The aim of this study was to assess the effectiveness and safety of ospemifene in the improvement of overactive bladder (OAB) symptoms in postmenopausal women affected by vulvovaginal atrophy (VVA).
Forty-six postmenopausal patients affected by VVA with OAB syndrome were enrolled for the study. All patients received Ospemifene 60 mg for 12 weeks. Clinical examination, 3-day voiding diary, urodynamic testing, ultrasound measurement of endometrial and bladder wall thickness (BWT) and the Vaginal Health Index (VHI) were performed at baseline and 12 weeks. Patients completed the OAB-Q SF and UDI-6.
After 12-weeks, the number of patients with detrusor overactivity decreased from 39% to 13% (p = 0.04). The reduction in the mean number in 24 h of voids (9.57 ± 2.12 vs. 6.63 ± 1.22, p < 0.0001), urgent micturition episodes/24 h (5.63 ± 1.46 vs. 1.44 ± 1.31, p < 0.0001), nocturia episodes (3.17 ± 0.85 vs. 1.11 ± 1.18, p < 0.0001), urinary incontinence episodes/24 h (0.85 ± 0.96 vs. 0.33 ± 0.64, p = 0.003) was observed. The UDI-6, OAB-Q symptoms, OAB-Q (HRQL) scores were 8.95 ± 0.91 vs. 5.56 ± 1.40, 62.60 ± 14.70 vs. 20.08 ± 10.83 and 18.71 ± 7.41 vs. 79.45 ± 14.47 (p < 0.001) before and after 12 weeks.
Ospemifene is an effective potential therapy for postmenopausal women with VVA improving OAB symptoms and quality of life.
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2017 May 11 [Epub]
Michele Carlo Schiavi, Marzio Angelo Zullo, Pierangelo Faiano, Ottavia D'Oria, Giovanni Prata, Vanessa Colagiovanni, Andrea Giannini, Chiara Di Tucci, Giorgia Perniola, Violante Di Donato, Marco Monti, Ludovico Muzii, Pierluigi Benedetti Panici
a Department of Gynecological and Obstetric Sciences, and Urological Sciences , University of Rome "Sapienza", Umberto I Hospital , Rome , Italy and., b Department of Surgery-Week Surgery, Campus Biomedico , University of Rome , Rome , Italy.