Actively Recruiting

Age: 45Years - 73Years
FEMALE
ID06503003

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

Led by University of Cagliari · Updated on 2024-07-16

50

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how non-ablative dual-wavelength diode laser therapy affects Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who either cannot use or have not benefited from local estrogen therapies. It focuses on whether this laser treatment can improve symptoms such as vaginal dryness, burning sensation, and pain during intercourse, while also assessing its impact on vaginal health and sexual function. The study is observational and seeks to fill a treatment gap for women needing non-hormonal options. Participants will receive three monthly sessions of laser therapy using the Leonardoae Diode laser with wavelengths of 980 nm and 1470 nm. Each session lasts about 20 minutes and delivers 8 pulses per centimeter along the vaginal canal, with local lidocaine gel applied for anesthesia. The study includes evaluations before treatment, and follow-ups at three and six months after the last session. During the study, participants will complete self-assessments of GSM symptoms and questionnaires about sexual function and quality of life at each follow-up. Researchers will measure changes in vaginal dryness, burning sensation, pain during intercourse, vaginal health index, sexual function, and quality of life compared to baseline. The total participation involves treatment and follow-up visits over approximately six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 73Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Post-menopausal women aged 45-73 years
  • Sexually active
  • Experiencing physiological amenorrhea for more than 12 months
  • Having 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
Not Eligible

You will not qualify if you...

  • Untreated uterine or vulvovaginal cancers
  • Having a 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) infection
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 months

Participants receive three monthly sessions of non-ablative dual-wavelength diode laser therapy for Genitourinary Syndrome of Menopause. Each session lasts about 20 minutes and uses local lidocaine gel as an anesthetic.

3 visits (in-person, monthly sessions)

Long-term Monitoring

Duration - 6 months

Participants are evaluated at baseline, 3 months, and 6 months after the final laser treatment to assess changes in symptoms and quality of life.

3 visits (including baseline, 3 months, and 6 months post-treatment)

Trial Site Locations

Total: 1 location

1

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

Cagliari, CA, Italy, 09042

Actively Recruiting

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Research Team

S

Stefano Angioni

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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https://pubmed.ncbi.nlm.nih.gov/31990089

A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors.

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