Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial (ROSE)

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Laxity
• Intervention / Treatment: Device: vaginal radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyenggi DO
    • Seongnam Si, Gyenggi DO, Korea, Republic of, 463707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; women who undergo radiofrequency therapy	Device: vaginal radiofrequency; 2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of vaginal laxity score from baseline	subjective vaginal laxity	baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of FSFI score from baseline	female sexual function index, higher is better	baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
change of FSDS score from baseline	female sexual distress scale, lower is better	baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
change of vaginal pressure from baseline	vaginal pressure measured with manometer	baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: January 1, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: E-1801-444-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No