Obstet Gynecol 2010;203:170.e1-7

Physical Therapy Symptom Directed Therapy 109 Patients randomized to 3 sets of 8 12 maximum PFM contractions daily or no specific PFM instruction All participant advised to decrease straining 6 month follow-up Table: Patients who had an improvement in prolapse symptoms Decreased bother PFM training N=58 Controls N=50 67% 42% Weight control?» Gain bad» Loss doesn t help either 1 Avoid straining?» Behavior training» Treat constipation Braekken et al. Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial. Am J Obstet Gynecol 2010;203:170.e1-7 1 Kudish et al. Effect of Weight Change on Natural History of Pelvic Organ Prolapse. Obstet Gynecol 2009;113 Pessary Pessary Almost any patient can be a candidate» Exceptions Poor compliance (loss to follow-up)?vaginal infection Latex allergy (no latex Inflato-Ball) Can significantly improve symptoms and quality of life 1,2 1 Patel et al. Impact of pessary use on prolapse symptoms, quality of life, and body image. Am J Obstet Gynecol 2010;202:499. 2 Cundiff et al. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol 2007;196:405. Fitting» POPQ not very helpful» Short vaginal length and large genital hiatus decrease success 1 TRIAL and ERROR patient expectations! 1 Clemons, JL, Aguilar, VC, Tillinghast, TA, et al. Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse. Am J Obstet Gynecol 2004; 190:345.

Pessary Management Surgery Removal» By patient» In office 1 Erosions» Move / remove pessary» Vaginal estrogen, Trimo-San Identify the defect(s)» Apical» Anterior» Posterior (sorry about the evidence) 1 Gorti et al. Evaluation of vaginal pessary management: a UK-based survey. J Obstet Gynaecol. 2009 Feb;29(2):129-31 Surgery - Apical Surgery - Apical Important part of advanced prolapse repair Abdominal sacrocolpopexy superior to Vaginal sacrospinous suspension 1 Meta analysis of uterosacral ligament suspension 2» Median f/u 25m» 98% successful apical suspension (stage 0 or 1)» Uterosacral suspension does not adequately treat anterior prolapse 1 Maher et al. for Cochrane Group Surgical management of pelvic organ prolapse in women. 2010 2 Margulies et al. Outcomes of transvaginal uterosacral ligament suspension:systematic review and metaanalysis. AJOG Feb 2010. Systematic Review sacrocolpopexy vs. traditional vaginal repair vs. vaginal mesh kits through Jan 2008 with 3m f/u» Traditional vaginal (>7,800 pts) >2.5 y mean f/u 3.9% re-operation for prolapse» Sacrocolpopexy (>5,600 pts) >2y f/u 2.3% re-operation for prolapse» Vaginal mesh kits (>3,400 pts) Almost 1.5y f/u 1.3% re-operation for prolapse 1 Diwadkar et al. Complication and Reoperation Rates After Apical Vaginal Prolapse Surgical Repair A Systematic Review. Obstet Gynecol 2009;113:367 73.

Surgery - Apical Surgery - Apical Systematic Review sacrocolpopexy vs. traditional vaginal repair vs. vaginal mesh kits through Jan 2008 with 3m f/u» Traditional vaginal (>7,800 pts) >2.5 y mean f/u 5.8% re-operation overall» Sacrocolpopexy (>5,600 pts) >2y f/u 7.1% re-operation overall» Vaginal mesh kits (>3,400 pts) Almost 1.5y f/u 8.5% re-operation overall 1 Diwadkar et al. Complication and Reoperation Rates After Apical Vaginal Prolapse Surgical Repair A Systematic Review. Obstet Gynecol 2009;113:367 73. Colpocleisis» Effective 1 93% Stage 2 at 1y 94% satisfied or very satisfied at 1y» Safer? Less blood loss 2 Faster 2 1 Fitzgerald et al. Pelvic support, pelvic symptoms, and patient satisfaction after colpocleisis. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1603-9. 2 Denehy et al. Modified Le Fort partial colpocleisis with Kelly urethral plication and posterior colpoperineoplasty in the medically compromised elderly: A comparison with vaginal hysterectomy, anterior colporrhaphy, and posterior colpoperineoplasty. AJOG 1995;173:1697-702. Surgery - Anterior Surgery - Posterior Systematic reviews: Anterior repair augmented with mesh superior to colporrhaphy by objective (but not subjective) outcomes 1,2 OARS trial: 99 women randomized to colporrhaphy, Pelvicol or Mesh for anterior repair» 2y data on 75 subjects presented at AUGS 2010 Objective success Subjective success 1 Maher et al. for Cochrane Group Surgical management of pelvic organ prolapse in women. 2010 2 Sung et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008 Nov;112(5):1131-42. Colporrhaphy Pelvicol augment Mesh augment 43% 54% 85% p<0.02 88.5% 87.5% 96.4% Trans-vaginal repair is superior to transrectal repair 1 Traditional colporrhaphy = Graft augment 2 1 Maher et al. for Cochrane Group Surgical management of pelvic organ prolapse in women. 2010 2 Sung et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008 Nov;112(5):1131-42.

Surgery - Posterior Surgery - Posterior The Evidence is variable Identify the defect» Posterior vaginal wall (site specific?)» Perineum / Perineal Body Caution: Defecatory complaints are frequently d/t abnormal stool consistency or defecatory dysfunction Kudish and Iglesia. Posterior Wall Prolapse and Repair. CLINICAL OBSTETRICS AND GYNECOLOGY Volume 53, Number 1, 59 71 Surgery Vaginal Mesh Prolapse Surgery and Incontinence Miller et al. presented 5 year Prolift (formerly Total Vaginal Mesh) AUGS 2010:» 85 procedures, 90% done for anterior or combined prolapse» 66 available for f/u at 5y» 22% of patients had stage 2 recurrence in same compartment» 33% of patients had stage 2 recurrence overall» 7.5% re-op for prolapse» 9/85 re-op for mesh exposure, 2 rectovaginal fistulas CARE study At 2y: 12% Burch, 25% control had bothersome SUI (p = 0.004) Occult Stress Incontinence Testing 3m post-op» Positive test: no Burch 60% -> Burch 37% SUI» Negative test: no Burch 37% -> Burch 20% SUI But how relevant is this now?

Prolapse Surgery and Incontinence Summary Occult Stress Incontinence» Cochrane (meta-analysis) 1 Continence surgery does not significantly reduce post-op stress incontinence Significant heterogeneity in studies Future: OPUS 2» Women without SUI, having apical and/or anterior suspension» Randomized to TVT (Ethicon) or sham incisions Prolapse symptoms? Bothersome vaginal bulge Treatment options» Physical Therapy» Symptom-directed therapy» Pessary never know until you try» Surgery Identify the defect 1 Maher et al. for Cochrane Group Surgical management of pelvic organ prolapse in women. 2010 2 Wei et al. for PFDN Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial design and methods. Clinical Trials 2009; 6: 162 171.