Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study

Sue W Goldstein, Ashley G Winter, Irwin Goldstein, Sue W Goldstein, Ashley G Winter, Irwin Goldstein

Abstract

Introduction: Ospemifene, an oral selective estrogen receptor modulator approved for the treatment of mild to moderate dyspareunia from menopause, has been shown to moderate sexual pain and vaginal epithelial cell characteristics. However, no prospective vulvoscopic studies have been performed.

Aim: To examine, in menopausal women taking ospemifene 60 mg daily, changes to the vulva, vestibule, urethral meatus, and vaginal region over 20 weeks using vulvoscopy in a prospective open-label pilot study.

Methods: Vulvoscopic photographs taken at screening and the end of therapy assessed for changes in the appearance of the vulva, vestibule, urethral meatus, and vagina rated by a single reviewer using a 10-parameter Likert rating scale, the Vulvoscopic Genital Tissue Appearance Scale (VGTA). In addition, the cotton-tipped swab test and subject diary scores were assessed over the 20-week treatment period and compared before and after the intervention using Wilcoxon signed-rank test.

Main outcome measure: Changes in VGTA score from baseline to end of study.

Results: 8 subjects (age = 59 ± 4.7 years) completed all visits and were included in the analysis of vulvoscopic photographs (n = 258). There were significant changes during the study period for urethral meatal prominence, introital stenosis, vestibular pallor, vestibular erythema, mucosal moisture, vaginal rugation, and anterior wall prominence (P < .05). Total pain score during cotton-tipped swab testing decreased from 11 (interquartile range = 10-16) before the intervention to 1 (interquartile range = 0-3) at the end of the study. Quantitative diary analysis indicated an increase in the number of sexual events, decrease in rates of pain during foreplay and intercourse, and decrease in use of lubricant at study completion (P < .05).

Conclusions: Ospemifene 60 mg daily for 20 weeks showed improvement in physical examination findings in this prospective study of menopausal women with dyspareunia, as documented on vulvoscopic photography. These changes were consistent with improvements in subject-reported pain and sexual function. Goldstein SW, Winter AG, Goldstein I. Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study. Sex Med 2018;6:154-161.

Keywords: Dyspareunia; Ospemifene; Urethral meatus; Vestibule; Vulva; Vulvoscopy.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1
Figure 1
Schematic showing study protocol, including duration of treatment with ospemifene and number of vulvoscopic photographs examined.
Figure 2
Figure 2
Vulvoscopic photographs representing parameters in the Vulvoscopic Genital Tissue Appearance Scale that showed significant improvement from baseline (top row) to end of study (bottom row). Photographs from various subjects are representative of the study population. Note significant changes in some tissues, such as the urethral meatus, vestibule, and anterior vaginal wall, that are androgenic.
Figure 3
Figure 3
Vulvoscopic photographs from subject 004. Vulvoscopic photographs were taken in order. Panels a to d show baseline evaluations at 1:00, 3:00, 6:00, and 9:00 o’clock, respectively. Panels e to h show end-of-study evaluations at 1:00, 3:00, 6:00, and 9:00 o’clock, respectively. These images show improvement in the Vulvoscopic Genital Tissue Appearance Scale for urethral meatal prominence, introital stenosis, vestibular pallor, vestibular erythema, and vestibular moisture.
Figure 4
Figure 4
Graph shows significant improvement in total score of cotton-tipped swab (Q-tip) testing over time for each subject in the study.

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Source: PubMed

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