Active — Not RecruitingEarly Phase 1

Collaborative Urological Prosthetics Investigation Directive Research Group

United States800 participantsStarted 2022-04-22

Plain-language 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.

Who can participate

Age range35 Years – 90 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention

Timeframe: 12 months

Trial details

NCT IDNCT05100654

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Erectile Dysfunction trials