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

NCT ID: NCT06726746

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-03-01

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)

Detailed Description

This is a prospective, investigational study that will be performed in private outpatient clinic on 30 participants.

All participants will be scheduled for four visits (V1, V2, V3, and V4) with a 4- week interval where they will receive the interventions in the first three visits (V1, V2, and V3), While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.

Detailed medical history of all participants will be collected including age, age at menopause, parity, type of delivery, history of vaginal reconstructive surgery, history of hormonal treatment, and sexual activity status.

At each visit (V1, V2, V3, and V4), the participants will be interviewed to assess Vaginal Health Index using the VHI score and assess the changes in the Female Sexual Function Index FSFI.

Signs of vaginal atrophy will be evaluated during pelvic examination After pelvic examination and completion of the questionnaire, the interventions will be performed.

The participants will receive the interventions in the first three visits (V1, V2, and V3).While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.

The Procedures will be performed in private outpatient clinic. The participants will receive the intervention by using the CO2 laser machine. 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.

Participants will be advised to avoid sexual intercourse or intravaginal devices for at least 3 days after the procedure owing to transient local inflammation at the vaginal mucosa generated by the laser application.

Conditions

Post Menopausal Vaginal Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention by using the 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.

Group Type: EXPERIMENTAL

Fractional CO2 laser

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Menopausal women whose ages ranged from 45 to 65 years.

2. Sexually active

3. Had symptoms of VVA (vaginal dryness, irritation, soreness, or dyspareunia)

Exclusion Criteria

1. Any history of hormonal therapy within the past 6 months

2. Vaginal moisturizer or lubricant applications within the past 30 days

3. Acute/recurrent urinary tract infection

4. Active genital infection

5. Prolapse stage II or more based on examination

6. Psychiatric disorders

7. Undiagnosed vaginal bleeding

8. Any serious disease or chronic condition that could interfere with study compliance

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Onsi Anis

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Daniel Onsi

Role: CONTACT

Phone: +201272755335

Email: daniel.onsi@ngu.edu.eg

Mohammed El-Noury

Role: CONTACT

Phone: +201222146848

Email: Amr_elnoury@yahoo.com

Facility Contacts

Amr El-Noury

Role: primary

Other Identifiers

1000

Identifier Type: -

Identifier Source: org_study_id