Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial

NCT03500107 | Recruiting DMC

• 1 other identifier: Centro CAAP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginosis, Bacterial

Keywords

Blue Light Emitting Diode; Women

Outcome Measures

Primary Outcomes (4)

• Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm

  This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms

  15 days

• Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm

  This exam will be done by the collect of vaginal secretion using KOH 10%

  10 minutes

• Value of vaginal pH measurement in women treated by blue LED

  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

  2 minutes

• Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED

  This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED

  15 days

Study Arms (1)

Blue LED 401 +/- 5 nm

EXPERIMENTAL

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.

Device: Blue Light Emitting Diode (LED) 401 +/- 5nm

Interventions

Blue Light Emitting Diode (LED) 401 +/- 5nm DEVICE

The participant will be naked, in a gynecological stretcher and lithotomy position, and the apparatus of the LED will be positioned in front of the vulva and vaginal region, 5 cm away, it will be statically, externally, and supported on a tripod. The protocol will consist of only one session.

Also known as: Questionnaire of anamnesis

Blue LED 401 +/- 5 nm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with 18 to 65 years old and with diagnosis of bacterial vaginosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead
• University of Messina: collaborator
• Salvatore Giovanni Vitale M.D.: collaborator

Study Sites (1)

Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública

Salvador, Estado de Bahia, 40290000, Brazil

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia Lordelo

  Centro de Atenção ao Assoalho Pélvico

  STUDY DIRECTOR

Central Study Contacts

Patricia Lordelo

CONTACT

+55 71 3330 1640; pvslordelo@hotmail.com

Patricia Lordelo

CONTACT

+55 71 3276 8260; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: October 2, 2018
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)