The Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER) was born, in part, out of a desire for a large study in the field of surgical men’s health that could serve as an advocacy tool for men’s health needs. The outcomes of this large, prospective, multi-center, real-world study will demonstrate the treatment effectiveness and improvement in quality of life in this patient population.
The Centers for Medicare & Medicaid Services (CMS) and Medicare recently ceased coverage for vacuum erection devices. In the past few years, CMS, Medicare, and ultimately, Congress, have discussed cessation of coverage for penile implants. There is a federal mandate requiring insurance companies to cover breast implant reconstruction after breast cancer surgery. Erectile dysfunction (ED) is linked to depression and lower quality-of-life. Considering the known, negative quality-of-life side effects associated with ED, the loss of CMS/Medicare coverage for penile implants would have a significantly detrimental impact on those Medicare patients who suffer from it. In fact, so critical a public policy matter is this that the New York Times recently published an article by writer, Paula Span, entitled "Sex Never Dies, but a Medicare Option for Older Men Does" addressing this very concern [http://www.nytimes.com/2015/08/04/health/sex-never-dies-but-a-medicare-option-for-older-men-does.html?_r=0]. Large clinical series must document the etiology and clinical patterns that substantiate value-based assessments of urologic procedures such as penile implants. Critical analysis of a common urologic procedure that addresses a known medical disease, erectile dysfunction, will be mandatory for public policy decisions.
The PROPPER registry was initiated in June, 2011, with 14 sites initially agreeing to participate. Only sites with IRB approval are enrolling subjects and currently 11 sites are active. All sites maintain a goal of contributing at least 20 patients and no site contains more than 40% of the patient population. As of April 2, 2015, 1019 subjects had been implanted with the penile prosthetic in this study.
Preoperatively, physician investigators recorded baseline patient characteristics such as age, penile measurements, and primary etiology, as well as completing the International Index of Erectile Function-5 / Sexual Health Inventory for Men (IIEF-5/SHIM), SF-12 Health-related Quality of Life (HRQOL) Questionnaire, Erectile Hardness Questionnaire (EHS), American Urological Association – Symptom Index (AUA-SI), and UCLA-Prostate Cancer Index (UCLA-PCI) Questionnaire. Surgical techniques and types were also evaluated included. Subjects are to be followed up to five years.
Of the 1019 subjects, radical prostatectomy (RP) was the predominant etiology in 285 subjects (28%); while 733 subjects had a different etiology noted (1 subject had no etiology noted). Subjects with an etiology of RP had worsening sexual function as reported through the UCLA-PCI Sexual Function score at baseline (17.9±14.7 vs 23.8±17.1, p<0.001). Nine RP patients had climacturia at baseline, compared with only one of the non-RP subjects (p<0.001). Additionally, the duration of erectile dysfunction was shorter on average in subjects who had a radical prostatectomy compared to those with other etiologies (5.8 years vs 7.3 years) (see Table 1).
Subjects with an etiology of RP also had more urinary conditions reported. Of the 285 RP subjects, 54 (18.9%) had concomitant stress urinary incontinence (SUI), while only 8 (1.1%) non-RP subjects had concomitant SUI (p<0.001). Additionally, the UCLA-PCI Urinary Function score for RP subjects was 69.6±27.4, compared to 85.4±20.5 in non-RP subjects indicating worsening urinary function in RP subjects at baseline (see Table 1).
In addition to baseline characteristic differences, subjects who had radical prostatectomies as their primary etiology tended to have more complex penile prosthetic procedures. The length of procedure for RP subjects was longer than for all other subjects (50.2 ± 28.6 minutes vs 46.8±28.9 minutes), although this difference was not significant. Of the subjects receiving an AMS 700 (three piece device, n=280), 65.0% (182/280) received placement of the reservoir in the traditional retropubic space, versus 31.8% (89/280) with reservoir placement in a submuscular (ectopic) location (see Table 1).
|Table 1: Subject Characteristics|
|Etiology of ED: Radical Prostatectomy (n=285)||Etiology of ED: Other (n=733)||Significance|
|Erectile dysfunction duration (years)||5.8±4.0||7.3±4.8||<0.001|
|Climacturia||9 (3.2%)||1 (0.1%)||<0.001|
|UCLA-PCI Sexual Function score||17.9±14.7||23.8 ± 17.1||<0.001|
|Stress urinary incontinence||54 (18.9%)||8 (1.1%)||<0.001|
|UCLA-PCI Urinary Function score||69.6±27.4||85.4±20.5||<0.001|
|Procedure time (minutes)||50.2 ± 28.6||46.8±28.9||0.135|
Subject status at procedure
Same day discharge
AMS700 Reservoir Placement
Space of Retzius
We hope this first-of- its-kind, prospective, multi-center study will serve as a standard for future investigations into the role of penile prosthetics within the U.S. The current study reveals most patients in North America have radical prostatectomy as the most common, primary etiology of penile implant surgery. The authors strongly believe that IPP implantation should be viewed foremost as cancer reconstruction, similar to federally mandated coverage of breast implant reconstruction; thus, patient advocacy for coverage is paramount for this most common male cancer in North America.
Written by: Gerard D Henry
Reference: The Journal of urology 2015 Aug 17 [Epub ahead of print]
Gerard D Henry, Edward Karpman, William Brant, Brian Christine, Bryan T Kansas, Mohit Khera, Leroy Jones, Tobias Kohler, Nelson Bennett, Eugene Rhee, Elizabeth Eisenhart, Anthony J Bella
Regional Urology, Shreveport, LA, El Camino Urology Medical Group, Inc , Mountain View, CA , University of Utah, Division of Urology, Salt Lake City, UT , Urology Centers of Alabama, Birmingham, AL , Urology Team, Austin, TX , Baylor College of Medicine, Houston, TX , San Antonio Urology, San Antonio, TX , SIU School of Medicine, Springfield, IL , Lahey Hospital and Medical Center, Burlington, MA , Kaiser Permanente, San Diego, CA , Regional Urology, Shreveport, LA , Division of Urology, Department of Surgery, University of Ottawa, Canada