Development Study Using Vaginal Tactile Imager

A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue

The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.

Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable examination procedure, collect data necessary for assessing the performance of Vaginal Tactile Imaging sensors, assess clinical suitability of interface software and correlate elasticity measurements with clinical examination findings for normal versus prolapse conditions of the female pelvis.

Inclusion Criteria:

1. no evidence of pelvic organ prolapse and no prior pelvic surgery
2. stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments
3. no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material)

Exclusion Criteria:

1. patients with active skin infection, tissue breakdown or ulceration
2. patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion
3. recent pelvic surgery with less than 3-month interval from surgery