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Completed

NCT Number: NCT04227392

Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

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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Key information

Conditions

Vaginal Laxity

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyenggi DO, 463707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal radiofrequency

Device

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

Primary outcomes

  1. change of vaginal laxity score from baseline

    Time frame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session

    subjective vaginal laxity

Secondary outcomes

  1. change of FSFI score from baseline

    Time frame: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session

    female sexual function index, higher is better

  2. change of FSDS score from baseline

    Time frame: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session

    female sexual distress scale, lower is better

  3. change of vaginal pressure from baseline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: ROSE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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