Sweigert SE, Chuang E, Patel PM et al: Synchronous artificial urinary sphincter and inflatable penile prosthesis implantation: short-term outcomes from a state-wide claims database. Urol Pract 2021; 8: 565.

Use of a penile prosthesis (PP) and artificial urinary sphincter (AUS) for treatment of post-prostatectomy erectile dysfunction (ED) and stress urinary incontinence (SUI) has been well demonstrated. However, there are conflicting reports in the limited literature regarding whether these procedures should be combined in 1 surgical setting or staged.^1–7 We sought to evaluate the safety of performing these procedures in the same operative setting.⁸

Our study was a retrospective analysis using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Database (SID) and State Ambulatory Surgery Database (SASD) for the states of California (2007-2011) and Florida (2009-2014). ICD-9-CM diagnosis and CPT codes were used to identify adult males who underwent both PP and AUS implantation. Outcomes regarding readmissions, emergency room (ER) presentations and complications were reviewed. We extracted relevant patient and encounter data, and compared the characteristics and outcomes of patients who underwent PP and AUS implantation during the same surgical setting to those who did not.

A total of 20,593 patients were identified who underwent PP or AUS implantation. Of these, 245 underwent synchronous PP and AUS (1.2%). Patients undergoing synchronous PP-AUS procedures had significantly higher rates of 30-day readmission compared to PP alone (5.7% vs 3.4%, p=0.045), significantly higher 90-day readmission rates compared to solitary PP or AUS placement (13.9% vs 7.2%, p <0.001), and significantly higher 90-day readmissions than with PP alone (13.9% vs 6.5%, p <0.001; see table).

Synchronous PP-AUS procedures were also associated with significantly higher rates of device complications within 90 days (6.1% vs 3.4%, p=0.021), and specifically had higher rates of minor complications (8.89% vs 2.35%, p <0.001) than those undergoing solitary PP or AUS placement. There was no difference between combined procedures and solitary procedures with regard to 30-day or 90-day ER visits. There was also no significant difference seen with regard to major complications.

Dual implantation may be appealing to patients because it avoids 2 anesthetic settings and potentially minimizes the postoperative discomfort to 1 surgery. However, studies assessing the safety of synchronous PP and AUS placement are conflicting; while some studies have shown synchronous device placement to be safe and cost-effective, others have found increased risks of mechanical failure and infection. Current literature is limited to smaller case series, and even the use of larger databases such as the HCUP database used in our paper yield a small number of patients undergoing dual implantation. We present outcomes from 2 statewide, longitudinal claims databases representing the largest cohort of synchronous PP-AUS placements published to date.

The earliest case series in the literature was published in 1989 by Parulkar and Barrett.⁶ They presented their results from 65 patients who underwent dual device implantation, which described the procedure as both feasible and economical. A study from Sellers et al (2005) was also favorable: they found that with 15 patients who underwent dual implantation there was significantly reduced total operative time compared to individual staffed procedures, reduced cost and no increased risk of infections or erosions.⁵

Two more contemporary studies from single institutions also showed no significant difference in intraoperative complications or postoperative complications^1,4 between patients undergoing synchronous versus staged procedures. However, Segal et al noted significantly longer operative times associated with dual implantation.⁴ These studies were limited to 15 and 55 patients total.

An advantage of large clinical database literature is that it allows the researcher to look at less commonly performed operations across institutions and health care providers. Three recent database studies published from 2017 to 2019 also evaluated outcomes of dual device implantation compared to staged procedures.^2,3,7 The rates of dual implantation in these studies ranged from 1.6% to 4.1% of the total implant volume, similar to the 1.2% rate seen in our study, and likely represents the current clinical landscape. These studies had between 64 and 179 men who underwent synchronous PP-AUS placement. Two of these studies, ie Pederzoli² and Boysen⁷ et al, found no significant difference in 30-day and 90-day readmission rates between dual and solitary device implantation. However, Patel et al did find that compared to PP alone, combined procedures were associated with significantly higher rates of PP reoperation at 1 and 3 years.³

While unable to be evaluated by our study, there are a number of potential risk factors for infectious, tissue-related or device complications after prosthesis placement. Given the conflicting data, careful patient selection and counseling are necessary when offering synchronous PP-AUS device placement, which should potentially be avoided in populations at increased risk for complications.

Based on the results of our study, and in the context of the existing literature, we conclude that synchronous PP and AUS implantation is feasible, with potential cost savings to the patient. However, it may be associated with higher readmission rates, device complications and postoperative complications compared to staged procedures. Certainly, a patient-specific approach is needed when counseling patients on synchronous device placement. Further investigation is needed to better characterize the relative risks and benefits of synchronous versus asynchronous approaches.