A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
Background: Recurrent vulvovaginal candidiasis (RVVC) is a common obstinate vulvovaginal
inflammation in gynecology. At present, the pathogenesis of RVVC is not clear. In recent
years, it is emphasized that the changes of vaginal microecological environment play an
important role in the occurrence and development of RVVC. The treatment of RVVC can be
divided into intensive treatment and consolidation treatment. Currently, local antifungal
treatment is the main treatment regimen. While it is difficult and had an insufficient effect
on prevention from recurrence of clinical signs and the improvement of vaginal mycological
status in long term. Besides, there is no mature consolidation treatment regimen at home and
abroad. Through the current application of the fractional CO2 laser in the treatment of
atrophic vaginitis, it is confirmed that local irradiation of the fractional CO2 laser on
vulva and vagina can regenerate and repair mucosal tissue, enhance the function of vaginal
epithelial cells, gradually restore the normal pH value of vagina, improve vaginal
microecological environment, restore the proportion of vaginal flora and reduce the
recurrence rate of RVVC. This trial aims to explore the efficacy of two consolidation therapy
schemes: the fractional CO2 laser and traditional antifungal drugs.
Methods/Design: The ongoing study will include 200 RVVC patients who voluntarily joined the
study and signed the informed consent form the Second Affiliated Hospital of WMU during
December 2019 to March 2022. After patients were cured by transvaginal local drug intensive
therapy, participants will be randomly divided into control group (n = 100) and experimental
group (n = 100). The control group continue to receive a monthly course of vaginal local drug
consolidation therapy for 6 months, while the experimental group will be given monthly local
vaginal CO2 laser consolidation therapy for 3 months. The vaginal secretions samples of RVVC
patients will be collected before intensive therapy, after intensive therapy and at the end
of consolidation therapy, and the species abundance and structure of vaginal flora were
detected and analyzed. In the same period, 5 healthy women of childbearing age were recruited
as the normal control group and the volunteers do not take any treatment. The vaginal
secretions samples of 5 volunteers will be collected when signing the informed consent to
detect and analyze the species abundance and structure of vaginal flora.
The patients with RVVC will be followed up for 3, 6 and 12 months after the treatment and
vaginal secretions samples will be collected for vaginal flora structure detection to compare
the vaginal microecological environment. For recurrent patients, the investigators will carry
out targeted treatment, and again collect vaginal secretions sample to detect and analyze the
species abundance and structure of vaginal flora.
Objectives: The aim of this study is to compare the effects of fractional CO2 laser
consolidation therapy and traditional antifungal consolidation therapy for RVVC, and assess
the role of fractional CO2 laser in changes of vaginal microecological environment and
recurrence rate of VVC after consolidation treatment.
Phase:
N/A
Details
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University