Gisselle Zazueta-Damian, RA IV, is our Senior Research Associate and Project Manager, who has been a dedicated teammate and has supervised numerous PFDN trials including ABC, ESTEEM, CAPABLe, NOTABLe, SUPeR/eSUPeR, ASPIRe/eASPIRe, and MUSA/PRoMISe. In addition to her supervision in our trials, she is also our lead regulatory personnel for IRB communication and protocol submissions.

Linda Mackinnon, MPH, RA II, is our Lead Research Associate and has been part of our team for 13 years. Linda has also been involved with numerous PFDN trials and she currently directs our eSUPeR, eASPIRe and MUSA trials. Linda takes pride in her work and continues to ensure that our team carries out our PFDN study commitments.

Diana Banales, RA IV, recently relocated to our department to assist with our growing portfolio. She started in the fall of 2023 and has already made a huge impact at our clinic. Diana started her clinical research experience 6 years ago in the Rheumatology Department as an unblinded pharmacist. This is where she was exposed to clinical trials. Diana found them intriguing, which in turn lead to the beginning of her research career. Diana has been a Project Manager for multiple clinical trials within Kaiser Permanente, which include trials with Gastroenterology, Endocrinology, Cardiovascular and Infectious Diseases (COVID-19).

Diana considers herself a newbie to PFDN but has already taken the initiative of leading one of the networks upcoming trials, TULIP. Not being exposed to pelvic floor disorders prior to joining our team, she finds it fascinating learning about pelvic floor disorders and listening to all the ongoing studies, but most of all looks forward to contributing to new and upcoming studies.

Diana is amazed on how all investigators within the network work so closely and diligently to develop new clinical trials. She expects the contributions made by all involved to be successful, impacting women substantially, and envisions herself being part of PFDN for many years to come.

In her spare time, Diana loves to travel and enjoy the beach. Some of her favorite vacationing locations are the Caribbean Islands. Her most recent vacationing island, Jamaica! One Love!!

Vanessa DeLoera, RA II, also recently joined our department to assist with our growing portfolio this past fall. Vanessa began her career as a Medical Assistant and then furthered her education to obtain her phlebotomy license. She was provided the opportunity to join Kaiser’s Department of Research and Evaluation and assisted on a multi-center study for the Epidemiology Department and soon thereafter transitioned to Clinical Trials. This March will mark 10 years since she began her journey in Clinical Trials at Kaiser Permanente San Diego.

Vanessa has been exposed to a vast number of clinical trials - from OBGYN, Gastroenterology, Infectious Diseases, Endocrinology, Cardiovascular, and now Urogynecology. Her experience has motivated her to continue her education and thus she will be starting a vocational nursing program this spring. She is eager to begin contributing in the PFDN and finds it rewarding to be able to work beside a talented group of investigators.

Vanessa’s life revolves around her family – husband, two teenage children, and two small but mighty yorkies, Jordi and Lola. In her spare time, she enjoys hiking and dancing. She particularly enjoys dancing bachata and takes dance classes in various SD downtown venues. Oh La La!!

Heidi W. Brown, MD, became a member of our Urogynecology division and a scientist of dissemination and implementation for our Department of Research and Evaluation this past summer. As a former Fellow of our team, she has already contributed to many trials within the department.

Dr. Brown’s research focuses on improving access to effective solutions for pelvic floor disorders such as bladder and bowel incontinence and pelvic organ prolapse. She uses community engagement, user-centered design, and iterative testing to inform development, adaptation, implementation, and maintenance of interventions that improve quality of life.

Dr. Brown’s primary research focuses on how to support women to adopt these behavior changes and pursue additional treatments when necessary. She is also interested in developing and testing streamlined implementation strategies to build and maintain productive connections between primary care, specialty care, and community resources.

In her spare time, Dr. Brown enjoys spending time with her husband and 3 sons, dancing, hiking, music, and the beach! Surf's up!

