A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia

Study Overview
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Brief Summary
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The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 260 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 130 cases in the radio frequency observation group and 130 cases in the electric stimulation control group.

Official Title
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A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia

Conditions
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Vulvar Lichen Sclerosus

Intervention / Treatment
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* Procedure: Radiofrequency technology
* Procedure: Electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia; 18 to 60 years old; Agree to sign the informed consent; Exclusion Criteria: Patients with severe liver and kidney dysfunction; Combined with HIV, syphilis infection, acute vaginitis, cervical cancer; Patients with cardiovascular disease; People with hematological diseases; Patients with hypertension and diabetes; People with mental illness; Pregnant and lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency group<br>AI Temperature-controlled Radiofrequency Technology | Procedure: Radiofrequency technology<br>* The vulva and vagina were routinely disinfected with iodophor, the negative plate was placed on the patient's waist and abdomen, and the vulva module was selected for treatment for 10 minutes per side, for a total of 20 minutes. Parameters: power 10-20W, temperature 38-42C°, once every 10 days, 5 times in total<br>|
| Active Comparator: Electrical stimulation group<br>Electrical Stimulation | Procedure: Electrical stimulation<br>* Routine vulvovaginal disinfection with iodophor, vaginal probes are placed in channel A, electrode pads are placed in channels B\C\D respectively, the frequency of electrical stimulation (the most comfortable amount) is adjusted, 10 times is a course of treatment, and mild lesions are treated for 1-2 courses of treatment , 2 to 3 courses of treatment for moderate to severe lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy index | Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100% | 6 month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Percentage of recurrence of genital itching 6 months after treatment | 6 month after treatment |