Vulvar Lichen Sclerosus
Conditions
Brief summary
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.
Interventions
PROCEDURERadiofrequency 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
PROCEDUREElectrical 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.
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia; 2. 18 to 60 years old; 3. Agree to sign the informed consent;
Exclusion criteria
1. Patients with severe liver and kidney dysfunction; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy index | 6 month after treatment | Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 6 month after treatment | Percentage of recurrence of genital itching 6 months after treatment |
Countries
China
Contacts
Primary ContactYuanzhen Zhang, professor
Backup ContactKejia Wu, Doctor
Outcome results
None listed