A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair

NCT04492176 | Completed DMC FDA Device

• 1 other identifier: XijingH-PF-20190718
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Vaginal Atrophy

Keywords

Vaginal atrophy; Vaginal relaxation; stress urinary incontinence; CO2 fractional laser

Outcome Measures

Primary Outcomes (7)

• female sexual function FSFI score（Female Sexual Function Index ）

  Questionnaire content involving sexual activity, intercourse, sexual stimulation, sexual desire or sexual interest, sexual excitement or sexual arousal, evaluation of female sexual function, questionnaire score ≤ 26.55 is considered female sexual dysfunction

  Changes from preoperative to 1 year after initial treatment

• urinary incontinence questionnaire short form assessment

  Evaluate urinary incontinence questionnaire short form assessment

  Changes from preoperative to 1 year after initial treatment

• VHIS score in vaginal environment

  Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness

  Changes from preoperative to 1 year after initial treatment

• vaginal pressure VTI data detection

  Evaluate vaginal pressure by VTI data detection

  Changes from preoperative to 1 year after initial treatment

• pelvic floor magnetic resonance MRI plain

  Measure tissue structures in the pelvis

  Changes from preoperative to 1 year after initial treatment

• scantransvaginal ultrasound

  Measure the structures of the vagina

  Changes from preoperative to 1 year after initial treatment

• histopathological biopsy

  5 cases were randomly selected for histopathological biopsy

  Changes before and 1month after treatment

Secondary Outcomes (2)

• patient satisfaction assessment

  Changes from preoperative to 1 year after initial treatment

• VAS Pain Assessment(Immediately after Treatment)

  3 months

Study Arms (2)

CO2 fractional laser（ACUPULSE,Lumenis）

EXPERIMENTAL

gradually withdrawn from inside to outside of vaginal. with CO2 fractional laser therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%，ACUPULSE,Lumenis) ,once a month for a total of 3 times .CO2 fractional laser 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.

Device: CO2 fractional laser（ACUPULSE,Lumenis）

before treatment

NO INTERVENTION

the patient did not receive laser treatment

Interventions

CO2 fractional laser（ACUPULSE,Lumenis） DEVICE

gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times

CO2 fractional laser（ACUPULSE,Lumenis）

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gang Wang

  Dermatology Derpartment of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of dermatology

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: July 30, 2020
• Study Start: August 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

CN (1)