Erectile DysfunctionEarly Phase 1CUPIDNCT05100654
Collaborative Urological Prosthetics Investigation Directive Research Group
A Early Phase 1 study testing Doxycycline, Ciprofloxacin and Augmentin in people with Erectile Dysfunction and Penile Prosthesis Infection, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 90 years, men only
- Conditions the study is for
- Erectile Dysfunction, Penile Prosthesis Infection
- What is being tested?
- Doxycycline, Ciprofloxacin and Augmentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 1 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Doxycycline, Ciprofloxacin, Augmentin, Bactrim
- Keywords
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
BactrimDrug
Patients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function
| Study group | Role | What they receive |
|---|---|---|
| No post-operative oral antibiotics | No intervention | Patients will only receive 24hr of IV peri-operative antibiotics |
| 6 days of oral antibiotics | Active comparator | Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics Receives: Drug: Doxycycline; Drug: Ciprofloxacin; Drug: Augmentin; Drug: Bactrim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start22 Apr 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University
- Responsible party
- Sponsor
- Investigators
- Sarah Faris, MD, Principal investigator, University of Chicago Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100654
- Sponsor's protocol ID
- IRB19-1757
- Acronym
- CUPID
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2021
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share individual participant data that is de-identified available to all qualified investigators
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Urological Prosthetics Investigation Directive Research Group
- ClinicalTrials.gov ID
- NCT05100654
- Acronym / sponsor ID
- CUPID / IRB19-1757
- Conditions
- Erectile Dysfunction, Penile Prosthesis Infection
- Keywords
- Erectile Dysfunction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Loyola University
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No post-operative oral antibiotics | No intervention | –Patients will only receive 24hr of IV peri-operative antibiotics |
| 6 days of oral antibiotics | Active comparator | Drug: Doxycycline, Drug: Ciprofloxacin, Drug: Augmentin, Drug: BactrimPatients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclinePatients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function | Drug | 6 days of oral antibiotics |
| CiprofloxacinPatients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function | Drug | 6 days of oral antibiotics |
| AugmentinPatients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function | Drug | 6 days of oral antibiotics |
| BactrimPatients will be given 6 days of oral antibiotics based on local biograms, patient allergies and renal and liver function | Drug | 6 days of oral antibiotics |
Primary outcome
Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention
Time frame: 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.
1 secondary outcome
Additional 6 days of oral antibiotics after Penile prosthesis placement does not decrease the risk of superficial tissue infections after penile prothesis implantation.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes. We will share individual participant data that is de-identified available to all qualified investigators
Related trials for Erectile Dysfunction
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Faris, MD principal investigator
University of Chicago Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Doxycycline, Ciprofloxacin and Augmentin in people with Erectile Dysfunction and Penile Prosthesis Infection, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional 6 days of oral antibiotics after Penile prothesis placement does not decrease the risk of device infection leading to surgical intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.