Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Artann Laboratories

Status: Completed

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT02294383

VTI05

R44AG034714 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.

Enrollment: 138 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No prior pelvic floor surgery, and
• 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

• 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;
• Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
• Severe hemorrhoids;
• Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
• Current pregnancy.

Trial design

138 participants in 4 patient groups

Pre/post surgery pelvic floor assessment

Conservative treatmen monitoring

Pelvic floor muscle contrictions

Imaging reproducibility