Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact (GSMLASER)

July 13, 2024 updated by: Stefano Angioni, University of Cagliari

The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are:

Does non-ablative dual-wavelength diode laser therapy improve vaginal dryness, burning sensation, and dyspareunia in post-menopausal women? What is the impact of this therapy on the vaginal health index and sexual function? Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM.

Participants will:

Undergo three monthly sessions of dual-wavelength diode laser therapy. Participate in follow-up evaluations at three and six months post-treatment. Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up.

This study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM, addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • CA
      • Cagliari, CA, Italy, 09042
        • Recruiting
        • Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of post-menopausal women aged 45-73 years who are experiencing symptoms of Genitourinary Syndrome of Menopause (GSM). These women are sexually active and have experienced physiological amenorrhea for more than 12 months. The participants have not used lubricants or hormonal therapy in the previous six months. The study targets those who cannot use or have not benefited from local estrogen-based therapies.

Description

Inclusion Criteria:

  • Post-menopausal women aged 45-73 years.
  • Sexually active.
  • Experiencing physiological amenorrhea for more than 12 months.
  • Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).
  • Not using lubricants or hormonal therapy in the previous 6 months.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Untreated uterine or vulvovaginal cancers.
  • Pacemaker or other implanted electrode carriers.
  • Severe multi-organ or neurological diseases.
  • Active sexually transmitted infections.
  • Moderate to severe uterine prolapse.
  • Active urinary tract infections.
  • Acute or chronic dermatological conditions in the vulvar or vaginal area.
  • Active genital herpes.
  • Active high-risk Human Papillomavirus (HPV).
  • Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.
  • Recent unhealed invasive or ablative surgeries.
  • Bleeding disorders or anticoagulant therapy.
  • Immunodeficiencies.
  • Uncontrolled diabetes.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laser Therapy Group
Participants will receive non-ablative dual-wavelength diode laser therapy for Genitourinary Syndrome of Menopause (GSM). The intervention includes three monthly sessions using the Leonardo® Diode laser (Biolitec®) with wavelengths of 980 nm and 1470 nm. Each session lasts about 20 minutes and involves 8 pulses per centimeter along the vaginal canal. Local lidocaine gel is used as an anesthetic. Evaluations occur at baseline, 3 months, and 6 months post-treatment.
Device: Leonardo® Diode laser
The intervention involves non-ablative dual-wavelength diode laser therapy for treating Genitourinary Syndrome of Menopause (GSM). This includes three monthly sessions of the Leonardo® Diode laser (Biolitec®), with wavelengths of 980 nm and 1470 nm, delivering 8 pulses per centimeter along the vaginal canal, using local lidocaine gel as an anesthetic. Evaluations are conducted at baseline, 3 months, and 6 months post-treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vaginal Dryness
Time Frame: Baseline, 3 months, 6 months after the final laser treatment
Measurement of the change in vaginal dryness scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse vaginal dryness.
Baseline, 3 months, 6 months after the final laser treatment
Change in Burning Sensation
Time Frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in burning sensation scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse burning sensation.
Baseline, 3 months, and 6 months after the final laser treatment
Change in Pain During Intercourse (Dyspareunia)
Time Frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in pain during intercourse scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse pain during intercourse.
Baseline, 3 months, and 6 months after the final laser treatment
Change in Vaginal Health Index Score (VHIS)
Time Frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in the Vaginal Health Index Score (VHIS), which examines five aspects of vaginal health: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each component is rated on a scale from 1 (indicating severe vaginal atrophy) to 5 (indicating no clinical signs of vaginal atrophy), with a total score below 15 confirming vaginal atrophy. Higher scores indicate better vaginal health.
Baseline, 3 months, and 6 months after the final laser treatment
Change in Sexual Function
Time Frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in sexual function scores using the Female Sexual Function Index-6 (FSFI-6). The FSFI-6 is a six-item version of the Female Sexual Function Index-19 (FSFI-19) and includes one item from each original domain: desire, arousal, lubrication, orgasm, satisfaction, and pain. Responses range from 0 (no sexual activity) to 5 (optimal function), with higher scores indicating better sexual function. An FSFI-6 score of 19.0 or less indicates sexual dysfunction.
Baseline, 3 months, and 6 months after the final laser treatment
Change in Sexual Quality of Life
Time Frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in scores on the Sexual Quality of Life-Female (SQOL-F) questionnaire. The SQOL-F questionnaire consists of 18 items that assess sexual self-esteem, emotional well-being, and relationship issues. Scores range from 18 to 108, with higher scores indicating better sexual quality of life.
Baseline, 3 months, and 6 months after the final laser treatment
Change in Sexual Function
Time Frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in sexual function scores using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The PISQ-12 is a 12-item questionnaire used to evaluate sexual function in patients suffering from urinary incontinence or pelvic organ prolapse. It explores three domains: behavioral-emotive, physical, and partner-related, scored on a 5-point Likert scale from 0 (always) to 4 (never), with reverse scoring for the first four items. Higher scores indicate better sexual function.
Baseline, 3 months, and 6 months after the final laser treatment

Collaborators and Investigators

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

Sponsor

University of Cagliari

Investigators

  • Principal Investigator: Stefano Angioni, University of Cagliari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 13, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP/2022/4057

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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