Development and Validation of the Miya Model Sling Simulator, A Simulator Designed to Train Gynecologic Sling Surgery Techniques

Miyazaki Enterprises, Llc, Winston-Salem NC

Investigators

Abstract

Miya Model Sling Simulator: Abstract OB/GYN Residents must develop numerous skills including pelvic exams, child birth, open surgery, laparoscopic surgery, and vaginal surgery. Studies demonstrate that OB/GYN Residents lack training in vaginal surgical techniques, including Vaginal Hysterectomy (VH), the desired hysterectomy technique, and placing midurethral slings for Urinary Incontinence (UI). Meeting the need for physicians trained in proper placement of slings for is a public health concern as the rate of UI is expected to grow rapidly with the aging population. The Miya Model is a complete female pelvic anatomy model created to simulate actual surgical experiences including lifelike skin and life-sized organs, realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system with bleeding for inadequate technique, and an inflatable bladder that can leak water if damaged. The model is modular in that all of the parts are designed as cartridges that are easily replaceable when utilized in a simulated surgery. The anatomical correctness of the model can be used to train a broad range of health professionals on general procedures like bimanual exam, speculum and pap smear, as well as advanced gynecologic vaginal surgeries. There is no commercially available simulator that has the potential to train multiple vaginal surgical skills, including VH and midurethral slings, other than the Miya Model. The Miya Model has already demonstrated Content and Construct Validity for VH. This Phase I SBIR has five Specific Aims that if achieved, will add validated midurethral sling training to the Miya Model. The first Specific Aim is to design and produce disposable vaginal cartridges for midurethral sling placement that are economical to use and required for a Construct Validation study. Our second Specific Aim is to develop a scoring paradigm for midurethral sling placement that will show a high degree of inter-rater reliability when evaluating trainees on the Miya Model or live patients. Our third Specific Aim will use the vaginal cartridges of Specific Aim 1 and the scoring system of Specific Aim 2, to demonstrate that the Miya Model has construct Validity and can distinguish between novice and expert sling surgeons. The fourth Specific Aim is to evaluate the metrics and scoring paradigm developed in Specific Aim 2 and used in the Construct Validation study of Specific Aim 3 to determine if any modifications are necessary to ensure a high degree of inter-rater reliability. The final specific aim will be to modify the production design of the vaginal cartridges, developed in the first Specific Aim, based on data gathered on the Construct Validation study. In Phase II, a multi-center Concurrent Validation study will be completed to demonstrate that training for midurethral slings on the Miya Model is superior to traditional training and the tooling for mass production will be produced. When completed, the Miya Model will be used by numerous medical residency programs, not only OB/GYN, as well as a diverse group of nursing and allied health training programs. It will also be used by hospitals for credentialing and medical device companies for product development and training.