Objective: – To evaluate whether the benefits demonstrated after 6 months of treating vulvovaginal atrophy (VVA) with ospemifene and local vaginal estrogen therapy (LET) were maintained after 12 months. To assess the persistence and adherence to treatments, as well as the satisfaction of participants and associated factors. Methods: – Longitudinal, observational study conducted in 17 Italian gynecology centers involving women already under treatment (LET or ospemifene) or new users. Participants complete questionnaires at baseline (T0), after 3 (T3), 6 (T6), and 12 months (T12). The main outcome measures were treatment satisfaction, severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and Short Form-12 (SF-12) Health Survey. Results: – Among the 385 women included in the study, 145 (37.7%) were treated with ospemifene, and 240 (62.3%) with LET. Overall, 75.9% of women treated with ospemifene and 78.7% with LET completed the 12-month follow-up. In the ospemifene group, the treatment satisfaction score improved from 7.02 (95% CI, 6.64-7.39) at T3 to 8.32 (95% CI, 7.78-8.86) at T12 (P<0.0001), while in the LET group the score improved from 7.36 (95% CI, 7.06-7.66) to 7.79 (95% CI, 7.5-8.08) (P=0.001). In multivariate analysis, women treated with ospemifene had an almost threefold higher likelihood of reporting a clinically relevant improvement (effect size ≥0.5) in satisfaction score (OR=2.85; 95%CI, 1.33-6.11). The likelihood of moderate/severe VVA symptoms and urinary symptoms significantly decreased in both groups. DIVA and FSDS-R scores significantly improved in both groups. Conclusions: – The PatiEnt satisfactiON studY (PEONY) documents the high effectiveness, satisfaction, and persistence after 12 months with LET or ospemifene in women with VVA.
Treatment of vulvovaginal atrophy is associated with high levels of satisfaction and improves symptom severity and patient-reported outcomes: 12-month results of the PatieEnt satisfactiON studY (PEONY)
Nappi, Rossella E
2026-01-01
Abstract
Objective: – To evaluate whether the benefits demonstrated after 6 months of treating vulvovaginal atrophy (VVA) with ospemifene and local vaginal estrogen therapy (LET) were maintained after 12 months. To assess the persistence and adherence to treatments, as well as the satisfaction of participants and associated factors. Methods: – Longitudinal, observational study conducted in 17 Italian gynecology centers involving women already under treatment (LET or ospemifene) or new users. Participants complete questionnaires at baseline (T0), after 3 (T3), 6 (T6), and 12 months (T12). The main outcome measures were treatment satisfaction, severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and Short Form-12 (SF-12) Health Survey. Results: – Among the 385 women included in the study, 145 (37.7%) were treated with ospemifene, and 240 (62.3%) with LET. Overall, 75.9% of women treated with ospemifene and 78.7% with LET completed the 12-month follow-up. In the ospemifene group, the treatment satisfaction score improved from 7.02 (95% CI, 6.64-7.39) at T3 to 8.32 (95% CI, 7.78-8.86) at T12 (P<0.0001), while in the LET group the score improved from 7.36 (95% CI, 7.06-7.66) to 7.79 (95% CI, 7.5-8.08) (P=0.001). In multivariate analysis, women treated with ospemifene had an almost threefold higher likelihood of reporting a clinically relevant improvement (effect size ≥0.5) in satisfaction score (OR=2.85; 95%CI, 1.33-6.11). The likelihood of moderate/severe VVA symptoms and urinary symptoms significantly decreased in both groups. DIVA and FSDS-R scores significantly improved in both groups. Conclusions: – The PatiEnt satisfactiON studY (PEONY) documents the high effectiveness, satisfaction, and persistence after 12 months with LET or ospemifene in women with VVA.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
