B. Kansas

The Who, How and What of Real-World Penile Implantation in 2015: The PROPPER Registry Baseline Data

PURPOSE To date, the published data on patients treated with penile implantation generally consist of small series of single surgeon, retrospective experiences rather than prospective or large, multicenter evaluations. This study establishes a baseline of data collection from the PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration). The PROPPER is the first large, prospective, multicenter, multinational, monitored, and internal review board approved study of real-world outcomes for patients with penile implants. MATERIALS AND METHODS Data from the PROPPER study were examined to determine patient baseline characteristics and primary and secondary etiologies before treatment of erectile dysfunction. Data include type and size of implant received, surgical steps/techniques used during implantation, and duration of hospital stay. RESULTS Through April 2, 2015 a total of 1,019 patients were enrolled in the study at 11 sites, with radical prostatectomy being the predominant etiology in 285 (28%). Of those 285 patients treated with radical prostatectomy 280 (98.2%) received an AMS 700™. Of these patients 65.0% (182 of 280) had placement of the reservoir in the traditional retropubic space vs 31.8% (89 of 280) in a submuscular location. Of those patients not treated with radical prostatectomy receiving an AMS 700, fewer underwent reservoir placement in the submuscular location (17.7%, 124 of 702, vs 80.9%, 568 of 702; p <0.001). Of those patients receiving an AMS 700, those treated with radical prostatectomy and those with diabetes had more outpatient admissions (less than 24 hours, 56.8% and 52.1%, respectively) compared to those with cardiovascular disease and Peyronies disease (42.0% and 35.6%, respectively, p <0.001). CONCLUSIONS This first-of-its-kind, large, prospective, multicenter study reveals most penile implant cases in North America receive an inflatable penile prosthesis and that radical prostatectomy is the most common primary etiology of penile implant surgery. Moreover, patients treated with radical prostatectomy were more likely to have the reservoir placed in a submuscular location, have a longer operating room time and be admitted to the hospital overnight compared with other patient groups.

Reservoir Alternate Surgical Implantation Technique: Preliminary Outcomes of Initial PROPPER Study of Low Profile or Spherical Reservoir Implantation in Submuscular Location or Traditional Prevesical Space

PURPOSE Alternative reservoir site placement has become an accepted technique for patients who require an inflatable penile prosthesis. To our knowledge there has been no prospective evaluation of this technique, which is currently off label. We performed a prospective, multicenter, multinational, internal review board approved study to evaluate the effectiveness and safety of alternative reservoir site placement. MATERIALS AND METHODS PROPPER initiated in June 2011, is a database containing patient outcomes of inflatable penile prosthesis implantation. Patients with AMS® penile prostheses continue to be enrolled at 13 North American sites. We examined PROPPER study data to determine surgical implantation use patterns for the AMS 700™ series. We evaluated reservoir implantation site and complications by implantation site. RESULTS A total of 759 patients had been implanted with an AMS 700 series implant by the time of evaluation. Mean patient followup was 17.8 months (range 0 to 36). There was no reported case of revision surgery for a palpable reservoir and no report of vascular or hollow viscous injury associated with alternative reservoir site placement. Two cases of reservoir herniation in the alternative reservoir site placement group and 2 in the space of Retzius group were treated with reservoir reimplantation. Patients with 1-year assessment available were satisfied or very satisfied with the device and reported a frequency of use of more than once per month. CONCLUSIONS Alternative reservoir placement in the submuscular location is an option in patients who undergo inflatable penile prosthesis surgery. Implant surgeons should consider alternative reservoir site placement a safe, effective alternative to reservoir placement in the space of Retzius.

Inflatable penile prosthesis implant length with baseline characteristic correlations: Preliminary analysis of the PROPPER study

Background “Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration” (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data points for the first time in the literature and postulate that radical prostatectomy (RP) is negatively correlated with penile corporal length. Methods Patient demographics, medical history, baseline characteristics and surgical details were compiled prospectively. Pearson correlation coefficient was generated for the correlation between demographic, etiology of ED, duration of ED, co-morbid conditions, pre-operative penile length (flaccid and stretched) and length of implanted penile prosthesis. Multivariate analysis was performed to define predictors of implanted prosthesis length. Results From June 2011 to June 2017, 1,135 men underwent primary implantation of penile prosthesis at a total of 11 study sites. Malleable (Spectra), 2-piece Ambicor, and 3-piece AMS 700 CX/LGX were included in the analysis. The most common patient comorbidities were CV disease (26.1%), DM (11.1%), and PD (12.4%). Primary etiology of ED: RP (27.4%), DM (20.3%), CVD (18.0%), PD (10.3%), and Priapism (1.4%), others (22.6%). Mean duration of ED is 6.2¡À4.1 years. Implant length was weakly negatively correlated with White/Caucasian (r=−0.18; P<0.01), history of RP (r=−0.13; P<0.01), PD as comorbidity (r=−0.16; P<0.01), venous leak (r=−0.08; P<0.01), and presence of stress incontinence (r=−0.13; P<0.01). Analyses showed weak positive correlations with Black/AA (r=0.32; P<0.01), CV disease as primary ED etiology (r=0.08; P<0.01) and pre-operative stretched penile length (r=0.18; P<0.01). There is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). Conclusions Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length.