Clinical trial NCT05557799: Photobiomodulation in Post Menopause Genitourinary Syndrome
Official title: Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postmenopausal Symptoms
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in the Female Sexual Function Index (FSFI)
timeFrame: Baseline and the 4 weeks of treatment.
Secondary outcomes:
measure: Changes in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: Baseline and the 4 weeks of treatment.
measure: Changes in the Vaginal Health Index Score
timeFrame: Baseline and the 4 weeks of treatment.
measure: Changes in the Vaginal pH
timeFrame: Baseline and the 4 weeks of treatment.
measure: Changes in Pain using a Visual Analog Scale (VAS)
timeFrame: Baseline and the 4 weeks of treatment.
measure: Changes in the Pelvic Floor Muscles (PFMs)
timeFrame: Baseline and once a week for 4 weeks
measure: Changes in Urinary Loss using Ped-Test
timeFrame: Baseline, the 4 weeks of treatment and 90 days after treatment.
measure: Changes in Vulva Temperature
timeFrame: Baseline and and once a week for 4 weeks
Other outcomes:
Locations:
Study officials:
References: