Quality of life in women with chronic recurrent vulvovaginal candidosis: A sub-analysis of the prospective multicentre phase IIb/III Prof-001 study

Abstract

Background: Chronic recurrent vulvovaginal candidosis (RVVC), defined as three or more episodes of vulvovaginal candidosis per year, significantly impairs quality of life (QoL) and sexual health. Objectives: The primary objective of this study was to assess health-related QoL in women with RVVC using validated questionnaires before and after treatment. The secondary objective was to analyse the effect of RVVC on women's sexual health. Patients/Methods: This was a sub-analysis of a randomised, controlled, double-blinded study titled ‘A phase IIb/III, parallel-arm, randomized, active-controlled, double-blind, double-dummy, multicenter, non-inferiority study in patients with recurrent vulvovaginal candidosis to compare the clinical efficacy, safety and tolerability of topically administered ProF-001 (Candiplus®) to oral fluconazole, which was conducted at 35 study sites in Austria, Poland and Slovakia. QoL was assessed using the European Quality of Life (EQ) five-dimension five-level scale (EQ-5D-5L) and visual analogue scale (EQ-VAS) questionnaires, followed by specific questions regarding sexuality. Results: From 2019 to 2021, 360 of 432 (83.3%) women with RVVC had accomplished a 6-months maintenance treatment and were enrolled in this sub-analysis. The EQ-5D-5L and EQ-VAS scores demonstrated improved QoL in 137 (65.2%) and 159 (75.4%) women after 6 months of maintenance treatment. Each individual aspect of sexual health significantly improved (all p