ClinicalTrialsFinder
RecruitingNot ApplicableNCT06726746

Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy

Sponsor

Cairo University

Enrollment

20 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Post Menopausal Vaginal Atrophy

Summary

Vaginal dryness, itching, burning, irritability, secretion, and various urinary problems are the symptoms of vulvovaginal atrophy. Therefore, more attention must be paid to relieve these symptoms in order to provide better sexual health for postmenopausal women. At present, an accumulating body of evidence suggests safety and efficacy of laser and energy-based devices for the treatment of women's genitourinary conditions. More clinical studies are needed to assess the safety profile and clinical outcomes of the lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy (VVA)

Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 65 Years

Inclusion Criteria3

  • Menopausal women whose ages ranged from 45 to 65 years.
  • Sexually active
  • Had symptoms of VVA (vaginal dryness, irritation, soreness, or dyspareunia)

Exclusion Criteria8

  • Any history of hormonal therapy within the past 6 months
  • Vaginal moisturizer or lubricant applications within the past 30 days
  • Acute/recurrent urinary tract infection
  • Active genital infection
  • Prolapse stage II or more based on examination
  • Psychiatric disorders
  • Undiagnosed vaginal bleeding
  • Any serious disease or chronic condition that could interfere with study compliance
Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEFractional CO2 laser

. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus. The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic.

Locations(1)

Cairo University

Cairo, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06726746