Back to resultsCollaborative Urological Prosthetics Investigation Directive Research Group (CUPID)
Primary Purpose
Erectile Dysfunction, Penile Prosthesis Infection
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Ciprofloxacin
Augmentin
Bactrim
Sponsored by
About this trial
This is an interventional prevention trial for Erectile Dysfunction focused on measuring Erectile Dysfunction
Eligibility Criteria
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)
Sites / Locations
- University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No post-operative oral antibiotics
6 days of oral antibiotics
Arm Description
Patients will only receive 24hr of IV peri-operative antibiotics
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
Outcomes
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
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.
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.
Full Information
NCT ID
NCT05100654
First Posted
September 30, 2021
Last Updated
June 1, 2023
Sponsor
University of Chicago
Collaborators
Loyola University
1. Study Identification
Unique Protocol Identification Number
NCT05100654
Brief Title
Collaborative Urological Prosthetics Investigation Directive Research Group
Acronym
CUPID
Official Title
Collaborative Urological Prosthetics Investigation Directive Research Group
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Loyola University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Penile Prosthesis Infection
Keywords
Erectile Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No post-operative oral antibiotics
Arm Type
No Intervention
Arm Description
Patients will only receive 24hr of IV peri-operative antibiotics
Arm Title
6 days of oral antibiotics
Arm Type
Active Comparator
Arm Description
Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Intervention Type
Drug
Intervention Name(s)
Augmentin
Intervention Description
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Intervention Type
Drug
Intervention Name(s)
Bactrim
Intervention Description
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
Primary Outcome Measure Information:
Title
Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention
Description
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 Outcome Measure Information:
Title
Additional 6 days of oral antibiotics after Penile prosthesis placement does not decrease the risk of superficial tissue infections after penile prothesis implantation.
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Faris, MD
Phone
773-702-2573
Email
sfaris@surgery.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Faris, MD
Organizational Affiliation
University of Chicago Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Faris, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share individual participant data that is de-identified available to all qualified investigators
IPD Sharing Time Frame
Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database
IPD Sharing Access Criteria
All qualified investigators who sign appropriate data use agreements with the University of Chicago
Learn more about this trial
Collaborative Urological Prosthetics Investigation Directive Research Group
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