Patient-reported outcomes after revision to the Rigicon® Infla10 inflatable penile prosthesis: a multicentre retrospective registry cohort with a cross-sectional telephone survey

Abstract

Revision of an inflatable penile prosthesis (IPP) is technically more demanding than primary implantation and usually requires complete IPP removal and replacement. In selected revision cases, patient expectations or surgeon preference may lead to substitution with an IPP from a different manufacturer. This study evaluated patient-reported outcomes in men undergoing revision from an IPP from another manufacturer to the Rigicon ® Infla10 IPP. This retrospective registry cohort included a cross-sectional postoperative telephone survey. Men who underwent complete explantation of an IPP made by another manufacturer, followed by implantation of the Rigicon ® Infla10, were identified in the Rigicon Post-Implant Follow-up Registry. During a single postoperative interview, participants rated their current Infla10 and retrospectively recalled their prior IPP. Overall satisfaction and perceived rigidity for both devices, ease of inflation and deflation, preference, and willingness to recommend the Infla10 were assessed. Among 62 participants from 11 countries, median postrevision follow-up was 20.8 months (IQR, 18.4–21.7). Mean (SD) recalled satisfaction with the prior IPP was 71.8% (6.5), compared with 94.4% (3.7) for the current Infla10. The mean within-participant difference was 22.6% points (BCa paired-bootstrap 95% CI, 21.0–25.3; Wilcoxon p < 0.001). Good or excellent rigidity was recalled for the prior IPP by 38/62 participants (61.3%) and reported for the current Infla10 by 56/62 (90.3%); 21 improved and 3 worsened (exact McNemar p = 0.0003). In this registry-based series, participants reported high current satisfaction and favorable current rigidity after revision to the Infla10. The uncontrolled design, retrospective recall of the prior IPP, unvalidated questionnaire, and non-participation of 37/99 eligible patients limit interpretation. These findings are hypothesis-generating and require validation using prospective, validated assessments and an active comparator.

The authors' abstract, as published at the source. BMC Urology, 2026 · DOI ↗