New Registry Tracks Patient Outcomes From Penile Implant Surgery

The Duke Division of Urology recently launched the Prosthetics Registry and Outcomes in Urology at Duke (PROUD), enabling clinicians to assess postoperative patient satisfaction from penile implant surgery, research possible improvements to prosthetic devices, and collect data prospectively using a scientific rigor that has not previously been available. By analyzing the data from PROUD, Duke urologists are working to improve the overall quality of a procedure that can dramatically improve quality of life and reduce anxiety in men.

“PROUD gives us a great repository to track patient outcomes over time and allows us to be more scientific about collecting data, which has traditionally been one of the criticisms of reconstructive surgery for treating erectile dysfunction,” says Aaron Lentz, MD, associate professor of surgery and director of the Duke Urology Men’s Health Center. Lentz specializes in reconstructive urologic surgery and performs more than 120 penile prosthesis implantation surgeries each year.

The first step in designing PROUD was to develop a comprehensive, prospective database using Research Electronic Data Capture (REDCap; Vanderbilt University, Nashville, Tennessee), a secure web application for building and managing online surveys and databases, to include more than 200 unique variables that influence surgical approach and outcomes in prosthetic surgery. Duke Urology has more than 20 years of implantation experience compiled by a cadre of high-implanting surgeons, providing a unique perspective for studying any changes in the outcomes of patients who have received penile implants.

By capturing data in a prospective fashion, investigators can utilize new surveys with questions specifically validated for men who have undergone penile implant surgery. Historically, the surveys used to assess patient satisfaction with the procedure, such as the International Index of Erectile Function or the Erectile Dysfunction Inventory of Treatment Scale, were not validated specifically for this patient population and therefore did not provide the focused results that clinicians needed to thoroughly evaluate outcomes.

Patients complete the encrypted surveys at home, and data are automatically logged into the registry, making it easy for clinicians to perform statistical analyses with little effort on the part of patients. If modifications are made to the prosthetic devices used in implant surgery, or if a procedure is improved, patient outcomes can be assessed in real time to determine whether the modifications are beneficial. “This is a much more systematic method of improvement, rather than simply asking patients if things are going well or not,” Lentz notes. He adds that Duke Urology resident Evan Carlos, MD, was instrumental in helping to develop PROUD.

According to Lentz, industry data indicate that more than 1 million men in the United States are good candidates for penile implant surgery; however, only about 20,000 implants are performed annually. This illustrates a disconnect between patients and providers that he believes can begin to be addressed with the analysis now possible with PROUD. Although research is just beginning with data from PROUD, Lentz reports that initial findings indicate a high level of patient satisfaction—approximately 90% of survey participants who chose to have an implant said they would have the surgery again and would recommend it to a friend.

PROUD will also be used to help urologists manage common complications, such as urethral injuries, during penile prosthesis implantation. Lentz and colleagues recently presented their findings on this topic at the American Urological Association Annual Meeting in May 2017 and the Sexual Medicine Society of North America Annual Meeting in October 2017.

“Many specialists and primary care providers treat men with erectile dysfunction, but if standard treatments such as oral medications fail, providers need to know that there are other options that we’re finding to be very successful. Some men are hesitant to have an implant, but the most common reaction I hear from my patients postoperatively is: ‘I wish I’d done it years ago.’”

PROUD currently houses data on Duke patients only; however, Lentz anticipates that it will eventually be expanded to include patients treated in other high-volume medical centers around the United States, strengthening the statistical power of the data collected and allowing providers to use the data to help patients receive the best care in their own communities.