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Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Sponsor: Patricia Lordelo
Summary
Vaginal disorders, including vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and genitourinary syndrome of menopause (GSM), are highly prevalent conditions that significantly affect women's quality of life and sexual health. These disorders are associated with inflammatory changes, vaginal dysbiosis, and symptoms such as pruritus, abnormal vaginal discharge, dryness, and dyspareunia. In this context, photobiomodulation has emerged as a noninvasive therapeutic approach with anti-inflammatory and tissue-repair properties. This study is a randomized clinical trial designed to compare the therapeutic response to blue LED photobiomodulation (401 ± 5 nm) delivered through home-based and outpatient treatment protocols. A total of 150 women aged 18 to 75 years with a diagnosis of GSM, BV, or VVC will be enrolled and randomly assigned to one of two treatment groups. Clinical and laboratory assessments will be performed before and after treatment. Participants will also complete the Female Sexual Function Index (FSFI) and the 36-Item Short Form Health Survey (SF-36). Outcomes will include the evaluation of gynecological signs and symptoms, sexual function, quality of life, treatment adherence, and adverse events. The anticipated risks are minimal and primarily related to potential discomfort during gynecological examinations and possible embarrassment associated with discussing sensitive health information. The study is expected to demonstrate that photobiomodulation may improve clinical and functional outcomes, representing a safe, non-hormonal therapeutic alternative for the management of vaginal disorders.
Official title: Therapeutic Response to Photobiomodulation in Home-Based and Outpatient Protocols for Vaginal Dysfunctions: A Randomized Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-07-30
Completion Date
2028-05-20
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Blue LED Photobiomodulation
Blue LED photobiomodulation (401 ± 5 nm) delivered through a vaginal light-emitting device. Participants will receive treatment according to the assigned protocol (home-based or outpatient). For participants with Genitourinary Syndrome of Menopause, treatment will consist of 8-minute sessions performed three times per week for a total of 24 sessions. For participants with Bacterial Vaginosis or Vulvovaginal Candidiasis, treatment will consist of 15-minute sessions performed twice weekly for a total of 8 sessions.
Locations (1)
Escola Bahiana de Medicina e Saúde Pública
Salvador, Estado de Bahia, Brazil