University Hospitals Urology Institute Awarded $9.2 Million by the Patient Centered Outcomes Research Institute

CLEVELAND -University Hospitalshas been approved for $9.2 millionin research funding by the Patient-Centered Outcomes Research Institute (PCORI). The study is led by David Sheyn, MD,division director of urogynecology and pelvic reconstructive surgery at University Hospitals Urology Institute, and aims to study bulking versus sling for treating urinary incontinence at the time of vaginal prolapse repair.

"We are very excited to undertake this tremendous work with 10 other centers across the United States, including with my co-principal investigator Dr. Cecile Ferrando at UC San Diego. This is the first ever randomized trial comparing these two treatment options for urinary incontinence at the time of pelvic organ prolapse repair and was entirely designed with input from patients, some of whom will also serve on our stakeholder advisory board that will ensure that the study prioritizes a patient centered approach. Urogynecology is a very patient-centered specialty, and we highly value their input when deciding on treatment options. We hope this study will also serve as a general framework for how others approach the study of pelvic floor disorders," said Dr. Sheyn.

Stress urinary incontinence (SUI) is a common condition that results in leakage of urine during any physical activity. Urinary incontinence may cause physical discomfort, poor self-image and difficulties with sex and may limit normal daily activities. SUI often happens at the same time as pelvic organ prolapse (POP), which is when a pelvic organ (the bladder, uterus or bowel) herniates into the vagina and causes an uncomfortable bulge in the vagina or problems with the bladder or bowel.

One of the most common treatments for both conditions is surgery. Several different kinds of procedures are used to treat SUI at the time of POP surgery, which is often performed through the vagina. Some of these are relatively new, meaning patients and surgeons do not have enough information to help guide them in selecting the best procedure.

The research team asked several patients who already underwent surgery for these conditions to identify the most important outcomes for them. Researchers used their answers to develop this study and determine the outcomes they need to measure.

This type of research is important because it does not just focus on the outcome of the surgery, but also on factors that are important to patients. There is not enough information yet to help guide patients and doctors in deciding the best SUI treatment option for each patient at the time of vaginal POP surgery.

This will be the first study to compare slings and Urethral bulking at the time of POP repair to determine how these two procedures affect both the short- and long-term patient quality of life, with outcomes developed using input specifically from patients who have already undergone both of these kinds of surgeries.

Surgery for SUI at the time of vaginal surgery for POP may be performed by using a sling made out of synthetic material called mesh.

• This procedure has been used for almost 25 years and has been proven to be both safe and effective.
• However, many patients have some concerns about using a synthetic material that will remain in their body indefinitely, as well as the fact that surgical mesh has been associated with surgical complications that may be difficult to treat.
• Because of this, there have been many efforts to develop procedures that do not use mesh slings.
• However, many of these procedures tend to be more invasive, often requiring a belly incision, and non-mesh procedures may have as many complications as the mesh sling.

Urethral bulking (UB), which involves injection of a gel underneath the lining of the urethra to narrow the urethral canal, is a procedure that is also very effective to treat SUI, but may not be quite as effective as a sling.

• UB might have fewer serious complications than slings, which appeals to patients.
• While doctors think the same is true for patients who would undergo UB at the time of vaginal surgery for POP, there have not been any well-designed research studies to prove this.
• There is also not enough information to tell if patients will accept a lower success rate for UB if they are already planning an invasive surgery for POP.
• It is not known how UB affects outcomes that are important to patients, including the effect of each type of SUI procedure on sexual function, other types of bladder symptoms such as difficulty emptying the bladder, and overactive bladder and quality of life in general.

Many clinical studies test under carefully controlled conditions in specialized research centers whether an approach to care works, but healthcare is rarely delivered in such optimized situations and settings. Pragmatic clinical studies, like this one, test a treatment's effectiveness in "real-world" clinical situations, such as standard hospitals and outpatient clinics. They can also include a wider range of study participants, making their findings more generally applicable.

This study was selected through PCORI's highly competitive review process in which patients, caregivers and other stakeholders join scientists to evaluate proposals.

"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders, but also for its conduct in real-world settings. It has the potential to answer an important question about treating urinary incontinence and fill a crucial evidence gap," said PCORI Executive Director Nakela L. Cook, MD, MPH. "We look forward to following the study's progress and working with University Hospitals Urology Institute to share its results."

"Dr. Sheyn's award for this work is a tremendous feat. His funding is the largest PCORI award in University Hospitals history, and we can't wait to bear witness to the research advances it brings to the field and our community," said Lee Ponsky, MD, FACS, Chairman, UH Urology Institute, the Leo & Charlotte Goldberg Chair in Advanced Surgical Therapies and Master Clinician in Urologic Oncology.

Dr. Sheyn'saward has been approved pending completion of PCORI's business and programmatic review and issuance of a formal award contract.

PCORIis an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health and health care decisions.

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