Vaginal Tactile Imaging for Pelvic Floor Prolapse

Artann Laboratories

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Other: Pre/post imaging

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT02925585

SB1AG034714 (U.S. NIH Grant/Contract)

VTI09

Details and patient eligibility

About

The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.

Enrollment: 119 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is female of 21 years or older, and
2. No prior pelvic floor surgery, and
3. One of the following:

Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment

Exclusion criteria

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
7. Severe hemorrhoids;
8. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
9. Current pregnancy.

Trial design

119 participants in 1 patient group

Pre/post pelvic floor surgery imaging

Treatment:

Other: Pre/post imaging