Collaborative Urological Prosthetics Investigation Directive Research Group

Study Overview
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Brief Summary
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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.

Official Title
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Collaborative Urological Prosthetics Investigation Directive Research Group

Conditions
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Erectile Dysfunction, Penile Prosthesis Infection

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Ciprofloxacin
* Drug: Augmentin
* Drug: Bactrim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction