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Extended Antibiotics for Penile Prosthesis Infection (CUPID Trial)

Phase < 1

Waitlist Available

Led By Sarah Faris, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of cystitis caused by Tuberculosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether 6 extra days of antibiotics can lower the risk of infection for men getting a penile prosthesis.

Who is the study for?

This trial is for males aged 35-90 with erectile dysfunction who are getting a specific penile prosthesis (AMS 700) and haven't used antibiotics in the last week. It's not for those with prior prostheses, urinary tract foreign bodies, urethral strictures, tuberculosis-related cystitis, recent chemotherapy, bladder surgery history or systemic neuromuscular diseases.

What is being tested?

The study tests if taking oral antibiotics (Doxycycline, Augmentin, Bactrim or Ciprofloxacin) for an extra six days after implanting a penile prosthesis can reduce infection risk. Participants will receive one of these antibiotics to see which is most effective.

What are the potential side effects?

Possible side effects from the antibiotics may include stomach upset like nausea and diarrhea; allergic reactions such as rashes; yeast infections; and rarely more serious issues like tendon problems or nerve damage.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bladder inflammation due to Tuberculosis.

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I have a condition like MS that affects bladder control.

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I have or had a painful narrowing of the urethra.

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I have not taken antibiotics in the last week and do not need them now.

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I have had bladder enlargement or removal surgery.

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I am currently on Cytoxan or immunosuppressive chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Additional 6 days of oral antibiotics after Penile prosthesis placement does not decrease the risk of superficial tissue infections after penile prothesis implantation.