Postpartum Vaginal Laxity
Conditions
Interventions
Active Group:The subjects receive radiofrequency treatment with a radiofrequency hyperthermia device equipped with neutral electrodes, valva and vaginal electrodes tips once every three weeks for a to
Sham Group:The subjects receive sham treatment of a radiofrequency hyperthermia device equipped with neutral electrodes, valva and vaginal electrodes once every three weeks for a total of three times.
Sponsors
Air Force Medical Center, PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand and voluntarily sign the informed consent form 2. Premenopausal women =18 years old 3. At least one full-term vaginal delivery (>36 weeks of gestation) and =12 months from enrollment in this study 4. In the VLQ, the subject’s subjective subjective feeling of vaginal relaxation during sexual intercourse is "very loose", "loose" or "somewhat loose" and the vaginal relaxation measured by the researcher is "severe looseness" or "moderate looseness" or "mildly relaxed" 5. Cervical cytology results are normal 6. Willing to have vaginal intercourse at least once a week (Note: Except for subjects who need to avoid vaginal intercourse for at least 1 week after each study treatment) 7. Maintain a monogamous, heterosexual relationship for at least 6 months before screening in this study 8. Subjects have reasonable expectations and can understand and comply with research procedures and all visit schedules 9. Women of childbearing age agree to use contraception throughout the study period
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or planning to become pregnant during the study, or who have given birth in the past 12 months. Women of childbearing age, with a positive pregnancy test during the screening period or before treatment; or subjects who do not agree to effective contraception during the trial 2. Lactating women 3. Have a history of genital tract fistula, thin rectovaginal septum (approximately 1 cm or 1 finger width) as assessed by the researcher, or IV degree perineal tear 4. Pelvic organ prolapse outside the hymenal ring 5. Have an implanted pacemaker, any other implanted electromagnetic device or metal implant (except dental implants) 6. Suffering from acute or chronic vulvar diseases (pain (such as vulvitis, vulvar vestibulitis), vulvar sensory disorders or vulvar malnutrition, vulvar skin diseases (such as psoriasis, lichen planus, tinea cruris, lichen sclerosus, seborrheic dermatitis) , contact or irritant dermatitis, lichen simplex, eczema) or bullous dermatoses or systemic diseases involving the vulva (eg, scleroderma, systemic lupus erythematosus)) 7. Have a history of active irritable bowel syndrome or Crohn's disease 8. Have a history of keloids or hypertrophic scars 9. Have a history of cholinergic urticaria 10. Combined with dyspareunia or vaginismus that affects sexual activity 11. Subjects suffering from serious or progressive diseases. According to the judgment of the investigator, there are serious risks for the subject to participate in this clinical trial (such as cancer or precancerous lesions, uncontrolled diabetes, serious cardiovascular and cerebrovascular diseases). (eg, stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischemic heart disease, tachyarrhythmia, severe heart failure [NYHA Class III-IV], etc.) 12. Combined with active pulmonary tuberculosis or pulmonary insufficiency judged by the researcher (such as COPD, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis or bronchopulmonary dysplasia, etc.) 13. Have a history of epilepsy 14. Those who are judged by the researcher to have uncontrolled or unstable hypertension 15. Subjects who are judged by the researcher to have severe liver or kidney dysfunction 16. Positive results of HIV (Human Immunodeficiency Virus) antibody test, syphilis serology test, gonorrhea or chlamydia trachomatis test during the screening period, and/or gynecological examination confirmed active genital herpes, genital warts or chancroid 17. Inflammation or unhealed wounds on the vulva and/or inner vulva 18. The researcher determines that there is a history of mental illness (such as depression, anxiety, bipolar disorder) that may affect study compliance and evaluation. 19. Currently taking drugs that are known to affect sexual function (such as antihypertensive drugs, antipsychotics, chemotherapy drugs, PD5 inhibitors, etc.); unless the dose is stable for at least 1 month before study treatment and will not occur during the study There are anticipated changes in medication regimens. Women taking oral contraceptives before enrollment were allowed to continue taking them throughout the study 20. Long-term use (defined as a stable daily dose for at least 3 months before screening) of immunosuppressive or anti-inflammatory drugs (such as ibuprofen, aspirin, and steroids) that may affect collagen production/healing; unless the subject can Discontinue these medications at least 30 days before treatment Those who have received vaginal ti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FSFI, Female Sexual Function Index;VAS, Visual Analog Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| FSDS-R, Female Sexual Distress Scale-Revised;VLQ, Vaginal Laxity Questionnaire;SSQ, Sexual Satisfaction Questionnaire; | — |
Countries
China
Contacts
Public ContactHONG CAI
Air Force Medical Center, PLA
Outcome results
None listed