Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: vaginal tactile imager

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Any woman undergoing POP repair

Exclusion Criteria:

• Women above or below the age limit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laparoscopic POP repair; Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse. vaginal tactile imager	Device: vaginal tactile imager; Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.
EXPERIMENTAL: Vaginal POP repair; Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager	Device: vaginal tactile imager; Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal elasticity assessment	Vaginal elasticity as measured by the vaginal tactile imager measuring the local vaginal pressure (in mmHg)	Up to 3 months from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months from enrollment

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): July 20, 2020

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (ACTUAL): October 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 0295-17-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No