Collaborative Urological Prosthetics Investigation Directive Research Group

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Loyola University
• Treatments: Amoxicillin-Potassium Clavulanate Combination; Ciprofloxacin; Doxycycline; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

1. Males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction.

2. 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:

1. 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.

2. Prior history of or current symptomatic urethral stricture.

3. History of cystitis caused by Tuberculosis.

4. Active Cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy.

5. Prior augmentation cystoplasty or cystectomy.

6. Systemic neuromuscular disease known to affect the lower urinary tract such as Spinal Cord Injury, Multiple Sclerosis or other condition leading to neurogenic bladder.

7. Antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study.

8. Cases where patients have had a prior penile prosthesis.

9. Any protected population (i.e. Prisoners)