Collaborative Urological Prosthetics Investigation Directive Research Group (CUPID)

The University of Chicago

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Erectile Dysfunction; Penile Prosthesis Infection

Treatments: Drug: Doxycycline; Drug: Augmentin; Drug: Ciprofloxacin; Drug: Bactrim

Study type: Interventional

Funder types: Other

Identifiers

NCT05100654

IRB19-1757

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

No post-operative oral antibiotics

No Intervention group

Description:

Patients will only receive 24hr of IV peri-operative antibiotics

6 days of oral antibiotics

Active Comparator group

Description:

Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics

Treatment:

Drug: Bactrim

Drug: Augmentin

Drug: Ciprofloxacin

Drug: Doxycycline