Vaginal Laxity
Conditions
Brief summary
To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.
Interventions
DEVICEvaginal radiofrequency
2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* vaginal laxity score \>= 3 * negative pregnancy test within 2 months
Exclusion criteria
* genital anomaly * pelvic prolapse stage \>= stage 3 * active genital infection * vulvar pain or deformity * disease related to sexual behavior * current, chronic NSAIDs intake * fever * any acute illness * cognitive disorder * pacemaker insertion * metal implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of vaginal laxity score from baseline | baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session | subjective vaginal laxity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of FSFI score from baseline | baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session | female sexual function index, higher is better |
| change of FSDS score from baseline | baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session | female sexual distress scale, lower is better |
| change of vaginal pressure from baseline | baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session | vaginal pressure measured with manometer |
Countries
South Korea
Outcome results
None listed