Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032, China
NCT Number: NCT04492176
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.
Looking for future studies?
Notify Me25 year–75 year
Female
Interventional
Not applicable
Xi'an, Shaanxi, 710032, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
gradually withdrawn from inside to outside of vaginal.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
Time frame: 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
Time frame: Changes from preoperative to 1 year after initial treatment
Evaluate urinary incontinence questionnaire short form assessment
Time frame: 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
Time frame: Changes from preoperative to 1 year after initial treatment
Evaluate vaginal pressure by VTI data detection
Time frame: Changes from preoperative to 1 year after initial treatment
Measure tissue structures in the pelvis
Time frame: Changes from preoperative to 1 year after initial treatment
Measure the structures of the vagina
Time frame: Changes before and 1month after treatment
5 cases were randomly selected for histopathological biopsy
Time frame: Changes from preoperative to 1 year after initial treatment
Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied
Time frame: 3 months
VAS pain scoring criteria (0-10 points): 0 points: no pain; less than 3 points: mild pain, can tolerate; 4 points 1-6 points: patients with pain and affect sleep, can still tolerate; 7 points-10 points : The patient has increasing pain, and the pain is intolerable
Xijing Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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