Collaborative Urological Prosthetics Investigation Directive Research Group

Erectile dysfunction is a common problem and the incidence increases with age. Penile prosthesis placement for medication refractory erectile dysfunction is well established with high success rates. However, infection remains a dreaded complication with significant patient morbidity requiring device explant. Device innovations such as antibiotic coating and adaptations in technique have led to device infection rate reduction to ~1-3% in the hands of high volume implanters in modern series. The study team will perform a non-inferiority trial of post-operative antibiotic prophylaxis for IPP procedures with InhibiZonetm coated AMS 700 devices to confirm the hypothesis that a prolonged postoperative antibiotic regimen does not influence infection-related outcomes in de-novo IPP placement. The study team will determine potential risk factors for prosthetic infections and which patients would benefit from an extended post-operative oral antibiotic course of 6 days along with other objectives.

Inclusion criteria

• Males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction.
• Males clinically indicated for de-novo InhibiZonetm coated AMS 700 devices IPP placement procedure per local clinical guidelines who have elected to pursue penile prosthesis as an ED treatment.

Exclusion criteria

• Patients with indwelling foreign body in the urinary tract > 24 hours prior to the procedure (i.e. foley catheter). Patients using clean intermittent catheterization will not be excluded.
• Prior history of or current symptomatic urethral stricture.
• History of cystitis caused by Tuberculosis.
• Active Cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy.
• Prior augmentation cystoplasty or cystectomy.
• Systemic neuromuscular disease known to affect the lower urinary tract such as Spinal Cord Injury, Multiple Sclerosis or other condition leading to neurogenic bladder.
• Antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study.
• Cases where patients have had a prior penile prosthesis.
• Any protected population (i.e. Prisoners)