Disclosures. Non Surgical Treatment of Pelvic Organ Prolapse Holly E. Richter, PhD, MD, FACOG, FACS. Non-Surgical Treatment of Pelvic Organ Prolapse

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1 Non-Surgical Treatment of Pelvic Organ Prolapse Disclosures No relevant disclosures Learning Objectives Discuss non-surgical options for symptomatic anterior, apical, and posterior prolapse Discuss role of pelvic floor physical therapy in management of prolapse List factors which impact successful pessary fitting for prolapse, including: stage, genital hiatus, uterus, etc Fit and manage prolapse pessaries Discuss the advantages and disadvantages of the following pessary types Ring with and without support Donut Gellhorn Gehrung Lever Cube Discuss the role of estrogen replacement therapy (systemic vs local) in women using pessary for prolapse Explain how recommendations differ based on presence or absence of uterus

2 Prevalence Rates of Pelvic Floor Disorders in Women from the National Health and Nutrition Examination Survey (NHANES) Prolapse: Weighted prevalence rate 2.9%, 95% CI %; with increasing age 4.1%, 95% CI1.1, 7.1% Nygaard et al, 2008 Who are candidates? Conservative (non-surgical) management of POP should be offered to all patients -Minimum morbidity and mortality -Minimally invasive -Does not preclude surgery -Satisfaction high PATIENT MOTIVATION is key to success Hay Smith et al, ICI, 2009 Conservative Therapy = Less Risk The absolute risk of death is low for urogynecologic surgery Older women = higher risk of mortality/morbidity following urogynecologic surgery: -Increasing age increased risk of death (compared to women <60 years old): years, OR 3.4 [95% CI ] years, OR 4.9 [95% CI ] 80 years, OR 13.6 [95% CI ] Risk of peri-operative complications higher in women 80 years of age and older (OR 1.4 [95% CI ]) 1.5]) compared with younger women

3 Who chooses surgical vs. Non-surgical? Prospective cohort study in women with symptomatic prolapse Offered surgical versus pessary treatment 251 women chose surgery, 429 women chose pessary no difference regarding prolapse stage, leading edge, previous POP surgery and hysterectomy Women choosing surgery were: Younger (58 vs 66) More bothered with dragging, g, lower abdominal pain, need for vaginal digitation In general, women choosing surgery had more severe symptoms related to bowel emptying, sexual function and quality of life Overall POP symptom distress was comparable Treatment approach may not be totally driven by symptoms Offer to all patients!! Kapoor, 2009 Non-surgical Treatment Options for Symptomatic Vaginal Prolapse What is the evidence? Expectant Management/Observation Pelvic Muscle Exercises Pessary Expectant Management Allows patient to monitor symptoms Ideal for patients with minimal bother Would not offer: Patients with difficulty emptying bowels and bladder Significant vaginal erosion Inability to reduce prolapse

4 Is the prolapse going to get worse? Expectant Management 64 symptomatic women chose observation (158 selected treatment) Majority Stage 2 or 3 Median follow-up 16 months (range 6-91 months) 78% no change in leading edge, 19% progression, 3% regression On multivariate analysis, no variables associated with change 63% continued observation, 38% pessary/surgery Bottom Line: Natural history of POP = minimal change in women declining intervention Gilchrist et al, 2012 Pelvic Floor Muscle Exercises Few studies exist for PFMT/behavioral therapy treatment of pelvic organ prolapse Most are small (until recently), descriptive Short-term t follow-up Patients with mild/moderate prolapse Pelvic Floor Muscle Training For The Treatment of Pelvic Organ Prolapse Pelvic Organ Prolapse Physiotherapy, POPPY Trial Hagen and colleagues randomized 447 women with newly diagnosed symptomatic prolapse to individualized pelvic floor muscle training or lifestyle advice Stage 1-3 Intervention group 5 visits PFMT over 16 weeks 1 outcome -12 month validated questionnaire Hagen et al, Lancet 2013

5 POPPY Trial, cont. At 12 months the intervention group demonstrated fewer prolapse symptoms and more likely to report their prolapse as better There were no adverse events related to treatment Hagen et al, Lancet 2013 Bottom Line for PFMT for POP May expect subjective and objective improvements Most likely best for stage I and II POP Low risk Requires motivated patient Pessary Pelvic organ prolapse treatments have had a variable course through history..

