Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
- Conditions
- Vaginosis, Bacterial
- Interventions
- Device: Blue Light Emitting Diode (LED) 401 +/- 5nm
- Registration Number
- NCT03500107
- Lead Sponsor
- Centro de Atenção ao Assoalho Pélvico
- Brief Summary
Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.
- Detailed Description
A current treatment proposal is the use of blue LED of 401 +/- 5 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxygen and it causes cells death with no possibilities of resistance by the bacterium.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
• women with 18 to 65 years old and with diagnosis of bacterial vaginosis
• women with injury seen by Pap smear, or in use of pacemaker, with diagnosis or suspicion of neoplasias, with heart diseases, pregnant or with diagnosis of epilepsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Blue LED 401 +/- 5 nm Blue Light Emitting Diode (LED) 401 +/- 5nm The Blue LED 401 +/- 5 nm will be applied in the participant, in a closed room by a physiotherapist for 1 hour. The apparatus will be supported on a tripod, statically, externally, 5 cm away from the vulva abd vaginal region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol consists of only one session. This part of the study will see if there is bactericidal effect of the blue LED.
- Primary Outcome Measures
Name Time Method Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm 15 days This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms
Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED 15 days This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED
Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm 10 minutes This exam will be done by the collect of vaginal secretion using KOH 10%
Value of vaginal pH measurement in women treated by blue LED 2 minutes This exam will be done by the collect of vaginal secretion using a pH measuring tape to analyse the hydrogen potential in -log 10 \[pH+\] in women treated by blue LED. It will be used the numeric scale of pH value
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública
🇧🇷Salvador, Bahia, Brazil