NCT04227392: ROSE

Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Completed NA Last updated 13 January 2020

What this trial tests

NA trial testing vaginal radiofrequency in Vaginal Laxity in 30 participants. Completed in 31 May 2019.

Timeline

1 July 2018

Primary endpoint
15 January 2019

31 May 2019

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 July 2018
Primary completion	15 January 2019
Estimated completion	31 May 2019
Sites	1 location across South Korea

Drugs / interventions tested

• vaginal radiofrequency

Conditions studied

• Vaginal Laxity — all drugs for Vaginal Laxity →

Sponsor

Seoul National University Hospital

Who can join

21 and older, female only, with Vaginal Laxity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.