6 History of the Pessary 1550 BC Ebers papyrus references remedies to allow the womb of a woman to slip into its place Honey and petroleum applied to uterus Fumes References also seen in Hindu, Greek, and Roman works 400 BC - Hippocrates Succussion Suspend a woman upside down and aggressively move her up and down for 3-5 minutes Gravity and the shaking motion would return the organs to their normal position Shah SM et al, 2006 Hot oil, astringents, and wool plugs were used Leg binding Fumigation to repel the uterus back into place Pomegranates warmed in lukewarm wine were inserted

7 932 AD Manual reduction of prolapse, insertion of a wool pessary and crossing of the legs 1559 AD Replacement for the pomegranate pessary Sponge wrapped in string, dipped in wax and covered with oil or butter Various 19 th century pessaries Walters MD and Karram MM, th century: ring, Hodge, and Smith pessaries came into use 1950s: hard rubber replaced with polystyrene Further refinement has been made to pessaries Modern day pessaries non-reactive silicone various designs and sizes

8 Reasons to Consider Pessary Trial Symptomatic prolapse & patient s desire for nonsurgical intervention Medical contraindications to surgery Desire to postpone/delay surgical intervention Vaginal ulcerations caused by severe POP Younger women with prolapse or incontinence who plan to have children or additional children Diagnostic tool (prediction of surgical outcome) Prevention of increasing prolapse Atnip et al 2012; Clemons 2012 Do Pessaries Work? Short-term term studies (2-6 months): Satisfaction and continued use 81% (range 63-92%); 59% (40-77%) ITT Cundiff et al, 2007; Wu et al, 1997; Nguyen et al, 2005; Maito et al, 2006; Handa and Jones, 2002; Clemons, Medium-term (1-2 years): Satisfaction and continued use 62% (53-83%); 40% (30-63%) ITT Powers et al, 2006; Cundiff et al, 2007; Wu et al, 1997; Nguyen et al, 2005; Handa and Jones, 2002; Friedman et al, 2010; Clemons, 2004; Patel et al, Long-term Outcomes Lone and colleagues performed a prospective observational study of subjects successfully fit (187/246) 86.1% successfully utilized the pessary over 5 years Minor complications included: Pain or discomfort (6.9%) Excoriation or bleeding (3.2%) Disimpaction or constipation (2.0%) 1 A retrospective study involving 167 women described a 14% continuation rate over 14 years 2 1. Lone et al, 2011; 2. Sarma et al, 2009

9 Patient Selection Considerations Patient s motivation Current sexual function Type and duration of exercise regimen/ other activity level Current condition of vaginal walls/cervix Surgical History Other considerations Patient s cognitive status Manual dexterity Support system Potential Contraindications Local infection Atrophy Exposed vaginal foreign body (mesh) Latex sensitivity (inflatoball) Non-compliance Most Important: Patient cannot comply with follow-up (dementia or transportation issues) Persistent vaginal erosions Sexually active women unable to remove/insert pessary Clemons, 2012

10 Pessary Characteristics Made of silicone Do not retain odors Non-allergenic Durable May be autoclaved 2 main types 1. Support Ring (with or without support), lever, Gehrung, incontinence ring or dish 2. Space-filling Gellhorn, donut, cube, inflato-ball Support Space-filling Most Common Types Used for POP Ring Gellhorn Cube Donut

11 Practical If you only have two pessary types in your office make them a ring with support and a Gellhorn Which is better: Ring with Support or Gellhorn? Randomized cross-over over trial with 134 women Outcomes included satisfaction, quality of life questionnaires Cundiff, 2007 Both pessary types were equally effective in relieving symptoms of protrusion and voiding dysfunction 87% of patients could be fitted 45% wore a pessary for 3 months 7% were dissatisfied with both younger women and those with prior POP surgery Older and more parous women preferred ring pessaries Women without prior hysterectomies or prolapse surgery preferred Gellhorn pessaries Cundiff GW et al, 2007.

12 Real World Experience 84% of women are initially fitted with a pessary Two to three pessaries usually tried Ring pessary (size 3, 4, and 5) used 70-74% 74% Gellhorn and donut used in 26-29% 29% Women with UI 78-80% 80% used incontinence ring or dish pessaries 11-20% used ring pessaries Clemons 2004, Wu 1997, Moore 1999, Robert 2002 Successful pessary fitting A retrospective chart review of 1216 patients Patients on local estrogen therapy Those fit with: Ring Ring with support Gellhorn Patients with a previous history of abdominal prolapse surgery (compared to vaginal approach) Successful fitting in 2 visits Usually 2 pessary types attempted Hanson LM et al, Unsuccessful fitting Prior prolapse surgery Prior hysterectomy Short vaginal length ( 6 cm) Wide vaginal introitus (4 fingerbreadths) Concurrent POP and UI Younger age Obesity

