Validation of Transvaginal Tactile Imaging

Study Overview
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Brief Summary
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The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.

Detailed Description
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The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1. The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery. The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3. The device will detect significant differences in tissue elasticity among 3 control groups with normal pelvic floor conditions (nulliparous women at age 21-30, parous women at age 31-40, and postmenopausal women).

Official Title
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A Clinical Validation Study With Transvaginal Tactile Imaging

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING No evidence of pelvic organ prolapse and no prior pelvic surgery Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled Exclusion Criteria: Active skin infection or ulceration within the vagina Presence of a vaginal septum; Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder; Ongoing radiation therapy for pelvic cancer; Impacted stool Recent (less than three months) pelvic surgery; Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia; Severe hemorrhoids Surgically absent rectum or bladder Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic<br>Asymptomatic women presenting at various ages without prolapse condition. | |
| Symptomatic<br>Symptomatic women presenting with prolapse conditions with no prior surgeries and women presenting with surgery scheduled with or without prior surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in assessment of the pelvic floor tissue conditions. |  | Two years. | 
| Ability in early detection of prolapse conditions. |  | One Year | 
| Ability in characterization of the outcome of pelvic floor reconstructive surgery. |  | Two years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POP, Pelvic Floor, Pelvic Organ Prolapse