Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06503003

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Genitourinary Syndrome of Menopause

Age range

45 year–73 year

Sex eligibility

Female

Study type

Observational

Primary location

Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy

Cagliari, CA, 09042, Italy

Location status: Recruiting

Location contact

Stefano Angioni

CONTACT

[email protected]

+3907051093399

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leonardo® Diode laser

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Angioni

CONTACT

[email protected]

+3907051093399

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Acronym: GSMLASER

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.