A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
NCT ID: NCT05250466
Last Updated: 2024-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-07-07
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency group
AI Temperature-controlled Radiofrequency Technology
Radiofrequency technology
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
Electrical stimulation group
Electrical Stimulation
Electrical stimulation
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.
Interventions
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Radiofrequency technology
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
Electrical stimulation
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.
Eligibility Criteria
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Inclusion Criteria
2. 18 to 60 years old;
3. Agree to sign the informed consent;
Exclusion Criteria
2. Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;
3. Patients with cardiovascular disease;
4. People with hematological diseases;
5. Patients with hypertension and diabetes;
6. People with mental illness;
7. Pregnant and lactating women.
18 Years
60 Years
FEMALE
No
Sponsors
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Zhongnan Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuanzhen Zhang, Professor
Role: STUDY_CHAIR
Wuhan University
Locations
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Yuanzhen Zhang
Role: primary
Other Identifiers
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vulvar leukoplakia 2022
Identifier Type: -
Identifier Source: org_study_id
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