Clinical trial NCT06726746: Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy
Official title: Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Menopausal Vaginal Atrophy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Vulvovaginal Symptoms Questionnaire (VVSQ)
timeFrame: 4-6 months
measure: The Vaginal Health Index VHI assessment.
timeFrame: 4-6 months
Secondary outcomes:
measure: Urogenital Distress Short Form (UDI-6
timeFrame: 4-6 months
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: 4-6 months
measure: Female Sexual Function Index (FSFI)
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: