- In this large population-based study, patient-related factors associated with significantly higher risk of prosthesis removal were non-black race, modified Charlson Comorbidity Index =2, diabetes and HIV-positive status
- Hospital-related factors associated with removal were non-teaching status, hospital location in the Midwestern region of the U.S., year of removal and higher surgeon volume
- The study demonstrated the costly nature of prosthesis removal, underscoring the importance of preventing complications
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When necessary, a penile prosthesis is removed due to an infection or mechanical complication. The risk factors for these complications, particularly mechanical failure, have not been thoroughly studied.
A team led by Kai Li, MD, urologic surgery resident, recently identified patient and hospital factors that predict penile prosthesis removal, findings that should be clinically useful for patient risk stratification and counseling. Their findings were published in the World Journal of Urology.
The researchers identified 5,085 patients who had a penile prosthesis implanted or explanted between 2003 and 2015 in the Premier Healthcare database, which contains records on about 45% of U.S. hospital discharges. Implantable prostheses accounted for 89%–96% of procedures.
Implantations of non-inflatable prostheses remained stable over time. These data highlight the continued role for non-inflatable penile prostheses, the researchers comment. They point out that non-inflatable prostheses are a good option for men with multiple comorbidities, decreased strength and/or poor manual dexterity.
Risk Factors for Removal
A total of 3,317 patients required removal of a penile prosthesis during the study period. The researchers compared them with a control group of 4,823 patients whose prostheses were not removed. On multivariate analysis, statistically significant risk factors for removal were as follows:
- Group 1 (removal due to infection, n=1930): Charlson Comorbidity Index (CCI) ≥2, uncomplicated or complicated diabetes and HIV-positive status
- Group 2 (removal due to mechanical complication, n=771): CCI ≥2 and uncomplicated diabetes were associated with higher risk of removal; black race was protective
- Group 3 (all removals where reason could not be determined, n=3,317): CCI ≥2, uncomplicated or complicated diabetes and HIV-positive status
To pinpoint the role of diabetes as a risk factor, the researchers modified each patient's CCI by subtracting one point for uncomplicated diabetes and two points for complicated diabetes. Even so, CCI predicted prosthesis removal in all groups, they note, which underscores the importance of comorbidities and baseline medical health as risk factors.
The researchers have no explanation about why black race appeared to be protective in group 2.
The researchers note the database they reviewed relies on standard diagnostic codes, which do not distinguish between an inflatable and non-inflatable prosthesis or between device failure versus erosion or migration.
Other Explanations for Removal
Other characteristics predicted more explantations relative to implantations:
- Teaching hospitals were significantly less likely than non-teaching hospitals to remove prostheses, perhaps reflecting a skewed distribution of urologists
- Hospitals in the Western region of the U.S. were the least likely to remove prostheses, and hospitals in the Midwest were most likely
- There were significantly more removals during 2012–2015 than during 2003–2005, possibly because of device age
- As might be expected, high-volume surgeons (≥5 cases/year) were more likely than others to remove prostheses
Cost Analysis of Removal
This was the first study to investigate the cost of removal due to mechanical failure and to compare the costs of removal for infectious versus mechanical complications.
Overall, the median hospitalization cost was $10,878.
Removals due to infection cost a median of $11,252 versus $8,602 for removals due to mechanical complications, but the $1,580 difference was not statistically significant.
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