13 Who continues pessary use at 1 year? Prospective evaluation of 59 women who were satisfied with their pessary 2 months post-fitting 73% continued pessary use Factors associated with continued pessary use: Older age (65 years old was cut-off) Poor surgical risk Factors associated with surgery: Sexual activity Stress incontinence Stage III-IV IV posterior wall prolapse Clemons JL et al, Anything to help improve pessary continuation?* Identifying patient-selected goals may help Prospective study of 80 women Asked to identify up to 5 goals at fitting (bladder/urinary, activity, social relationships, etc.) Followed for 1 year Those who met goals were more likely to continue use Komesu YM et al, Fitting a pessary Start with support type (vs space-filling) -More easily removed and inserted -May allow intercourse while in place -Often more comfortable Clemons, 2012

14 Ring with and without support Pros Able to fold (easiest to insert/remove) Prolapse and UI Intercourse possible while in place Drainage holes (with support) Cons May not be effective for higher stage prolapse with enlarged genital hiatus Gellhorn Pros Base provides good support to apex (convex surface) Often used if ring does not stay in place due to introital laxity Drainage holes Cons More difficult to insert/remove Remove for sexual activity Donut Pros More difficult to insert and remove Good for massive vault/uterovaginal prolapse/large posterior defects Cons Genital hiatus must be of sufficient i size to admit, yet smaller than pessary Increased vaginal discharge

15 Gehrung Rarely used - difficult to place Tends to rotate out of proper position Can be manually molded to fit type and size of prolapse (convexity toward bulge) Lever (Smith, Hodge and Risser) Originally designed for uterine retroversion (used for uterine prolapse/cystocele) Difficult placement Can leave in for sexual intercourse Rarely used Cube (6 concave sides) Suction - difficult removal Highly effective for many types of prolapse Cannot be left in place long periods: erosions/discharge Role of ERT (systemic vs local) in Women Using Pessary for Prolapse, cont. NAMS published a position statement intravaginal estrogen more effective than systemic for urogenital atrophy progestogen generally not indicated when low-dose intra-vaginal estrogen is administered locally for atrophy (individualize), NAMS, Menopause, 2010 and 2007 Cochrane review estrogen creams, tablets, and vaginal rings were all equally effective at management of atrophy, Suckling et al, Cochrane Database Syst Rev, 2006 Recommendation to use estrogen cream up to 3X per week with continued pessary use, Arias et al, 2008; Sarma et al, 2009 Common Problems Erosion If an erosion does not heal consider a biopsy Most common side effects of pessary use are: Vaginal discharge Odor

16 Vaginitis Bacterial vaginosis Complications De novo incontinence Bleeding Ulceration of vagina Embedded/Incarcerated cervix or uterus Severe Complications Visceral obstruction Vesicovaginal and rectovaginal fistula Fecal impaction Hd Hydronephrosis and urosepsis Cancer 2.6% of cervical cancers and 30% of vaginal cancers in a series of 2500 patients treated in France since /96 tumors occurred at the site of contact Mean time from insertion to diagnosis was 18 years Schnaub et al, Severe Complications PubMed search: 39 cases of major complications related to pessary use were identified VVF n=8 Urologic complications n=5 RVF n=4 Bowel complications n=3 Impacted pessaries n=19 Almost always related to a neglected pessary (91%) Arias, 2008.

17 Bottom-Line Complications Severe complications are rare Almost all are preventable with close vigilance Discuss importance of follow-up with the patient and family Treat erosions early Conclusions Offer to all patients with POP Data regarding long-term satisfaction and continued use, unclear Should be a part of the full spectrum of treatment options for patients with POP References Culligan P. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119: Hagen S, Starck D, Glazener C, et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomized controlled trial. Lancet 2014;383: Clemons JL. Vaginal pessary treatment of prolapse and incontinence. pessary treatment-of-prolapse-and-incontinence. Retrieved 2/24/14. Atnip S, O Dell K. Vaginal support pessaries: Indications for use and fitting strategies. Urol Nursing 2012;32: Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Review, 2011, Issue 12 Atnip SD. Pessary use and management for pelvic organ prolapse. Obstet Gynecol Clin N Am 2009;36:

18 References Cundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, Handa VL. The PESSRI study; symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol 2007;196:405.e1-8 Adams EJ, Thomson AJM, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Review, 2009, Issue 1 Oliver R, Thakar R, Sultan AH. The history and usage of the vaginal pessary; a review. Eur J Obstet Gynecol Reprod Biol 2011;156: Lamers BHC, Broekman BMW, Milani AL. Pessary treatment for pelvic organ prolapse and health-related quality of life; a review. Int Urogynecol J 2011;22: Arias BE, Ridgeway B, Barber MD. Complications of neglected vaginal pessaries; case presentation and literature review. Int Urogynecol J 2008;19: