Detection of leakage in inflatable genitourinary devices.

OBJECTIVES

Improved manufacturing techniques and stronger materials have significantly reduced but not eliminated the incidence of hydraulic leakage in the inflatable genitourinary devices. This study was designed to test the efficacy of pressure dissipation and volume loss as potential tests for the detection of site-specific hydraulic leakage in the inflatable penile prosthesis (IPP) and the artificial sphincter (AS) and compare their efficacy with the current standard--the ohmmeter technique.

METHODS

Five IPPs and ASs were dismantled to achieve five reservoirs and cuff-pump assemblies. Each component was inspected visually and then tested for volume, pressure, and electrical resistance over 5 minutes. Next a needle puncture was deliberately made in these components, and the experiment was repeated. The in vivo pseudocapsule was simulated by an elastic covering, made from antiembolic hose.

RESULTS

The techniques of pressure, volume, and ohmmeter testing were not able to detect current leakage in all the components, with the pseudocapsule in place.

CONCLUSIONS

None of the currently available tests qualify for the label of "gold standard" in accurately detecting hydraulic leakage. We currently recommend testing the device's integrity by visual inspection in vivo, starting with the reservoirs. If a leakage is detected, the reservoir alone is replaced. If no leakage is found, we recommend that the entire unit be removed and replaced. If the malfunctioning device is more than 2 years old, we suggest that it be entirely replaced.