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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04227392

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Laxity	Device: vaginal radiofrequency	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Jan 15, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam Si	Gyenggi DO	Korea, Republic of	463707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04227392

Other Study ID Numbers:

E-1801-444-001

First Posted:

Jan 13, 2020

Last Update Posted:

Jan 13, 2020

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 13, 2020