Collaborative Urological Prosthetics Investigation Directive Research Group

Early Phase 1

Active, not recruiting

• Conditions: Erectile Dysfunction; Penile Prosthesis Infection
• Interventions: Drug: Doxycycline; Drug: Ciprofloxacin; Drug: Augmentin; Drug: Bactrim

• Registration Number: NCT05100654
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-29
• Study Start: 2022-04-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 800

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 days of oral antibiotics	Doxycycline	Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
6 days of oral antibiotics	Ciprofloxacin	Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
6 days of oral antibiotics	Augmentin	Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics
6 days of oral antibiotics	Bactrim	Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States