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.
Women aged 18 to 75 years.
Clinical and/or laboratory-confirmed diagnosis of Genitourinary Syndrome of - Menopause (GSM), Bacterial Vaginosis (BV), or Vulvovaginal Candidiasis (VVC), according to established diagnostic criteria.
Ability to understand study procedures and provide written informed consent.
Willingness to comply with study procedures and follow-up assessments.
Pregnancy.
Use of a pacemaker or other implanted electronic medical device.
Active gynecological malignancy or suspicion of gynecological cancer.
Neurological and/or psychiatric disorders associated with cognitive impairment that may interfere with understanding study procedures.
Parallel
Blue LED Photobiomodulation
DeviceBlue 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.
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Treatment groupsSee each treatment group below.
Therapeutic Response to Blue LED Photobiomodulation
PRIMARY OUTCOME Clinical improvement will be assessed based on the proportion of participants exhibiting complete resolution or a reduction in at least one vaginal sign or symptom present at the initial assessment, without worsening of any other assessed sign or symptom. Assessed clinical signs will include hyperemia, edema, leukorrhea, and fissures, classified as present or absent during the gynecological examination. Assessed symptoms will include pruritus, burning sensation, pain, vaginal dryness, and dyspareunia. Signs and symptoms will be evaluated upon the patient's entry into the study and immediately after the completion of all sessions. Additionally, follow-up assessments will take place 30, 60, and 90 days after the completion of therapy. Changes in each sign and symptom will be classified using a three-point Likert scale (improvement, unchanged, or worsening) relative to the baseline assessment.
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Patricia Lordelo
Lead sponsor
Centro de Atenção ao Assoalho Pélvico
Sponsor institution
Escola Bahiana de Medicina e Saude Publica
Collaborator
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