Objective: To evaluate the efficacy of low-dose, intravaginal estriol ovules in postmenopausal women with stress urinary incontinence (SUI) before and after transobturator tape (TOT) placement, assessing vaginal health, quality of life (QoL), and sexual function.
Methods: Ninety-six postmenopausal women affected by SUI and scheduled for TOT placement were enrolled. Women were randomized and divided into two groups through 1:1 at baseline (T0): study group (group A, n = 48) and control group (group B, n = 48). Group A was treated daily for 16 weeks with an intravaginal ovule containing 0.03 mg estriol. Vaginal epithelium maturation, QoL, and sexual function were investigated by using the Vaginal Maturation Index (VMI), Short Form-36 (SF-36) questionnaire, and Female Sexual Function Index (FSFI) questionnaire at baseline (T0), before surgery (T1), and 8 weeks after surgery (T2), respectively.
Results: Thirty-six women from group A and 44 women from group B completed the study. The VMI improved in group A at T1 (T1 [43.1] vs T0 [38.1]; P = 0.04) and T2 (T2 [47.8] vs T0 [38.1]; P = 0.001). The physical index score of the QoL improved only after surgery in group A (T2 [49.4] vs T0 [39.7]; P = 0.001). On the contrary, the mental index score improved at T1 [T1 (41.9) vs T0 (37.9), (P = 0.02)] and at T2 [T2 (49.6) vs T0 (37.9), P = 0.001]. Group B had improvement of the physical (45.6 vs 39.4; P = 0.001) and mental (43.6 vs 38.9; P = 0.002) index scores at T2. Sexual function improved in group A at T1 (13.9 vs 18.6; P = 0.001) and at T2 (13.9 vs 25.2; P = 0.001), and in group B at T2 (14 vs 17.2; P = 0.001). Moreover, it improved after TOT placement more in group A than in group B (P = 0.001).
Conclusions: Ultralow-dose topical vaginal ovules containing 0.03 mg estriol administrated before and after TOT placement could improve the vaginal epithelium maturation of postmenopausal women affected by SUI. Moreover, vaginal estriol ovules also improved the surgical outcome investigated by SF-36 and FSFI.