Photobiomodulation in Post Menopause Genitourinary Syndrome

September 27, 2022 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Photobiomodulation group
Participants in this group will receive photobiomodulation with a vaginal diode laser and its introit.
Radiation: 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.
Placebo Comparator: Placebo group
Participants in this group will receive simulated photobiomodulation, with the laser device turned off.
Radiation: Placebo Photobiomodulation
The Placebo Group will receive the same four consecutive applications, but with the laser turned off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the Female Sexual Function Index (FSFI)
Time Frame: Baseline and the 4 weeks of treatment.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time Frame: Baseline and the 4 weeks of treatment.
This questionnaire has a score from zero to 21 points, with zero indicating the absence of symptoms and the greater the sum of the points, the greater the impact and severity of urinary incontinence (UI) symptoms. The maximum sum of the response values indicates a score of 21 points, referring to a high impact of UI on the individual's life.
Baseline and the 4 weeks of treatment.
Changes in the Vaginal Health Index Score
Time Frame: Baseline and the 4 weeks of treatment.
It consists of a clinical analysis during the speculum examination of 5 parameters: elasticity, pH, mucosal appearance, humidity and the presence of vaginal secretion. Each aspect evaluated receives a score, which varies from 1 to 5. The score may vary from 5 to 25, and a diagnosis of Vulvo Vaginal Atrophy (VVA) is considered when the values are less than or equal to 15, the maximum score of 25 points means absence of clinical signs of vulvovaginal atrophy. This assessment will be performed by a qualified professional during the physical examination.
Baseline and the 4 weeks of treatment.
Changes in the Vaginal pH
Time Frame: Baseline and the 4 weeks of treatment.
The evaluation of the vaginal pH will be carried out through a pH indicator strip, which when inserted in the middle third of the vagina in contact with the mucosa, has the color of the strip changed. Measurement of the vaginal cul-de-sac is avoided, because contact with mucus, blood or semen can alter the reading. The nitrazine tape must remain in contact with the vaginal wall for 5 seconds for later checking the pH on the colorimetric scale provided by the manufacturer. Normal vaginal pH is acidic, during menacme, it should be maintained between 3.8 and 4.5.
Baseline and the 4 weeks of treatment.
Changes in Pain using a Visual Analog Scale (VAS)
Time Frame: Baseline and the 4 weeks of treatment.
A VAS will be used to evaluate the vaginal complaints of the participants. They will receive a figure of a ruler with marks from 0 to 10, whose one end indicates complete absence of symptoms and the other indicates the worst possible symptom. For analysis of the Visual and Analog Scale of Symptoms of Genitourinary Syndrome (GUS) (VAS - SGU), the sum of one to twelve points will classify the symptoms from mild to severe.
Baseline and the 4 weeks of treatment.
Changes in the Pelvic Floor Muscles (PFMs)
Time Frame: Baseline and once a week for 4 weeks
The pressure sensor (dynamometer) will be introduced into the vaginal canal, and the resting vaginal pressure (resting muscles) will be quantified. The device will be calibrated, zeroed and it will be asked for the participant to contract their PFMs inwards and upwards as hard as possible 3 times and maintain the contraction for at least five seconds (maximum vaginal pressure), with an interval of 30 seconds between each pull.
Baseline and once a week for 4 weeks
Changes in Urinary Loss using Ped-Test
Time Frame: Baseline, the 4 weeks of treatment and 90 days after treatment.
The procedure for performing the Ped-test will be as follows: initially, the participant will be asked to place an absorbent with a previously measured weight close to the external urethral meatus. Then, she will be given a 500 mL bottle of water to drink and wait for 15 minutes. Afterwards, the participant will be asked to perform some actions simulating activities of daily living. After carrying out the proposed activities, the absorbent will be removed and weighed on a precision scale, with a minimum reading of 0.1 mg and a maximum capacity of 220 g. Urinary losses are evaluated and classified as follows: losses of up to 1 g are considered insignificant; between 1.1 and 9.9 g are classified as light losses; between 10 and 49.9 g are moderate losses; and above 50 g, severe losses.
Baseline, the 4 weeks of treatment and 90 days after treatment.
Changes in Vulva Temperature
Time Frame: Baseline and and once a week for 4 weeks
The temperature of the vulva, in Celsius degrees, will be evaluated at the eight points of radiation in the vulvar region, with a digital infrared thermometer, which will allow measurement without physical contact. The average of the eight readings will be calculated before and after the diode laser procedure in the 4 consecutive weekly sessions.
Baseline and and once a week for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGPM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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