Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-09 @ 8:39 PM
Study NCT ID:
NCT03301818
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2017-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Urinary Stress Incontinence (USI) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging.
Status:
COMPLETED
Status Verified Date:
2020-07
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 USI will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the USI. Surgical repair will be performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O) repair.
Detailed Description:
Patients will be recruited and sign a consent form. The patients included are patients with USI that are candidates for a TVT-O repair.
Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
* The day of surgery before surgery.
* The day after surgery.
* 3 months post-operational. 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:
* The day of surgery before surgery.
* The day after surgery.
* 3 months post-operational. 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?: