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临床试验/NCT04492176
NCT04492176已完成不适用

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

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
VHIS score in vaginal environment
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 75 Years（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

VHIS score in vaginal environment

时间窗: Changes from preoperative to 1 year after initial treatment

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

vaginal pressure VTI data detection

时间窗: Changes from preoperative to 1 year after initial treatment

Evaluate vaginal pressure by VTI data detection

histopathological biopsy

时间窗: Changes before and 1month after treatment

5 cases were randomly selected for histopathological biopsy

urinary incontinence questionnaire short form assessment

时间窗: Changes from preoperative to 1 year after initial treatment

Evaluate urinary incontinence questionnaire short form assessment

female sexual function FSFI score（Female Sexual Function Index ）

时间窗: Changes from preoperative to 1 year after initial treatment

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

pelvic floor magnetic resonance MRI plain

时间窗: Changes from preoperative to 1 year after initial treatment

Measure tissue structures in the pelvis

scantransvaginal ultrasound

时间窗: Changes from preoperative to 1 year after initial treatment

Measure the structures of the vagina

次要结局

  • patient satisfaction assessment(Changes from preoperative to 1 year after initial treatment)
  • VAS Pain Assessment(Immediately after Treatment)(3 months)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gang Wang, MD

chief of dermatology

Xijing Hospital

研究点 (1)

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