The research activities of the fellows are an integral part of their educational experience. It is expected that fellows will enter the program with an interest in research, with varying backgrounds and levels of previous experience with research. In the first year of the fellowship, didactic conferences provide the framework necessary for the fellows to develop into independent researchers. Dr. Barber organizes the conferences, with invited lectures from staff in the Department of Quantitative Health Sciences and Bioethics. The lectures cover the basic elements of epidemiology, clinical research design, data analysis and interpretation. Additionally, Center for Female Pelvic Medicine and Reconstructive Surgery holds monthly research meetings that include faculty from the Departments of Ob/GYN, Urology, Colorectal Surgery, and Quantitative Health Sciences where potential collaborative research projects are developed and on-going research projects are discussed. Within this structure, fellows learn how to proceed from identifying a research question to developing a research protocol.
Fellows are expected to initiate and complete their own independent research. At the beginning of the fellowship, each fellow meets with the Program Director to explore areas of interest. Once specific topics are chosen, with guidance from a designated faculty member and using resources both within and outside the department, the fellow works through the steps of formulating a specific research question, determining the most appropriate study design, and developing the research protocol including plans for data collection and analysis. The proposed project is presented for critical review to a committee composed the Program Director, the fellow’s Faculty research mentor and other interested faculty. As appropriate, the protocol is reviewed and approved by the Institutional Review Board at the Cleveland Clinic. Personnel support such as research nurses are provided; additional funding, if necessary, is available by application to the institution’s Research Programs Committee or through outside funding sources. It is anticipated that the fellows will gain experience in writing grant proposals for Federal and non-Federal research funding.
Obviously, the choice of study design varies by the nature of the research question. Clinical research projects can be performed either retrospectively or prospectively. There is a wealth of clinical material available for retrospective study at our institution. Senior members of the Department of Obstetrics and Gynecology have been performing between 500 and 600 surgical cases per year related to prolapse and incontinence for approximately the past 20 years. Inpatient and outpatient Cleveland Clinic records are maintained in EPIC (Electronic Patient Information Chart). Records are computerized by diagnosis and surgical procedure, which allows for easy identification of study groups.
The fellows are strongly encouraged to develop prospective trials in gynecologic surgery, especially related to urinary and fecal incontinence, pelvic organ prolapse, and other pelvic floor diseases. Potential subjects for prospective studies are available through the practice of all faculty members in the Department of Obstetrics and Gynecology, and other departments, as appropriate. Funding for projects may be available through the CCF Research Program Council, as well as through the Minimally Invasive Surgery Center. Research nursing support is available for the identification,
recruitment, enrollment and tracking of subjects in prospective studies. Data management is facilitated with the use of computerized databases.
The fellows also have an opportunity to perform basic science research in several laboratories within the Pelvic Floor Center. Dr. Margot Damaser in the Department of Biomedical Engineering has an active laboratory focusing on the biomechanics and neuromuscular control of the lower urinary tract and female pelvic floor, particularly with regard to injuries incurred during childbirth. Over fifteen investigators including post-doctoral fellows, graduate students in biomechanical engineering, FPMRS fellows and urology residents perform research in one of the three laboratory facilities supervised by Dr. Damaser. Ongoing research include developing and using animal models of stress urinary incontinence and fecal incontinence to determine the mechanisms of injury that occur in vaginal delivery and devise methods of treating and/or preventing development of SUI and FI. Methods under investigation include facilitation of innate stem cell homing to the pelvic floor organs and tissues; hormonal supplementation; or use of neuroregenerative agents. A second major focus of study for this lab is the characterization of genetic mouse model of pelvic organ prolapse (Loxl 1 knock-out mice) and investigating its potential for use in identifying those patients most at risk for pelvic floor disorders as well as in development of new treatments for female pelvic floor disorders. Additional research being performed in Dr. Damaser’s lab in which FPMRS fellows are or have been involved include the development of a functional virtual reality model of the female pelvic floor and investigations using animal models of fecal incontinence. Additionally, basic science laboratories in the Glickman Urological Institute are available to the fellows.
The Cleveland Clinic Center for Surgical Innovation Technology and Education (cSITE), formerly the Minimally Invasive Surgery Center, supports both basic science and clinical research of new surgical innovations through research funding and houses an advanced basic science and clinical research facility available to fellows. Ongoing FPMRS fellow-initiated clinical projects funded by cSITE include a prospective randomized trial comparing conventional laparoscopic versus robotically-assisted sacral colpopexy for treatment of advanced pelvic organ prolapse and a prospective randomized trial of conventional laparoscopic versus robotically assisted laparoscopic hysterectomy for benign gynecologic disease. Both of these projects were designed by former FPMRS fellows and the fellows served as principal investigators of the project. The laboratory components of the cSITE research facilities include a state-of-the-art animal lab for survival studies and anatomic teaching/research lab. The vivarium is set up for large and small animal surgical studies. There is a support area for animal preparation and care from veterinary services. Two operating rooms are available for experimental studies, which range from new abdominal procedures to minimally invasive cardiac procedures. One operating room is set up with state-of-the-art endoscopic and telecommunication equipment. This experimental area is shared by Colorectal Surgery, Urology, and other specialties so that collaboration is facilitated. The anatomic teaching/research laboratory has two components: first, a lab for cadaver and animal work (wet lab) and second, a lab for simulation model training (dry lab). The wet lab facility is equipped with eight stations, full function OR tables, full anesthetic equipment and operating instruments to simulate a real operating room experience as well as fresh frozen cadaver storage facilities and a full-time dedicated support staff.
It is important that the fellows be totally exposed to the process and proceedings of large collaborative multicenter research trials and the process of NIH grants. In addition to initiating and completing their own independent research projects, fellows may also participate in multicenter research projects, research projects funded in other departments such as Urology, and through corporate grants. The Cleveland Clinic is a member of the NIH Pelvic Floor Disorders Network (PFDN) and fellows are encouraged to participate in PFDN protocols. This includes recruiting patients, administering treatments, and performing follow-up examinations. Additionally, data from the pelvic floor disorders network studies are available for secondary or ancillary analyses to all members of the PFDN clinical site. Through this organization, fellows may have the opportunity to work on multicenter trials and to gain exposure to national leaders in gynecologic surgery. It is also anticipated that the fellows will gain experience in writing grant proposals for Federal and non-Federal research funding.