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Efficacy, reliability, and patient satisfaction with Rigicon Infla10 X and Infla10 AX inflatable penile prostheses: a
Bugra Cetin1, Steven K Wilson2, Britney L Atwater3
1Urology, Altinbas University Medicalpark Bahcelievler Hospital, 34160, Istanbul, Türkiye.
Introduction:
Inflatable penile prosthesis implantation is a well-established treatment option for men with erectile dysfunction refractory to conservative therapies. However, patient-reported outcome data for the Rigicon Infla10 prosthesis remain limited. This study aimed to evaluate 12-month patient-reported outcomes following primary implantation of Rigicon Infla10 X and Infla10 AX devices and to explore potential differences according to implant model and pump type.
Methods:
This retrospective single-center, single-surgeon cohort study included 275 patients who underwent primary Rigicon Infla10 X or Infla10 AX implantation between 2021 and 2024 and completed 12-month follow-up. Erectile function was assessed using the International Index of Erectile Function-Erectile Function domain (IIEF-EF), while postoperative satisfaction was evaluated using the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. Ease of inflation and deflation was assessed using a 10-point numeric rating scale. Subgroup analyses were performed according to implant model and pump type.
Results:
Mean preoperative IIEF-EF score increased from 6.09 ± 1.47 to 24.07 ± 1.78 at 12 months. The overall mean QoLSPP total score was 4.19 ± 0.16. QoLSPP scores did not differ significantly between the Infla10 X and Infla10 AX groups (4.20 ± 0.18 vs. 4.18 ± 0.16; P = .436). Patients using the Pulse pump reported significantly higher ease-of-inflation and ease-of-deflation scores compared with those using the earlier-generation pump (both P < .001), whereas QoLSPP total scores were similar between pump groups (P = .821). The overall complication rate was 5.5%, and device infection occurred in one patient (0.4%).
Discussion:
Primary Rigicon Infla10 implantation was associated with substantial improvement in erectile function and favorable patient-reported outcomes at 12 months. Although the Pulse pump was associated with improved ease-of-use ratings, these differences did not translate into higher overall satisfaction scores. Interpretation of pump-related comparisons should be cautious because pump type was era-dependent and not randomly assigned. Prospective studies with longer follow-up are warranted to confirm these findings and further evaluate device-related outcomes.
