Validation of Transvaginal Tactile Imaging

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

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-11-30

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.

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Detailed Description

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1. The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.
2. The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.
3. The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.
4. 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).

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Asymptomatic

Asymptomatic women presenting at various ages without prolapse condition.

No interventions assigned to this group

Symptomatic

Symptomatic women presenting with prolapse conditions with no prior surgeries and women presenting with surgery scheduled with or without prior surgery.

No interventions assigned to this group

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes