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

NCT06726746 | Recruiting

• 1 other identifier: 1000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Post Menopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (2)

• The Vulvovaginal Symptoms Questionnaire (VVSQ)

  4-6 months

• The Vaginal Health Index VHI assessment.

  4-6 months

Secondary Outcomes (3)

• Urogenital Distress Short Form (UDI-6

  4-6 months

• Incontinence Impact Questionnaire Short Form (IIQ-7)

  4-6 months

• Female Sexual Function Index (FSFI)

  4-6 months

Study Arms (1)

intervention by using the Fractional CO2 laser

EXPERIMENTAL

. 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.

Device: Fractional CO2 laser

Interventions

Fractional CO2 laser DEVICE

. 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.

intervention by using the Fractional CO2 laser

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Central Study Contacts

Daniel Onsi

CONTACT

+201272755335; daniel.onsi@ngu.edu.eg

Mohammed El-Noury

CONTACT

+201222146848; Amr_elnoury@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

EG (1)