Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT03630406
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.as Measured by Vaginal Tactile Imaging.
Status:
COMPLETED
Status Verified Date:
2020-09
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:
None
Brief Summary:
Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after Carbon Dioxide laser treatment.
Detailed Description:
Patients will be recruited and sign a consent form. The patients included are patients with SUI or vaginal wall weakness and prolapse. Each participant undergoes 3 laser treatments 4 weeks apart.
Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
* Before the first treatment session (baseline).
* Before and after each treatment session.
* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.
Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
* Before the first treatment session (baseline).
* Before and after each treatment session.
* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.
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?: