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

DESCRIPTION provided by applicant 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 recommended by The American College of Obstetricians and Gynecologists ACOG since it is associated with less morbidity quicker recovery and lower costs than abdominal hysterectomy Furthermore Residents do not receive adequate training in vaginal surgical techniques to treat urinary or fecal incontinence and pelvic organ prolapse 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 damaged 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 The Miya Model has already demonstrated Content Validity There is no commercially available simulator that can train vaginal surgical skills as well as basic gynecological procedures to a breadth of health professionals as the Miya Model This Phase I SBIR has five Specific Aims that if achieved will further the validation of the Miya Model and develop a mass production design The first aim of this project will be to produce the replaceable vagina and uterus cartridges necessary to complete a Construct Validation study of performing a VH on the Model A second Specific Aim will be to develop a production design that can be mass produced at affordable prices to diverse medical training programs The third specific aim is to complete the Construct Validation study and demonstrate that those expert surgeons do show performance metrics that are significantly better than novice surgeons performing a VH on the Miya Model The fourth specific aim is to develop a curriculum for training residents in VH that incorporates simulation training on the Miya Model The final specific aim will be to modify the production design developed in the second Specific Aim based on data gathered on the Construct Validation study In Phase II the tooling necessary for mass production will be produced the curriculum will be expanded to include other vaginal surgery techniques and further validation studies will be completed The Miya Model will be used in OB GYN residency programs to train vaginal surgery techniques It will also be used numerous residency programs as well as a diverse group of nursing and allied health training programs for basic gynecology training It will also be used by hospitals for credentialing and medical device companies for product development and training PUBLIC HEALTH RELEVANCE Miya Model Advanced Gynecological Training Simulator Narrative OB GYN Residents do not receive adequate training in vaginal surgery techniques to competently perform a vaginal hysterectomy the hysterectomy technique recommended by The American College of Obstetricians and Gynecologists ACOG since it is associated with less morbidity quicker recovery and lower costs than abdominal hysterectomy Neither is OB GYN Residents sufficiently trained in vaginal procedures to treat urinary incontinence fecal incontinence or pelvic prolapse The simulator being developed in this NIH SBIR research and development program will give OB GYN residents the opportunity to be properly trained I vaginal surgery techniques that will have a profound impact on healthcare for women as well as to help control medical costs