Effect of Vaginal Radiofrequency Therapy on Vaginal Laxit... | NCT04227392

Studies
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial

NCT04227392

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 13, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Vaginal Laxity

Interventions

vaginal radiofrequency

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jan 15, 2019Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Jan 1, 2020

First Submission Date that Met QC Criteria

Jan 9, 2020

First Posted Date

Jan 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2020

Last Update Posted Date

Jan 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	women who undergo radiofrequency therapy	Device: vaginal radiofrequency

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal radiofrequency	Device	2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
change of FSDS score from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyenggi DO	463707	South Korea