Validation of Transvaginal Tactile Imaging (VTI-03)

Artann Laboratories

Status: Completed

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01491334

VTI-03

1R43AG034714 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 158 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

158 participants in 2 patient groups

Asymptomatic

Description:

Asymptomatic women presenting at various ages without prolapse condition.

Symptomatic

Description:

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