CUPID: Collaborative Urological Prosthetics Investigation Directive Research Group

Sponsor

University of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT05100654

Collaborator

Loyola University (Other)

800

Enrollment

Location

Arms

32.4

Anticipated Duration (Months)

24.7

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jan 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

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

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

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]
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

Criteria

Ages Eligible for Study:

35 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago
Loyola University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT05100654

Other Study ID Numbers:

IRB19-1757

First Posted:

Oct 29, 2021

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Chicago

Erectile Dysfunction

Additional relevant MeSH terms:

Erectile Dysfunction

Doxycycline

Ciprofloxacin

Amoxicillin-Potassium Clavulanate Combination

Trimethoprim, Sulfamethoxazole Drug Combination

Study Results

No Results Posted as of Apr 28, 2022