Back to resultsVaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.
Primary Purpose
Stress Incontinence, Female
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vaginal tactile imager
Sponsored by
About this trial
This is an interventional diagnostic trial for Stress Incontinence, Female
Eligibility Criteria
Inclusion Criteria:
- Any woman undergoing USI repair.
Exclusion Criteria:
- Women with high grade pelvic floor prolapse.
Sites / Locations
- Rambam health care campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing USI repair
Arm Description
Outcomes
Primary Outcome Measures
Vaginal elasticity assessment
Vaginal elasticity as measured by the vaginal tactile imager
Secondary Outcome Measures
Full Information
NCT ID
NCT03301818
First Posted
September 29, 2017
Last Updated
July 24, 2020
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03301818
Brief Title
Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Incontinence, Female
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing USI repair
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vaginal tactile imager
Intervention Description
Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.
Primary Outcome Measure Information:
Title
Vaginal elasticity assessment
Description
Vaginal elasticity as measured by the vaginal tactile imager
Time Frame
up to 3 months from enrollment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any woman undergoing USI repair.
Exclusion Criteria:
Women with high grade pelvic floor prolapse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam healthcare campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.
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