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METHODS: Population

◼ Study population: Pooled data from 4 PFDN trials Sexual Activity and (2002 - 2018) ◼ CARE1 – Open sacrocolpopexy ± Burch/Paravaginal after Surgical Repair of Vaginal repair ◼ OPUS2 – Variety of vaginal POP repairs ± midurethral sling Lukacz ES, Chermansky C, Gantz M, Harvie H, Korbly NB, ◼ OPTIMAL3 - ULS vs. SSLF ± native tissue repair Mazloomdoost D, Sridhar A, Rahn D, Varner R; ± pelvic therapy for the Disorders Network ◼ SUPER4 – Mesh augmented antero-apical hysteropexy vs. TVH/ULS ± native tissue repair ± Funding: NIH/NICHD midurethral sling

1 Brubaker 2006, 2Wei 2012, 3Barber 2014, 4Nager 2016 & 2018

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Disclosures METHODS: Outcomes

◼Risk factors via standard assessments: • Lukacz ES: Consultant: Axonics; Resarch Support: Boston Scientific, ◼ Baseline demographics, medical/surgical history, Uroplasty/Cogentix, Pfizer; Royalties: UpToDate POP surgical approach & concomitant UI procedures • Chermansky C: • Gantz M: Research Support, Boston Scientific ◼ • Harvie H: none Sexual Function (PISQ-12/PISQ-IR): • Korbly NB: none ◼ Baseline & 1 year • Mazloomdoost D: Research Support, Boston Scientific ◼ Activity in last 3 months (yes/no) • Sridhar A: none ◼ Dyspareunia (yes/no) – in past 3 months • Rahn D: Research Support, Pfizer • Varner R: Research Support, Boston Scientific

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OBJECTIVES METHODS: Definitions & Statistics

◼Dyspareunia = “usually or always” ◼ “Do you feel during sexual intercourse?” in sexually ◼ To describe sexual activity, dyspareunia rates and risks active women for postoperative dyspareunia after OR (POP) ◼ “Does fear of pain during sexual intercourse restrict your ◼ Transvaginal native tissue repairs (e.g. uterosacral or activity?” in not sexually active women sacrospinous ligament fixation ± anterior repair, posterior repair) ◼De novo dyspareunia - sexually active without dyspareunia at baseline with new onset dyspareunia at 12 mo ◼ Transvaginal graft augmented (mesh/biologic) repairs ◼ Abdominal sacrocolpopexy ◼Persistent dyspareunia - women with dyspareunia at baseline with present dyspareunia at 12 mo

◼Statistics: Bivariate analyses and adjusted logistic regression

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RESULTS: Sexual activity RESULTS: Surgical factors – bivariate analysis

◼97% (1297/1337) enrolled in 4 trials underwent reconstruction Surgical Repairs 12 mo 12 mo p ◼72% (932/1297) had baseline and 12 mo PISQ data Dyspareunia No Dyspareunia value % (n/N) % (n/N) ◼Baseline Sexual Activity = 57% (534/932) Antero-apical 0.2625 ◼ Active without dyspareunia = 48% (445/932) Native Tissue 60% (38/63) 63.7% (359/564) ◼ Active with dyspareunia = 9% (89/932) Transvaginal Mesh/Graft 15.9% (10/63) 9.4% (53/564) ◼ Not active due to fear of dyspareunia =10% (93/932) Sacrocolpopexy 23.8% (5/63) 27.0% (152/564) ◼ Not active due to other reasons = 33% (305/932) Posterior 0.2295 Not Performed 39.7% (25/63) 49.9 (281/563) Baseline 12 mo p value Native Tissue TV 58.7% (37/63) 48.5 (273/563) Sexually Activity (n/N) Mesh/Graft 1.6 (1/63) 1.6% (9/563) Overall 57% (534/932) 63% (585/932) < 0.0001 Concomitant UI Surgery 71.2% (37/52) 76.3% (366/480) 0.4154 New onset - 25% (101/398) Discontinued - 9% (50/534) Concomitant 52.4% (33/63) 56.6 (319/564) 0.5261

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RESULTS: Dyspareunia risk factor analysis RESULTS: Multivariable analysis 12mo Dyspareunia

◼627 women were sexually active (n=534) or inactive due to No fear of dyspareunia (n=93) at baseline Dyspareunia Dyspareunia Adjusted OR Covariate (N=63) (N=564) (95% CI) P-value ◼ Demographics Post-menopausal 85.7% (54/63) 77.5% (437/564) 1.8 (0.8, 3.9) 0.1444 ◼ Mean age 58.4 (9.9) yrs, BMI 27.8 (4.9) kg/m2 Current Smoker 12.0% (6/50) 6.7% (34/508) * Too few to include in model ◼ Median Vaginal Parity 3 POPQ Stage ≥ III 60.3% (38/63) 70.4% (397/564) 0.8 (0.4, 1.4) 0.4154 ◼ 83% White, 78% menopausal, 69% POPQ ≥ III Baseline 73.0% (46/63) 24.1% (136/564) 7.8 (4.2, 14.4) <0.0001 Dyspareunia Baseline 12 mo p value* Dyspareunia Baseline Bothersome 36.5% (23/63) 22.3% (126/564) 1.2 (0.7, 2.3) 0.5624 Overall 29% (182/627) 10% (63/627) <0.0001 de novo - 4% (17/445) Anteroapical vs. Native Tissue Repair: resolved - 75% (136/182) Transvaginal 15.9% (10/63) 9.4% (53/564) 1.3 (0.6, 2.9) 0.5326 Mesh/Graft Sacrocolpopexy * Chi squared 23.8% (15/63) 27.0% (152/564) 1.1 (0.6, 2.2) 0.7326 8 11

RESULTS: Baseline factors - bivariate analysis RESULTS: Persistent & de novo dyspareunia

12 mo 12 mo Baseline Dyspareunia No Dyspareunia • No significant factors associated with persistent Characteristic (n/N) (n/N) P-value dyspareunia Post-menopausal 85.7% (54/63) 77.5% (437/564) 0.1327 Current Smoker 12.0% (6/50) 6.7% (34/508) 0.1568 • Too few women (n=17) with de novo dyspareunia to perform modeling POPQ Stage ≥ III 60.3% (38/63) 70.4% (397/564) 0.0748 Baseline 73.0% (46/63) 24.1% (136/564) <.0001 Dyspareunia Baseline Bothersome Pelvic 36.5% (23/63) 22.3% (126/564) 0.0122 Pain

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CONCLUSIONS

◼Dyspareunia was common (1 in 5) in these women undergoing surgery for POP ◼de novo dyspareunia rates were low (<5%) ◼Dyspareunia improved in 3 out of 4 women after repair ◼The presence of baseline dyspareunia was the only significant risk factor for persistent symptoms at 12 months ◼ Type of repair was not associated with dyspareunia ◼ No predictors for persistent dyspareunia ◼Surgeons may use these data in shared decision making regarding surgical approach and post operative expectations

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