Patient satisfaction study for the new Rigicon Infla10 inflatable penile prosthesis including single surgeon safety and outcomes data.

BACKGROUND

Rigicon is a newer inflatable penile prostheses (IPP) manufacturer that has produced the Infla10 IPP for countries outside the United States (US) since 2019, with Food and Drug Administration studies for approval of Infla10 in the US presently underway.

AIM

This study aims to report the first patient satisfaction, efficacy, and safety from revision data for the newly available Rigicon Infla10 IPP.

METHODS

A single surgeon's first 58 patients who underwent Rigicon Infla10 IPP implantation between 2019 and 2023 were included. Most patients (70%) received the Infla10 X (girth expansion) cylinder, and 30% received the Infla10 AX (length and girth expansion) model. Follow-up ranged from 4 to 42 months (median 19 months).

OUTCOMES

Outcomes measured were intraoperative and postoperative complications as well as patient-reported satisfaction.

RESULTS

Reoperation was required in 5 patients (8.6%). Complication rates were 1.7% urethral erosion (n = 1), 1.7% infection requiring explant (n = 1), and 5% mechanical malfunction due to tubing breakage at pump junction (n = 3). The tubing issue was addressed by the manufacturer, resulting in no additional mechanical concerns. Kaplan-Meier analysis demonstrated rates of cumulative survival of the device at 12, 24, and 36 months were 96.6%, 93.8%, and 78.2%, respectively. Overall, 53 patients (91.4%) were satisfied at 6 months postoperatively and would recommend the procedure. Diminished satisfaction was due to perceived penile shortening in 3 patients (5.1%) and difficulty learning pump cycling in 2 patients (3.4%).

CLINICAL IMPLICATIONS

This single surgeon series demonstrates high rates of patient satisfaction with appropriate early safety from revision.

STRENGTHS AND LIMITATIONS

Limitations include the retrospective nature of this study and short-term follow-up. Additional prospective studies incorporating a larger number of patients are warranted.

CONCLUSION

While very new in the marketplace, the Infla10 IPP shows promising early satisfaction, efficacy, and safety from revision.