The UNITED Clinical Study evaluating the Rigicon Infla10® Dynamic Inflatable Penile Prosthesis (DIPP) is expanding with the addition of investigators from the University of South Florida and Tampa General Hospital, including Dr. Rafael Carrion.
Dr. Rafael Carrion has been appointed Principal Investigator for the USF/TGH study site, with Dr. Justin Parker and Dr. Raul Fernández-Crespo joining as Sub-Investigators.
Their addition expands the multicenter clinical investigation already involving prosthetic urologic surgeon, Dr. Paul Perito. For patients and surgeons alike, the expansion represents another important step in building the clinical evidence required to evaluate a new generation of penile prosthesis technology.
What Is the UNITED Clinical Study?
The UNITED Clinical Study is a prospective, multicenter, single-arm performance-goal study designed to evaluate the safety and effectiveness of the Rigicon Infla10® Dynamic Inflatable Penile Prosthesis.
The study is being conducted under an FDA-approved Investigational Device Exemption (IDE); this permits an investigational medical device to be studied in human participants so researchers can collect the safety and effectiveness data necessary for regulatory evaluation.
The UNITED Study is also classified as a CMS Category B IDE study. This designation allows Medicare and Medicare Advantage coverage of certain routine costs and qualifying investigational-device-related expenses for eligible study participants, subject to applicable coverage requirements.
The Infla10® Dynamic Inflatable Penile Prosthesis
Inflatable penile prostheses are established surgical treatments for men with erectile dysfunction who do not achieve satisfactory results with less invasive therapies, such as medication. The Infla10® Dynamic Inflatable Penile Prosthesis represents a newer device platform being evaluated through the UNITED Study.
Clinical studies such as UNITED are especially important in prosthetic urology; new devices must be evaluated on outcomes including:
- Device safety
- Mechanical reliability
- Surgical performance
- Complication rates
- Patient outcomes
- Effectiveness in restoring erectile function
- Longer-term device performance
The involvement of multiple centers and experienced prosthetic surgeons allows investigators to evaluate the device across a broader patient population and a range of clinical environments.
Dr. Paul Perito’s Role in the UNITED Study
Dr. Paul Perito is one of the investigators participating in the UNITED Clinical Study.
Dr. Perito has performed thousands of penile implant procedures and has spent decades refining minimally invasive techniques for inflatable penile prosthesis placement. His work in prosthetic urology includes the development and standardization of the minimally invasive infrapubic approach used in the Perito Implant™ Technique, as well as extensive surgeon education and clinical research.
Participation in the UNITED Study continues his focus on evaluating advances in penile implant technology through structured clinical investigation. For surgeons, experience with a new prosthesis provides an opportunity to assess how device design interacts with surgical technique. For patients, formal clinical research provides something even more important: evidence.
USF and Tampa General Hospital Join the Study
The newest UNITED Study site will be led by Dr. Rafael Carrion, a professor and specialist in sexual medicine, men’s health, Peyronie’s disease, and urology at the University of South Florida.
Dr. Carrion has contributed extensively to academic urology, with more than 100 peer-reviewed publications, more than 100 scientific abstracts, and numerous live surgical workshops, often performed in tandem with Dr. Perito.
Dr. Justin Parker and Dr. Raul Fernández-Crespo will participate as Sub-Investigators at the USF/Tampa General Hospital site. The addition of another major academic center broadens both the geographic reach and clinical depth of the UNITED Study.
Why Multicenter Research Matters
The importance of innovation in penile implant surgery for improving patient outcomes is two-fold.
In surgical innovation, improvements in operative technique, incision placement, instrumentation, infection prevention, recovery protocols, and postoperative management all contribute to the safety and efficacy of the placement of penile prostheses.
In device innovation, refinements in implant materials, cylinders, pumps, reservoirs, coatings, mechanical systems, and overall prosthesis design improve patient outcomes and reduce the risks of complications and add to the long-term longevity of prostheses.
As dedicated implanters and urologic surgeons, Dr. Perito and his colleagues have a specific goal: to judge new prostheses through clinical outcomes and reproducible evidence.
A multicenter study makes that evidence more meaningful by evaluating a device across different surgeons, institutions, and patient populations instead of relying on the experience of a single practice or investigator.
Advancing the Evidence Behind Penile Implant Surgery
Penile prosthesis technology has evolved considerably over the past several decades, often through innovations from the research, surgical training, and implementation of Dr. Perito and Perito Urology.
The expansion of the UNITED Clinical Study brings additional academic and surgical expertise into the evaluation of the Infla10® Dynamic Inflatable Penile Prosthesis and strengthens the body of evidence being developed around the device.