Synchronous Ipsilateral High Submuscular Placement of Prosthetic Balloons and Reservoirs
Nicholas L. Kavoussi, MD; Matthias D. Hofer, MD; Boyd R. Viers, MD; Billy H. Cordon, MD; Ryan P. Mooney, MD; Travis J. Pagliara, MD; Jeremy M. Scott, BS; and Allen F. Morey, MD
ONLINE: January 2017 – The Journal of Sexual Medicine
Introduction and Goal
Synchronous implantation of an artificial urinary sphincter (AUS) and an inflatable penile prosthesis (IPP) is a safe and effective approach for addressing erectile dysfunction (ED) and urinary incontinence after prostatectomy.
Typically, devices are placed in the space of Retzius; however, this technique is not always suitable for patients who have had pelvic or groin surgery in the past or those who have previously had surgical devices implanted.
About five years ago, the authors of this study started placing reservoirs and pressure-regulating balloons (PRBs) in a high submuscular (HSM) location to avoid retropubic dissection. This technique is called synchronous ipsilateral HSM (SIHSM).
This study examines the relationship between this method and rates of mechanical failure or complications. It compares the results of ipsilateral and traditional bilateral placement of AUS PRBs and IPP reservoirs in men having synchronous implant surgery. The authors hypothesized that SIHSM would be safe and well tolerated compared to traditional approaches.
One surgeon performed 968 AUS and IPP surgeries at the authors’ institution from 2007 through 2015. For the first four years of the study period, PRBs were placed in the space of Retzius in a traditional approach. In 2011, SIHSM placement became the preferred method.
During the SIHSM procedures, the surgeon developed a long submuscular tunnel and placed the IPP reservoir and PRB there via a penoscrotal incision.
The surgeon chose an ipsilateral or bilateral approach depending on the patient’s past surgical history, past placement of prosthetic devices, and the ease of HSM tunnel development.
Patients were discharged within 24 hours. After 6 weeks, they were taught how to activate their AUS and IPP devices. Follow-up visits were scheduled for 3 months following surgery, then annually or as needed.
Review was retrospective with all-cause reoperation as the primary outcome. The researchers also looked at the reasons for reoperation, including infection, device erosion or extrusion, mechanical failure, and AUS-related urethral atrophy.
Forty-seven men underwent synchronous IPP and AUS implantation – 17 ipsilateral and 30 bilateral. Ipsilateral placement was associated with a higher incidence of high-risk patients, including those with a compromised urethra (88% vs. 33%) and prior pelvic radiation (59% vs. 27%).
The median follow-up time was 19 months. During that time, 12 patients needed reoperation (5 from the ipsilateral group and 7 from the bilateral group).
Ten of the 12 reoperations were due to AUS complications and nearly all patients in that category (also 10 out of 12) had compromised urethras.
The most common reason for reoperation was cuff erosion (4 of the 47 patients) with no differences between the ipsilateral and bilateral groups.
According to the authors, this study is the first to report on the synchronous ipsilateral placement of an AUS PRB and an IPP reservoir in a shared submuscular tunnel. However, they acknowledged that placing devices so close together raises concerns for mechanical problems or infections. In this study, “only a single balloon and reservoir failure was identified in each cohort.” Infection rates were similar between the ipsilateral and bilateral groups.
They added that patients with compromised urethras and those with penile implants were at higher risk for AUS cuff erosion. Further study could explore the safety of dual implantation for these patients.
The authors also acknowledged several limitations, which included the retrospective design and small sample. Other institutions may not have similar results, as the SIHSM technique is “novel” and best handled by “experienced implanters.”
“Although this initial SIHSM experience appears to be quite favorable, we recognize the potential problems inherent with reoperation when prosthetic devices are in close juxtaposition, especially in the setting of infection or cuff erosion,” they wrote. “We advise caution and increased attention to patient counseling in elderly men with compromised urethras seeking dual IPP and AUS implantation.”
Overall, they concluded, the SISHM approach “appears to be a safe strategy based on our early experience, without an increase in infectious or mechanical complications compared with traditional synchronous bilateral placement.”