Efficacy, reliability, and patient satisfaction with Rigicon Infla10 X and Infla10 AX inflatable penile prostheses: a...

Area of Science:

• Urology
• Medical Devices
• Patient-Reported Outcomes

Background:

• Inflatable penile prosthesis (IPP) implantation is a standard treatment for erectile dysfunction (ED) resistant to other therapies.
• Limited patient-reported outcome data exists for the Rigicon Infla10 prosthesis.
• Evaluating outcomes of IPP is crucial for patient counseling and device selection.

Purpose of the Study:

• To assess 12-month patient-reported outcomes after primary implantation of Rigicon Infla10 X and Infla10 AX devices.
• To explore differences in outcomes based on implant model and pump type.
• To evaluate changes in erectile function and patient satisfaction.

Main Methods:

• Retrospective, single-center cohort study of 275 patients undergoing primary Rigicon Infla10 implantation (2021-2024).
• Erectile function assessed via International Index of Erectile Function-Erectile Function domain (IIEF-EF).
• Patient satisfaction measured by Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire and ease-of-use ratings.

Main Results:

• Significant improvement in mean IIEF-EF scores from 6.09 preoperatively to 24.07 at 12 months.
• Overall mean QoLSPP score was 4.19; no significant difference between Infla10 X and AX models.
• Pulse pump users reported higher ease-of-inflation/deflation (P < .001), but QoLSPP scores were similar between pump groups (P = .821). Overall complication rate was 5.5%.

Conclusions:

• Primary Rigicon Infla10 implantation leads to significant erectile function improvement and favorable patient-reported outcomes at 12 months.
• The Pulse pump enhances ease of use, but this did not significantly impact overall satisfaction scores.
• Further prospective studies are needed to confirm findings, especially regarding pump-type comparisons due to non-random assignment.