Duke University Hospital has had the privilege of being part of the Pelvic Floor Disorders Network since 2007. We have led several prominent studies within the network with an incredible group of passionate and talented investigators, providers, researchers, and staff. We are so excited to contribute to the innovative and groundbreaking clinical trials that can only be accomplished by the kind of collaboration allowed by multisite network studies!

Dr. Anthony Visco is our Division Chief for Urogynecology and Reconstructive Pelvic Surgery. He received his MD from State University of New York Upstate Medical University and completed his residency in OB/Gyn at the University of Rochester. One of the longest standing members of the PFDN, he has been a clinical site PI of the network for 21 years. His involvement in the PFDN since 2001, just out of fellowship, has been one of the most influential academic experiences of his career. He fondly recalls his first meeting, sitting around the table surrounded by “giants” in the field. Their mentorship about recruitment, trial design, and research techniques laid the foundation for his own contributions. With their encouragement, he was able to confidently challenge conventional practice and the status quo.

During one Steering Committee meeting in his early days, there was a lively discussion regarding whether Botox bladder injections should be reserved for refractory overactive bladder or whether drug naïve patients should be included in a randomized trial they were designing. By respectfully challenging “conventional wisdom”, while also balancing patient safety and autonomy, they were able to design a bold and meaningful randomized trial.

Stephanie Yu is our lead Clinical Research Coordinator for the PFDN. She joined Duke in 2022 and manages eSUPeR, eASPIRe, and MUSA for the site. She is a competitive powerlifter and Brazilian jiu jitsu practitioner who became interested in urogynecology due to the prevalence of pelvic floor disorders among female strength athletes. She is passionate about women’s health and diversity in medical research and has met with members of Congress to advocate for policies supporting reproductive rights and Diversity, Equity, and Inclusion. She is excited to be a part of the network and hopes to contribute to positive advances in women’s health.

Dr. Nazema Siddiqui came to Duke in 2007, which is the same year Duke became a site within the PFDN. Her training and clinical practice have been enormously influenced by the PFDN. PFDN trials have always been the way that we test new surgeries, new treatments, and new innovations for women, while also ensuring that our patients are safely cared for under close monitoring.

Her first direct involvement in the PFDN was in 2008 through a writing group led by Dr. Linda Brubaker. She was the most junior person in this group and was quite intimidated! Yet, Dr. Brubaker and others were interested in whatever promoted the best science, and she soon found her voice. In 2022 she was thrilled to step into the role of site PI and continue the tradition of Duke’s involvement with the PFDN and commitment to high-quality clinical trials.

At many levels, we see that conditions that affect women are not prioritized in large-scale research. Yet, the PFDN has been one of the few bright spots and has shown us successful ways to do large-scale, impactful work that helps the lives of women. Over the last two decades PFDN studies have helped us optimize pelvic surgeries, understand the role of physical therapy, and learn more about how the microbiome may be implicated in pelvic health disorders.

Today, Dr. Siddiqui serves as Duke Urogynecology’s Associate Professor and Director of Research, Division of Urogynecology and Reconstructive Pelvic Surgery. She looks forward to expanding the reach into new scientific areas, broader populations of women, and cultivating the next group of surgeon-scientists who will carry the torch and conduct innovative research that helps the lives of women.

The University of Pennsylvania became a member of the Pelvic Floor Disorders Network (PFDN) in 2011, with Dr. Lily Arya serving as the site’s Principal Investigator (PI). Dr. Arya transitioned the role of PI to Dr. Heidi Harvie in 2021.

The Health System includes The Hospital of the University of Pennsylvania, the flagship hospital, Pennsylvania Hospital, Presbyterian Medical Center and several satellite Clinics, which allows us to draw a large and ethnically diverse patient population from the tri state area, Pennsylvania, New Jersey and Delaware.

Penn’s Urogynecology Research Team is comprised of 4 Urogynecologists, a Urologist, 3 Nurse Practitioners (Megan Carullo, Stephanie Haly, Diane Newman), 5 Research Coordinators (Zandra Kennedy (Project Manager), Shannah Ellis, Ngozi Ikpeama, Shyanne Hall and Alexis Singer). Shyanne and Alexis are the newest members of the team, both recent graduates of the University of Pennsylvania.

