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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: vaginal tactile imager


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any woman undergoing POP repair Exclusion Criteria: Women above or below the age limit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |