Validation of the Patient Global Impression of Improvement for Penile Prosthesis.

Background: No consensus on the preferred means of evaluating patients after surgical placement of an inflatable penile prosthesis (IPP) currently exists. Many self-assessment questionnaires are available, but none specifically targets patients with IPPs. The purpose of this study was to assess the construct validity of the Patient Global Impression of Improvement (PGI-I) for evaluating patient satisfaction after placement of an IPP.

Methods: We conducted a multicenter prospective trial and enrolled patients who elected to have a 3-piece IPP surgically implanted. Postoperatively, patients completed the Sexual Health Inventory for Men (SHIM), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and PGI-I at 3, 6, and 12 months. The Pearson correlation coefficient (PCC) was used to compare scores over time.

Results: Fifty-six patients were enrolled, and complete data were available for 39 patients. At 3 months, the PGI-I correlated with the EDITS (PCC=0.83, <0.01) and with the SHIM (PCC=0.73, <0.01). At 6 months, the PGI-I correlated with the EDITS (PCC=0.74, <0.01). At 6 months, the PCC between the PGI-I and the SHIM was 0.41 (<0.05). At 12 months, the PCC between the PGI-I and the EDITS was 0.83 (<0.01), and the PCC between the PGI-I and the SHIM was 0.61 (<0.01).

Conclusions: Overall, the PGI-I appears to correlate with both the SHIM and EDITS and is a valid evaluation tool for use with patients after IPP placement.