Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginal Laxity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

women who undergo radiofrequency therapy

Group Type EXPERIMENTAL

vaginal radiofrequency

Intervention Type DEVICE

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

Interventions

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vaginal radiofrequency

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes