Collaborative Urological Prosthetics Investigation Directive Research Group (CUPID)

January 29, 2026 updated by: University of Chicago
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No post-operative oral antibiotics
Patients will only receive 24hr of IV peri-operative antibiotics
Active Comparator: 6 days of oral antibiotics
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
Drug: Doxycycline
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Drug: Ciprofloxacin
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Drug: Augmentin
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Drug: Bactrim
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention
Time Frame: 12 months
From day of surgery through 1 year we are hoping to show that additional 6 days of oral antibiotics do not decrease the risk of penile prosthesis infection requiring surgical intervention for device removal.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional 6 days of oral antibiotics after Penile prosthesis placement does not decrease the risk of superficial tissue infections after penile prothesis implantation.
Time Frame: 12 months
From day of surgery through 1 year we are hoping to show that additional 6 days of oral antibiotics do not decrease the risk of superficial skin infection after penile prosthesis placement.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Loyola University

Investigators

  • Principal Investigator: Sarah Faris, MD, University of Chicago Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB19-1757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share individual participant data that is de-identified available to all qualified investigators

IPD Sharing Time Frame

Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database

IPD Sharing Access Criteria

All qualified investigators who sign appropriate data use agreements with the University of Chicago

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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