Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency
Primary Purpose
Pelvic Organ Prolapse
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 Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- Any woman undergoing POP repair
Exclusion Criteria:
- Women above or below the age limit
Sites / Locations
- Rambam health care campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Laparoscopic POP repair
Vaginal POP repair
Arm Description
Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse. vaginal tactile imager
Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager
Outcomes
Primary Outcome Measures
Vaginal elasticity assessment
Vaginal elasticity as measured by the vaginal tactile imager measuring the local vaginal pressure (in mmHg)
Secondary Outcome Measures
Comparison of vaginal elasticity between repair methods
Assessment of the difference in vaginal elasticity (measured in mmHg) between the laparoscopic and vaginal surgical repair groups.
Full Information
NCT ID
NCT03311685
First Posted
September 29, 2017
Last Updated
July 24, 2020
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03311685
Brief Title
Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency
Official Title
Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Pelvic Organ Prolapse (POP) 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 POP will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the POP. Surgical repair will be performed by a single surgeon who will perform either a laparoscopic or vaginal repair.
Detailed Description
Patients will be recruited and sign a consent form. The patients included are patients with POP that are candidates for either laparoscopic or vaginal 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
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic POP repair
Arm Type
Experimental
Arm Description
Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse.
vaginal tactile imager
Arm Title
Vaginal POP repair
Arm Type
Experimental
Arm Description
Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager
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 surgery in a 3 month interval.
Primary Outcome Measure Information:
Title
Vaginal elasticity assessment
Description
Vaginal elasticity as measured by the vaginal tactile imager measuring the local vaginal pressure (in mmHg)
Time Frame
Up to 3 months from enrollment
Secondary Outcome Measure Information:
Title
Comparison of vaginal elasticity between repair methods
Description
Assessment of the difference in vaginal elasticity (measured in mmHg) between the laparoscopic and vaginal surgical repair groups.
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 POP repair
Exclusion Criteria:
Women above or below the age limit
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 Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency
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