Validation of Transvaginal Tactile Imaging

A Clinical Validation Study With Transvaginal Tactile Imaging

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01491334

Acronym

VTI-03

Enrollment

158

Registered

2011-12-14

Start date

2011-12-31

Completion date

2013-11-30

Last updated

2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

POP, Pelvic Floor, Pelvic Organ Prolapse

Brief summary

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

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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.

Countries

United States

Outcome results