Although we may be a small team we have been described as “the little engine that could” with regard to our team’s contributions to Women’s Health Research.

Dr. Lily A. Arya, Chief, Division of Urogynecology and Pelvic Reconstructive Surgery, William Goodell, M.D. Professor of Obstetrics and Gynecology

Urogynecology as a specialty was “invented” just as Dr. Arya was completing her training. When she first met women with bladder issues and understood its impact on their lives, she knew this would be her chosen specialty. Dr. Arya has never looked back since. She was a Principal Investigator of the PFDN for 10 years and now serves as a co-investigator. What she enjoys most about the PFDN is talking with the patients who take part in our clinical trials. She is so impressed with their insightful questions and their desire to contribute to science. Many of their questions are helping us decide what studies to do and how to design these studies. Our patients’ participation is helping this generation of women and all the future generations to come.

Dr. Heidi S. Harvie, Director, Penn Urogynecology & Pelvic Reconstructive Surgery, Pennsylvania Hospital, Associate Professor of Obstetrics and Gynecology at the Pennsylvania Hospital

Dr. Harvie is the Principal Investigator at Penn for the current PFDN cycle and was previously the alternate PI. She has been involved in the PFDN since Penn became a site in 2011. What she finds so rewarding about being part of the PFDN is being able to work with such an amazing research team to design studies and conduct trials that make a difference in our patients lives. She is truly grateful for all the patients who choose to participate in our PFDN trials to improve the care for and the lives of other women. Dr. Harvie chose the field of Urogynecology because she loves helping the patient population of women with incontinence and prolapse improve their quality of life.

Dr. Uduak U. Andy, Chief of Gynecology at Penn Presbyterian Medical Center, Associate Professor of Obstetrics and Gynecology at the Hospital of the University of Pennsylvania

Dr. Uduak Andy is the alternate PI at Penn for the current PFDN cycle. She has been involved in the PFDN since she was a Urogyn fellow, and Penn became a PFDN site in 2011. She has had the privilege of working with and learning from some of the best and brightest research minds in pelvic floor disorders research. The most rewarding part of being a part of the PFDN is interacting with our amazing study participants. Dr. Andy is grateful for these women, many of whom participate in our trials to help answer some of the pressing questions in our field and ensure that we have the data to provide the best care for other women. She was drawn to the field of Urogynecology as it aligns with my personal life mission of helping women have the best quality of life possible. Conducting research through the PFDN ensures that she is doing that. As a mother of three young daughters, she is most proud that the research we conduct and the answers we discover may help provide the best care for future generations of women, including her girls!

Dr. Ariana L. Smith, Alan J. Wein II Professor of Urology, Chief of Urology Pennsylvania Hospital, Director of Urogynecology & Reconstructive Surgery, University of Pennsylvania Perelman School of Medicine

Dr. Ariana Smith is board certified in Urology and Female Pelvic Medicine and Reconstructive Surgery allowing her to care for women with a broad range of pelvic floor disorders and urinary complaints. Her research focuses on treatment of bothersome urinary symptoms and promotion of bladder health. The best part of her role in the PFDN is interacting with the amazing participants who volunteer for our studies. Dr. Smith’s patients have greatly enjoyed participating in the PFDN studies and take great pride in their contribution to science. She is incredibly proud of their unwavering dedication and selflessness in completing all their research visits. By sharing their time and experiences, they have contributed valuable insights that will significantly advance our understanding of pelvic floor disorders.

