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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-07-20

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.

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Laparoscopic POP repair

Patients undergoing laparoscopic surgery for the repair of pelvic organ prolapse.

vaginal tactile imager

Group Type EXPERIMENTAL

vaginal tactile imager

Intervention Type DEVICE

Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.

Vaginal POP repair

Patients undergoing vaginal surgery for the repair of pelvic organ prolapse. vaginal tactile imager

Group Type EXPERIMENTAL

vaginal tactile imager

Intervention Type DEVICE

Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.

Interventions

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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.

Intervention Type DEVICE