Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Not Applicable

Completed

• Conditions: Vaginal Laxity
• Interventions: Device: vaginal radiofrequency

• Registration Number: NCT04227392
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-05-31
• Status Verified: 2019-12
• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-09
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	vaginal radiofrequency	women who undergo radiofrequency therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam Si, Gyenggi DO, Korea, Republic of