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RECRUITING
NCT06726746
NA

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

Sponsor: Cairo University

View on ClinicalTrials.gov

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)

Key Details

Gender

FEMALE

Age Range

45 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-10-01

Completion Date

2025-03-01

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

DEVICE

Fractional 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