Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Seoul National University Hospital1 site in 1 country30 target enrollmentJuly 1, 2018

ConditionsVaginal Laxity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vaginal Laxity
Sponsor: Seoul National University Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: change of vaginal laxity score from baseline
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2018

End Date

May 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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
•any acute illness
•cognitive disorder
•pacemaker insertion
•metal implants

Outcomes

Primary Outcomes

change of vaginal laxity score from baseline

Time Frame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session

subjective vaginal laxity

Secondary Outcomes

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)
change of FSFI score from baseline(baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session)
change of FSDS score from baseline(baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session)