Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-25 @ 2:02 PM
Study NCT ID:
NCT04227392
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2020-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROSE
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: