Collaborative Urological Prosthetics Investigation Directive Research Group (CUPID)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    800
  • sponsor
    University of Chicago
Updated on 13 May 2022

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.

Details
Condition Erectile Dysfunction, Penile Prosthesis Infection
Treatment Ciprofloxacin, doxycycline, Augmentin, Bactrim, Bactrim
Clinical Study IdentifierNCT05100654
SponsorUniversity of Chicago
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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