Collaborative Urological Prosthetics Investigation Directive Research Group

NCT ID: NCT05100654

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2026-01-01

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.

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.

Conditions

Erectile Dysfunction; Penile Prosthesis Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No post-operative oral antibiotics

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

6 days of oral antibiotics

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

Group Type: ACTIVE_COMPARATOR

Doxycycline

Intervention Type: DRUG

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

Ciprofloxacin

Intervention Type: DRUG

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

Augmentin

Intervention Type: DRUG

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

Bactrim

Intervention Type: DRUG

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

Interventions

Doxycycline

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

Intervention Type: DRUG

Ciprofloxacin

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

Intervention Type: DRUG

Augmentin

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

Intervention Type: DRUG

Bactrim

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Faris, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Department of Surgery

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB19-1757

Identifier Type: -

Identifier Source: org_study_id