Use of TYRX antibacterial envelope in inflatable penile prosthesis surgery: a prospective pilot study

Infection remains a major concern in inflatable penile prosthesis (IPP) surgery. Medtronic's TYRX Absorbable Antibacterial Envelope is a polypropylene mesh pocket delivering minocycline and rifampin for 7 days and fully absorbing in 9 weeks. It is currently FDA-approved for use with cardiac pacemakers and neuromodulation devices. There is no indication for use in IPP surgeries, particularly for enveloping the scrotal pump during implantation.

This pilot study evaluates the feasibility, safety, and early patient-reported outcomes with the use of the absorbable antibacterial envelope during IPP surgery.

Fifteen men who underwent primary or revision IPP placement by a single high-volume surgeon were enrolled between January and May 2025. Demographic and comorbidity data were collected. IPP pumps were placed in the absorbable antibacterial envelope and then positioned into a sub-dartos pouch; no other changes to standard-of-care surgical placement were made.

The primary endpoint was the patient's ability to locate and operate the pump within 6 weeks after surgery. Secondary endpoints included infection and mechanical malfunction within 6 months after surgery.

Fifteen patients were enrolled and followed for up to 6 months postoperatively. Patients were able to utilize the pump by the 6-week visit. More than half of participants were overall "very" or "extremely" satisfied (8/15, 53%) and confident (12/15, 80%) with the inflation and deflation process. No patient experienced infection or malfunction. One patient on anticoagulation and hemodialysis developed a scrotal hematoma, which resolved conservatively.

These findings support continued evaluation of the absorbable antibacterial envelope as an adjunctive infection-prevention strategy in prosthetic urology.

To our knowledge, this is the first study to evaluate the absorbable antibacterial envelope in IPP surgery. Limitations include its single-center design, small sample size, short duration of follow-up, and lack of a control group for patient-reported outcome comparisons. This study was underpowered to evaluate the antibacterial envelope's efficacy or long-term infection outcomes.

Use of the absorbable antibacterial envelope in IPP surgery appears feasible and safe, with patients being able to utilize the pump postoperatively. No infection or mechanical malfunctions were encountered.