Collaborative Urological Prosthetics Investigation Directive Research Group

Early Phase 1Active Not RecruitingNCT05100654

University of Chicago800 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

800

Conditions

Erectile Dysfunction Penile Prosthesis Infection

Interventions

DoxycyclineDRUG

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

CiprofloxacinDRUG

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

AugmentinDRUG

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

Eligibility

Sex: MALEMin age: 35 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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