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VVA Ospemifene treatment and Overactive Bladder Symptoms improvement

Retrospective analysis in 46 women with vulvovaginal atrophy treated with ospemifene for 12 weeks: improvement in overactive bladder symptoms

Michele Carlo SchiaviDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and Correspondence[email protected]

Marzio Angelo ZulloDepartment of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy

Pierangelo FaianoDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Ottavia D’OriaDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Giovanni PrataDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Vanessa ColagiovanniDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Andrea GianniniDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Chiara Di TucciDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Giorgia PerniolaDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Violante Di DonatoDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Marco MontiDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Ludovico MuziiDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

Pierluigi Benedetti PaniciDepartment of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome “Sapienza”, Umberto I Hospital, Rome, Italy and

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Abstract

Aims: 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).

Methods: 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.

Results: 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.

Conclusion: Ospemifene is an effective potential therapy for postmenopausal women with VVA improving OAB symptoms and quality of life.

Chinese abstract

目的：本研究的目的是评估奥培米芬在改善绝经后女性外阴阴道萎缩（VVA）所致膀胱过度活动症状（OAB）中的有效性和安全性。

方法：46例VVA所致OAB绝经后女性患者被纳入研究, 所有患者均服用奥培米芬60 mg, 持续12周。且均在开始和12周时进行了临床检查, 3天排尿日记, 尿动力学检查, 子宫内膜超声测量、膀胱壁厚度（BWT）以及阴道健康指数（VHI）检测, 并完成了OAB-Q SF和UDI-6问卷调查。

结果：12周后, 逼尿肌过度活动患者从39％降至13％（p = 0.04）。12周前和12周后, 24 h平均减少尿量分别为（9.57 ± 2.12 和6.63 ± 1.22, p < 0.0001）, 尿急发作频率/24 h分别为（5.63 ± 1.46和1.44 ± 1.31, p < 0.0001）, 夜尿症发作分别为（3.17 ± 0.85和1.11 ± 1.18, p < 0.0001）尿失禁发作频率/24小时（分别为0.85 ± 0.96和0.33 ± 0.64, p = 0.003）。12周前和12周后UDI-6, OAB-Q症状评分表, OAB-Q（HRQL）评分分别为8.95 ± 0.91分和5.56 ± 1.40分、62.60 ± 14.70分和20.08 ± 10.83分以及18.71 ± 7.41分和79.45 ± 14.47分（p < 0.001）

结论：奥培米芬是绝经后VVA患者改善OAB症状和生活质量的有效治疗手段。

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The authors report no conflicts of interest

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Retrospective analysis in 46 women with vulvovaginal atrophy treated with ospemifene for 12 weeks: improvement in overactive bladder symptoms

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Retrospective analysis in 46 women with vulvovaginal atrophy treated with ospemifene for 12 weeks: improvement in overactive bladder symptoms

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