Collaborative Urological Prosthetics Investigation Directive Research Group

NCT05100654 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB19-1757
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Penile Prosthesis Infection

Keywords

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  12 months

Study Arms (2)

No post-operative oral antibiotics

NO INTERVENTION

Patients will only receive 24hr of IV peri-operative antibiotics

6 days of oral antibiotics

ACTIVE COMPARATOR

Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics

Drug: Doxycycline; Drug: Ciprofloxacin; Drug: Augmentin; Drug: Bactrim

Interventions

Ciprofloxacin DRUG

Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function

6 days of oral antibiotics

Augmentin DRUG

Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function

6 days of oral antibiotics

Bactrim DRUG

Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function

6 days of oral antibiotics

Doxycycline DRUG

Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function

6 days of oral antibiotics

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• Loyola University: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Doxycycline; Ciprofloxacin; Amoxicillin-Potassium Clavulanate Combination; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Sulfones; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sarah Faris, MD

  University of Chicago Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 29, 2021
• Study Start: April 22, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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

Locations

US (1)