Collaborative Urological Prosthetics Investigation Directive Research Group (CUPID)

• ClinicalTrials.gov Identifier: NCT05100654
• Recruitment Status: Recruiting
• First Posted: October 29, 2021
• Last Update Posted: April 28, 2022
• Sponsor: University of Chicago
• Collaborator: Loyola University
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Erectile Dysfunction; Penile Prosthesis Infection	Drug: Doxycycline; Drug: Ciprofloxacin; Drug: Augmentin; Drug: Bactrim	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Collaborative Urological Prosthetics Investigation Directive Research Group
• Actual Study Start Date: April 22, 2022
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: January 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Sarah Faris, MD; 773-702-2573; sfaris@surgery.bsd.uchicago.edu

Locations

United States, Illinois

University of Chicago; Recruiting

Chicago, Illinois, United States, 60637

Contact: Sarah Faris, MD

Sponsors and Collaborators

University of Chicago

Loyola University

Investigators

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

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT05100654
• Other Study ID Numbers: IRB19-1757
• First Posted: October 29, 2021
• Last Update Posted: April 28, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We will share individual participant data that is de-identified available to all qualified investigators
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database
• Access Criteria: All qualified investigators who sign appropriate data use agreements with the University of Chicago

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Chicago:

Erectile Dysfunction

Additional relevant MeSH terms:

Erectile Dysfunction; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Doxycycline; Ciprofloxacin; Amoxicillin-Potassium Clavulanate Combination; Trimethoprim, Sulfamethoxazole Drug Combination; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents