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

Seoul National University

Status: Completed

Conditions: Vaginal Laxity

Treatments: Device: vaginal radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT04227392

E-1801-444-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental

Experimental group

Description:

women who undergo radiofrequency therapy

Treatment:

Device: vaginal radiofrequency