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

Area of Science:

• Urology
• Medical Devices
• Prosthetics

Background:

• Rigicon, a newer inflatable penile prosthesis (IPP) manufacturer, has offered the Infla10 IPP outside the US since 2019.
• The Infla10 IPP is currently undergoing Food and Drug Administration (FDA) studies for US approval.

Purpose of the Study:

• To report the initial patient satisfaction, efficacy, and safety data from revision cases for the Rigicon Infla10 IPP.
• To evaluate the early performance of the Infla10 IPP in a clinical setting.

Main Methods:

• A retrospective review of the first 58 patients who received the Rigicon Infla10 IPP between 2019 and 2023.
• Patients received either the Infla10 X (girth) or Infla10 AX (length and girth) models, with follow-up ranging from 4 to 42 months (median 19 months).

Main Results:

• Reoperation was required in 8.6% of patients (n=5).
• Complication rates included 1.7% urethral erosion, 1.7% infection requiring explant, and 5% mechanical malfunction (tubing breakage), which was resolved by the manufacturer.
• 91.4% of patients reported satisfaction at 6 months, with diminished satisfaction attributed to perceived penile shortening or difficulty with pump cycling.

Conclusions:

• The Rigicon Infla10 IPP demonstrates high patient satisfaction and acceptable early safety profiles.
• This single-surgeon series suggests promising early efficacy and safety for the novel Infla10 IPP.
• Further prospective studies with larger patient cohorts are warranted to confirm these findings.