Non-ablative Er:YAG for Recurrent Candidiasis

Exploring the Effects of Non-ablative Er:YAG Laser on Patients Suffering From Recurrent Vulvovaginal Candidiasis

The objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative Er:YAG laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (RVVC). Eligible patients have received 4 laser therapies within four moths and will be assessed at baseline, 3 months and 9 months after last laser therapy.

The effects of laser therapy have been assessed by following the vaginal microbial status, by assessing the five bothersome symptoms related to vaginal infection (burning, itching, dyspareunia, dysuria, and abnormal discharge), by assessing the overall patient satisfaction, and throughout the study the safety of the laser therapy has been monitored.

Study Overview

• Status: Completed
• Conditions: Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina; Vaginal Yeast Infections; Candidiasis of Vagina; Candidiasis, Genital; Infection, Candida
• Intervention / Treatment: Device: Non-ablative SMOOTH mode Er:YAG laser

Detailed Description

Genital candidiasis is a common fungal infection that affects both men and women, though it is more frequently observed in women. It is estimated that up to 75% of women will experience at least one episode of vulvovaginal candidiasis (VVC) during their lifetime. The primary causative agents are Candida albicans and other non-albicans pathogenic fungal species.

The likelihood of developing genital candidiasis can be influenced by factors such as age and hormonal changes. Women of reproductive age, especially those who are pregnant, using hormonal contraceptives, or experiencing hormonal fluctuations, are at higher risk. The highest prevalence rate, 9%, is reported among women aged 25 to 34 years. Antibiotic use, which can disrupt the body's microbial balance, is a known risk factor for genital candidiasis, along with other factors like obesity, uncontrolled diabetes, corticosteroid use, chronic stress, and certain lifestyle choices.

Clinical guidelines recommend oral fluconazole or itraconazole as the first-line treatment for recurrent vulvovaginal candidiasis (RVVC). However, after stopping maintenance therapy, a recurrence rate of 40%-50% is expected. While clinical resistance to antifungal agents is rare, overexposure to azoles can lead to resistant strains of C. albicans. Additionally, non-albicans Candida species, such as C. glabrata, often show dose-dependent susceptibility or resistance to fluconazole and other azole agents, and their prevalence is increasing. Given the limited therapeutic options, innovative treatment strategies are necessary.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Mendoza, Argentina
    • Uroclinica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult women (> 18 years)
• diagnosis of recurrent vaginal yeast infection (> 4 infection per year)

Exclusion Criteria:

• patients having contraindications to laser therapy (epilepsy, pregnancy, acute systemic infection)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active therapy with non-ablative Er:YAG laser; Patients underwent four laser sessions with non-ablative SMOOTH Er:YAG laser therapy, with 1 moth interval between sessions	Device: Non-ablative SMOOTH mode Er:YAG laser; Four intravaginal treatments within four months.; Other Names: SMOOTH mode; non-ablative Er:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of bothersome symptoms (burning sensation,/irritation, itching or soreness, dyspareunia, dysuria, abnormal vaginal discharge	Patients were required to assess the symptom severity on a 0-10 VAS (Visual Analog Pain) scale, 0 referring to "absence of symptom" and 10 referring to "intolerable symptom"	Change from Baseline at 3 and 9 months after last intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lab cultures of vaginal swabs	Lab cultures of vaginal secretion on Sabouraud dextrose agar (SDA) were performed for diagnosis and determination of lead pathogen.	Change from Baseline at 3 and 9 months after last intervention
Recording of frequency and severity of adverse effects related to laser treatment	Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.	9 months
Patient satisfaction with 5-point Likert scale	Patients were asked to assess their global satisfaction with the treatment on a 5-point Likert scale (1-Very unsatisfied, 2-Unsatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied).	Improvement from Baseline at 3 and 9 months after last intervention

Collaborators and Investigators

• Sponsor: Espacio Gaspar Clinic
• Investigators: Principal Investigator: Adrian Gaspar, MD, Espacio Gaspar Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: candidiasis; vaginal; Er:YAG laser; genital; non-ablative; Recurrent vulvovaginal candidiasis; Recurrent vaginal yeast infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infections; Communicable Diseases; Candidiasis; Recurrence; Candidiasis, Vulvovaginal
• Other Study ID Numbers: CAND/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No