Shannah Ellis, Clinical Research Coordinator

Shannah Ellis joined the UPenn Urogynecology team in 2022, after graduating with a bachelor’s degree in Biobehavioral Health from Pennsylvania State University. During the past two years, she has been working with Dr. Uduak Andy on the “Move on Up Study,” an integrated exercise and bladder training intervention to reduce falls in older women with urinary incontinence. She looks forward to transitioning to working with the PFDN on the upcoming studies. Over the past couple of years, Shannah has had the opportunity to work closely with research participants, completing in-home visits, immersing herself within the community, and hearing first-hand about the obstacles that women with incontinence issues encounter. Her dedication to Urogynecology research stems from a desire to empower women with the knowledge of pelvic floor disorders, treatments, and potential prevention strategies. In her spare time, Shannah enjoys golf, reading, traveling, music, and spending time with friends and family. She is excited to contribute to the PFDN and making a lasting impact on women’s health outcomes!

RTI International is an independent nonprofit research institute dedicated to improving the human condition. RTI works in more than 75 countries and has offices on four continents, with headquarters in Research Triangle Park, North Carolina. RTI joined the PFDN as the data coordinating center (DCC) in 2011. The DCC works with the PFDN clinical sites to develop studies that help address critical issues in women’s urogynecological health. The DCC provides data collection tools and analyzes data from the studies so results can be published - ensuring the work done by the network reaches women with pelvic floor disorders and their providers.

Marie Gantz, PhD, Senior Fellow in Statistics, has served as the principal investigator of the PFDN data coordinating center since RTI was awarded the DCC in 2011. The DCC has worked with the clinical centers to launch nine clinical trials studying treatments for urinary incontinence, fecal incontinence, and pelvic organ prolapse. The treatments include pelvic floor muscle training, medications, devices, and surgeries. The results of these studies are published in medical journals, and for recent studies we have created videos that can be found on the website under Impactful Results.

Dr. Gantz has found it rewarding to be part of PFDN, because she gets to work with a great group of people – inside the DCC and across the network – to do meaningful research that helps women by finding better treatments for pelvic floor disorders.

Megan Carnes, PhD, serves as the Alternate Principal Investigator (PI). In this role she supports Dr. Gantz and the other team members in a variety of ways, especially with study design, biospecimen collection, and statistical analyses. Much of Dr. Carnes’s work focuses on translational and genomic studies. Translational research aims to bridge the gap between basic science and clinical practice. This is often done using genomics to study samples collected from urine, vaginal swabs, and the gut to look for biomarkers (a biological marker of a disease or response to treatment) of pelvic floor disorders.

Dr. Carnes finds the most rewarding part of the work on PFDN is the clinical impact. This means that the results of our research can make a difference in the lives of patients and their families, as well as the health care system.

Carolyn Huitema is the DCC Research Operations Manager and has been with the network since 2011, bringing extensive experience and dedication to her role. She collaborates with the clinical sites to implement meaningful clinical studies, by developing trainings, overseeing study operations, and helping to address challenges and establish best practices.

What Carolyn loves most about PFDN is the opportunity to collaborate with a network of passionate and dedicated researchers who share a common vision of advancing the science and practice of pelvic floor disorders. The PFDN’s research is not only exciting, but also meaningful and transformative for the lives of patients and providers.

Benjamin Carper serves as the DCC Statistical Operations Manager, specializing in harmonizing data monitoring and reporting for the network and coordinating the creation of public use datasets for completed PFDN studies. He also serves as a Senior Statistician developing and advising on the design and analysis of PFDN clinical trials. He has worked on the PFDN since 2015.

Ben loves knowing that the work of the PFDN is helping people improve their quality of life. Clean data, well-analyzed, can lead to valid and repeatable results that can influence medical practice. He also really loves working with such a diverse team of medical doctors and scientific professionals that show such dedication to helping people and wanting to move the field forward.

Tucker Brenizer leads the development of the PFDN research systems and helps improve operations using data insights. More specifically, Tucker works with a group of programmers, analysts, and data managers to find the most efficient and cost-effective ways to meet the PFDN’s systems and data management needs. The key to success in this goal is the regular feedback that is received from the PFDN coordinators and collaborators, for whom he is sincerely grateful

Tucker has been with the PFDN since 2021. He has genuinely enjoyed learning from the other members of the RTI Team and getting to know our many site collaborators.