Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery

ConditionsBPH With Urinary Obstruction Antibiotic Prophylaxis

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexMale

Age18+

SponsorOhio State University

About this trial

To compare the risk of infectious complications (UTI, pyelonephritis, sepsis, hospital admission, ED visits) for patients with an indwelling urinary catheter (urethral or suprapubic) or CIC receiving 3 or 7 days of peri-operative antibiotic prophylaxis at time of Holmium Laser Enucleation of the Prostate

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Candidate for HoLEP surgery 2. Must be 18 years or older. 3. The patient must be able to understand and willing to provide informed consent as described in this study protocol.

Disqualifiers

1. Under the age of 18 2. Refuse to provide informed consent 3. Anticipated need for perineal urethrostomy 4. History of multi-drug resistant organism on urine culture that is not susceptible to any oral agents

Trial design

Design model

Parallel

Treatments tested in this trial

antibiotic prophylaxis
Drug
we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: 3 day prophylaxisExperimental treatment 1 intervention

Group B: 7 day prophylaxisOther 1 intervention

Trial outcomes

Primary outcomes

Infectious complications

UTI, pyelonephritis, sepsis, hospital admission, ED visits

Time frame

0-90 days postoperatively

Secondary outcomes

healthcare utilization

hospital admission or ED visits occurring post HoLEP

Time frame

0-90days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: