Experienced surgeons are concerned about reservoir placement when implanting inflatable penile prostheses (IPPs) in men who have had robotic-assisted laparoscopic prostatectomy (RALP), a recent study has concluded.
The surgeons were surveyed in November 2011 during a symposium on practice patterns for alternative reservoir placement (ARP). The symposium was part of the annual meeting of the Sexual Medicine Society of North America (SMSNA) and held in Las Vegas, Nevada.
Three-piece IPPs have become the “mainstay of therapy” for men with erectile dysfunction when other treatments are not effective. The devices include a pair of cylinders implanted into the penis, a pump, and a fluid-filled reservoir. When a man activates the pump, the reservoir releases fluid into the cylinders, creating the erection. When an erection is no longer desired, the fluid can be returned to the reservoir.
For men who have had RALP, however, the placement of the reservoir becomes problematic. Ordinarily, the reservoir would be placed in the space of Retzius. But this location is not always ideal for men who have had RALP.
Potential complications of reservoir placement include bladder, ureter, bowel, and vascular problems. Such complications are estimated to occur less than 1% of the time, although this rate may be higher because some instances may go unreported.
At the SMSNA meeting, over 100 surgeons attended the ARP symposium. The study authors noted that “most, if not all, experienced prosthetic implanters in the United States” are SMSNA members.
The audience used an automated response system to give opinions on six survey questions on reservoir placement, low-profile reservoirs, and physician training.
When asked whether RALP made reservoir placement in the space of Retzius difficult, 82% of the respondents answered “yes, sometimes” or “yes, frequently.”
Eighty-eight percent of the respondents said they sometimes or frequently felt that placing the reservoir in an ectopic location was better for patient safety.
Eighty-nine percent said they would sometimes or frequently use an alternative location more often now that low-profile reservoirs are widely available, even though 79% said their patients would sometimes or frequently notice a bulge in that area.
For 43% of respondents, low profile reservoirs would reduce their use of malleable and/or two-piece prostheses. (Malleable devices allow the man to manually move the penis into an erection. Two-piece devices do not have a reservoir; instead, the fluid is located in the pump itself.)
About 96% of the respondents felt that ARP should be part of physician training programs, even if such placement is considered “off-label” use.
The authors acknowledged that the survey consisted of physicians’ opinions and did not include clinical outcomes. However, they noted the potential impact of the results.
The SMSNA stance could affect U.S. Food and Drug Administration (FDA) approval of device labeling. It could also protect surgeons if they encounter problems related to ARP or are questioned about their reasons for using it.
The results also emphasize that physicians are interested in learning more about ARP, which could influence training methods. Currently, the IPP industry does not allow training in off-label device use.
Future studies on ARP with clinical outcomes are needed to support the survey results.
The Journal of Sexual Medicine
Karpman, Edward, MD, FACS, et al.
“Current Opinions on Alternative Reservoir Placement for Inflatable Penile Prosthesis among Members of the Sexual Medicine Society of North America”
(Full-text. First published online: May 16, 2013)
Sexual Medicine Society of North America
“Penile Implants – Erectile Dysfunction”