Quality of life in women with chronic recurrent vulvovaginal candidosis: A sub-analysis of the prospective multicentre phase IIb/III Prof-001 study.
Mycoses
; 66(9): 767-773, 2023 Sep.
Article
em En
| MEDLINE
| ID: mdl-37147720
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 < .05). A reduction in pain frequency during or after sexual intercourse in the 6-month period occurred in 124 (66.3%) women.CONCLUSIONS:
Women with RVVC had high QoL and sexual health impairment; however, a 6-months maintenance treatment resulted in effective improvement in QoL and sexual health.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Candidíase Mucocutânea Crônica
/
Candidíase Vulvovaginal
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Mycoses
Assunto da revista:
MICROBIOLOGIA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Áustria