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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 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency group | Experimental | AI Temperature-controlled Radiofrequency Technology |
|
| Electrical stimulation group | Active Comparator | Electrical Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency technology | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy index | Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100% | 6 month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Percentage of recurrence of genital itching 6 months after treatment | 6 month after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanzhen Zhang, professor | Contact | +86 13545364853 | wdzn2019@163.com | |
| Kejia Wu, Doctor | Contact | +86 13545364853 | wdzn2019@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuanzhen Zhang, Professor | Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
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| Electrical stimulation | Procedure | 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. |
|
| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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