Photobiomodulation in Post Menopause Genitourinary Syndrome

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Postmenopausal Symptoms

Clinical Trial Details

NCT number	NCT05557799
Study type	Interventional
Source	University of Nove de Julho
Contact
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	October 30, 2022
Completion date	July 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT01170195` - Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms	Phase 1/Phase 2
Completed	`NCT00535288` - Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)	Phase 3
Recruiting	`NCT06030388` - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women	N/A
Recruiting	`NCT04893226` - Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women	N/A
Completed	`NCT03684096` - Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes	N/A
Completed	`NCT01268046` - Aging and Estrogen on Cortical Function	Phase 1/Phase 2
Recruiting	`NCT05659693` - The Effect of Digital Literacy Education Given to Postmenopausal Women on Health Literacy and Quality of Life	N/A
Completed	`NCT03572153` - A Mind-Body Intervention for Hot Flash Management	N/A
Not yet recruiting	`NCT06197568` - Open-Label Study of Vaginal AZU-101 in Postmenopausal Women	Phase 1/Phase 2
Withdrawn	`NCT03854396` - Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women	Phase 3
Completed	`NCT01361308` - Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)	Phase 3
Unknown status	`NCT00905723` - The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women	Phase 3
Recruiting	`NCT05351476` - Exercise Training and Fat Metabolism in Postmenopausal Women	N/A
Completed	`NCT06096818` - Kegel and Abdominal Exercises on Urinary Incontinence Severity, Quality of Life, and Sleep Quality in Menopausal Women	N/A
Completed	`NCT03150407` - Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness	N/A
Recruiting	`NCT04129060` - Cholinergic Health After Menopause (CHAMP)	Early Phase 1
Recruiting	`NCT04493333` - Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors	Phase 2
Completed	`NCT03786809` - Vascular Effect of CIMICIFUGA RACEMOSA	N/A
Not yet recruiting	`NCT05922800` - Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes	N/A
Completed	`NCT04286451` - Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity	N/A