Clinical trial NCT04492176: A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair
Official title: A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair: A Non-randomized, Open, Inter-group and Self-controlled Trial Before and After Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Keywords: Vaginal atrophy
Vaginal relaxation
stress urinary incontinence
CO2 fractional laser
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. Laser therapy with small trauma and short repair time has attracted much attention.
2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.
3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells.

Detailed description: 1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. It should be noted that patients with vaginal constriction need anti-scar training for a long time after operation to prevent the effect of vaginal entrance narrowing and vaginal wall scar formation on the quality of life of patients during the repair period. Therefore, laser therapy with small trauma and short repair time has attracted much attention.
2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal Internal environment and bacterial flora, and then reduce the probability of gynecological infection.
3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells. Our center has also passed the clinical observation ethical review of CO2 lattice laser to improve female vaginal relaxation in 2016, and completed the clinical trial at the end of 2017. The data further confirm that CO2 lattice laser can improve vaginal relaxation and is significantly effective for stress urinary incontinence.

Eligibility criteria: Inclusion Criteria:

* Married women aged 25-75 with improvement needs;
* Agree to participate in the experiment and sign the informed consent.
* Female sexual dysfunction patients;
* No other external treatment was performed before treatment at the lesion site.
* VTI instrument was used for intravaginal pressure test to assess urinary incontinence and vaginal senility caused by chronic muscle dysfunction

Exclusion Criteria:

* Pregnant or lactating women;
* suffering from severe mental disorders, psychological disorders, personality disorders and major organ dysfunction;
* Patients with severe hematological diseases, Sjogren's syndrome, systemic and therapeutic site infections;
* Patients who took high doses of anticoagulants or hormones within one month;
* Laser allergy history, photosensitive reactor;
* Women with acute vaginitis or cervicitis;
* Pap smear positive patients;
* Female HIV (HIV), HPV (papillary virus), HSV (herpes simplex virus) positive patients;
* Use of antifungal drugs, vaginal administration, vaginal irrigation and female sprays in the past 30 days
* The condition of the visual field of laser surgery affected by ulceration and infection of the skin lesion
* Those who have undergone vaginal tightening surgery with other substances or means

Primary outcomes:
measure: female sexual function FSFI score（Female Sexual Function Index ）
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: urinary incontinence questionnaire short form assessment
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: VHIS score in vaginal environment
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: vaginal pressure VTI data detection
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: pelvic floor magnetic resonance MRI plain
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: scantransvaginal ultrasound
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: histopathological biopsy
timeFrame: Changes before and 1month after treatment
Secondary outcomes:
measure: patient satisfaction assessment
timeFrame: Changes from preoperative to 1 year after initial treatment
measure: VAS Pain Assessment(Immediately after Treatment)
timeFrame: 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dermatology Derpartment of Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang
role: PRINCIPAL_INVESTIGATOR
References: