Photobiomodulation in Post Menopause Genitourinary Syndrome

NCT ID: NCT05557799

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2023-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Photobiomodulation group

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

Group Type: ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo Photobiomodulation

Intervention Type: RADIATION

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

Interventions

Photobiomodulation

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.

Intervention Type: RADIATION

Placebo Photobiomodulation

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 39621728 (View on PubMed)

Other Identifiers

SGPM

Identifier Type: -

Identifier Source: org_study_id