(321) COMPARING PRELIMINARY DEMOGRAPHICS AND PATIENT SATISFACTION BY LOCATION OF 3-PIECE IPP RESERVOIR: IT MATTERS

Abstract Introduction Placement of the 3-piece AMS 700 with MS Pump inflatable penile prosthesis (IPP) is one surgical treatment for erectile dysfunction (ED). Historically, the reservoir is often placed in the extraperitoneal, prevesical space (also known as retropubic space or space of Retzius), though surgeons may choose a non-traditional or ectopic reservoir location. Objective Here we review patient demographics and patient satisfaction responses from the It MATTERS registry to compare groups of men whose AMS 700 reservoir was placed in a prevesical or ectopic space. Methods It MATTERS is a prospective, multi-center registry with follow-up occurring post-surgery and at 6 months, 12 months, and annually thereafter to capture key data throughout the expected lifetime of each penile prosthesis (clinicaltrials.gov NCT04200937). Men who received an AMS 700 with MS Pump with Inhibizone were put into groups based on reservoir location: prevesical and ectopic space. Enrolled patients were men aged 18 years or older who have chronic, organic ED. Results Currently, 54 AMS 700 have been implanted with the reservoirs located in either the prevesical (N = 38) or ectopic space (N = 16) across eight US sites (Table 1). There were no significant differences in patient age, height, weight, or BMI between groups, suggesting the patient’s physical composition may not be a significant factor in choosing the reservoir location. The general medical history of patients in both groups was similar, though patients with reservoirs placed ectopically had significantly more “other” diagnoses falling outside of those previously listed. The mean duration of ED was 9.2 years overall and the difference between groups was not significant (p = 0.718). The most common etiology of ED in the ectopic space was prostatectomy in 75.0% (12/16) compared to 13.9% (5/36) in the prevesical space group (p < 0.001). Post-surgery non-validated, reservoir satisfaction follow-up surveys were conducted between 0 and 90 days post-surgery. There were 34 responses at the post-surgery follow-up (prevesical space, N = 22 and ectopic location, N = 12). In each group, a majority of patients said they were satisfied or very satisfied with the reservoir location, which was not statistically significant between the groups (Table 2). As far as the patient’s level of physical comfort with the area of the reservoir, 54.5% (12/22) of the prevesical space group said they were comfortable or very comfortable, while 66.7% (8/12) of men with reservoirs in an ectopic location responded similarly. There were no statistically significant differences in overall patient satisfaction of reservoir location or level of physical comfort in either group (p = 0.134 and p = 0.623, respectively). Both groups of patients were asked whether they believed they felt the reservoir in the time since surgery, and a greater number of patients with a reservoir in the prevesical space responded “yes” than those with a reservoir in an ectopic location (54.4% (12/22) vs. 25.0% (3/12), respectively), though this difference was not significant (p = 0.097). Conclusions It MATTERS allows for the comparison of patient satisfaction in patients who have different locations of an AMS 700 reservoir. Further enrollment and larger subgroups will allow for a more detailed understanding of differences in these groups over time. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific Corporation. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: All authors act as consultants, employees, or shareholders of Boston Scientific Corporation.