Non-ablative Er:YAG for Recurrent Candidiasis

NCT06572488 | Completed

• 1 other identifier: CAND/01
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Candidiasis, Vulvovaginal; Candidiasis of Vagina; Candidiasis, Genital; Recurrent Candidiasis of Vagina; Infection, Candida; Vaginal Yeast Infections

Keywords

non-ablative; Er:YAG laser; Recurrent vaginal yeast infection; Recurrent vulvovaginal candidiasis; candidiasis; vaginal; genital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in lab cultures of vaginal swabs

  Change from Baseline at 3 and 9 months after last intervention

• Recording of frequency and severity of adverse effects related to laser treatment

  9 months

• Patient satisfaction with 5-point Likert scale

  Improvement from Baseline at 3 and 9 months after last intervention

Study Arms (1)

Active therapy with non-ablative Er:YAG laser

EXPERIMENTAL

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

Interventions

Non-ablative SMOOTH mode Er:YAG laser DEVICE

Four intravaginal treatments within four months.

Also known as: SMOOTH mode, non-ablative Er:YAG laser

Active therapy with non-ablative Er:YAG laser

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Espacio Gaspar Clinic: lead

Study Sites (1)

Uroclinica

Mendoza, Argentina

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Adrian Gaspar, MD

  Espacio Gaspar Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 27, 2024
• Study Start: January 3, 2019
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)