Validation of Transvaginal Tactile Imaging

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

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