Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Vaginal Laxity Clinical Trial

— ROSE  

Official title:

Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227392
• Other study ID #: E-1801-444-001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Laxity

Intervention

Device:
• vaginal radiofrequency
2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam Si	Gyenggi DO

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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