NCT04227392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

January 1, 2020

Last Update Submit

January 9, 2020

Conditions

Vaginal Laxity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • change of FSFI score from baseline

    baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session

  • change of FSDS score from baseline

    baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session

  • 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

Study Arms (1)

Experimental

EXPERIMENTAL

women who undergo radiofrequency therapy

Device: vaginal radiofrequency

Interventions

vaginal radiofrequencyDEVICE

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

Experimental

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • vaginal laxity score \>= 3
  • negative pregnancy test within 2 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyenggi DO, 463707, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2020

First Posted

January 13, 2020

Study Start

July 1, 2018

Primary Completion

January 15, 2019

Study Completion

May 31, 2019

Last Updated

January 13, 2020

Record last verified: 2019-12

Locations

KR(1)