Photobiomodulation in Post Menopause Genitourinary Syndrome

NCT05557799 | Unknown Phase 1

• 1 other identifier: SGPM
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. METHOD: In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of PGS will be selected. Participants included in the study will be randomly divided into two groups: group A, which will receive photobiomodulation with a vaginal diode laser and its introit and group B (placebo) with the laser device turned off. Both treatments will be maintained for 4 consecutive weeks.The treatment group (n=30) will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for the 40s in each site, once per week for 4 weeks. The Placebo Group (n=30) will be handled as treated, but with the laser turned off. Quality of life will be analyzed using the female sexual functioning index (FSFI-6), the urinary incontinence questionnaire (ICIQ-SF), the intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI) and compared between groups. Also, the vaginal temperature will be measured using a thermal camera, as well as the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. The data will be tested for normality using the Shapiro Wilks test and, if they present a parametric distribution, they will be represented by means of their respective means and standard deviations.

Conditions

Postmenopausal Symptoms

Outcome Measures

Primary Outcomes (1)

• Changes in the Female Sexual Function Index (FSFI)

  The FSFI or female sexual function index is a specific and multidimensional questionnaire to assess female sexual response, accessing 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain evaluated in 19 questions about sexual activity in the last 4 weeks. In order to obtain the total score of the scale, the scores for each domain are added up, and for higher scores, better sexual function is considered, and the threshold for sexual dysfunction is a score of 2678. Based on the value of the total score, it would be possible discriminate between populations at higher and lower risk of experiencing sexual dysfunction.

  Baseline and the 4 weeks of treatment.

Secondary Outcomes (7)

• Changes in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

  Baseline and the 4 weeks of treatment.

• Changes in the Vaginal Health Index Score

  Baseline and the 4 weeks of treatment.

• Changes in the Vaginal pH

  Baseline and the 4 weeks of treatment.

• Changes in Pain using a Visual Analog Scale (VAS)

  Baseline and the 4 weeks of treatment.

• Changes in the Pelvic Floor Muscles (PFMs)

  Baseline and once a week for 4 weeks

Study Arms (2)

Photobiomodulation group

ACTIVE COMPARATOR

Participants in this group will receive photobiomodulation with a vaginal diode laser and its introit.

Radiation: Photobiomodulation

Placebo group

PLACEBO COMPARATOR

Participants in this group will receive simulated photobiomodulation, with the laser device turned off.

Radiation: Placebo Photobiomodulation

Interventions

Photobiomodulation RADIATION

The treatment group will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for 40s in each site, once per week for 4 weeks.

Photobiomodulation group

Placebo Photobiomodulation RADIATION

The Placebo Group will receive the same four consecutive applications, but with the laser turned off.

Placebo group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved);
• With one or more symptoms of UGS (dyspareunia, dryness, irritation and vaginal burning and/or discomfort, vaginal atrophy, vaginal and vulvar dryness, dysuria, frequency, recurrent urinary infections);
• With complaints of stress and/or urge urinary incontinence;
• Who have cervical cytopathology (Pap smear) within the normal range performed in the last year and are not in use of hormonal medication to treat menopausal symptoms in the last 6 months.

You may not qualify if:

• Participants with explicit refusal of the patient to participate in the researc;
• History of bilateral oophorectomy and diseases such as: recent AMI (Acute Myocardial Infarction), neoplasms, history of thrombosis, liver failure, uncontrolled genital bleeding, genital condylomatosis, active genital herpes, lower genital tract surgeries that make treatment impossible.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• Pereira SRDS, Mesquita-Ferrari RA, Salviatto LTC, Bezerra CDDS, Dalapria V, Mello EDS, Almeida-Lopes L, Bossini PS, Goncalves MLL, Deana AM. Photobiomodulation in post menopause genitourinary syndrome-Study protocol for a randomized, double-blind, controlled clinical protocol. PLoS One. 2024 Dec 2;19(12):e0313324. doi: 10.1371/journal.pone.0313324. eCollection 2024.

  PMID: 39621728 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither the participant nor the outcome assessor will know to which group the participant belongs, seeing as laser application will be simulated in the placebo group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: October 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09