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

The Ohio State University

Status and phase: Not yet enrolling; Phase 3

Conditions: BPH With Urinary Obstruction; Antibiotic Prophylaxis

Treatments: Drug: antibiotic prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT07209150

2025HoLEP_periopabx

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

3 day prophylaxis

Experimental group

Description:

3 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 1 day prior to surgery). macrobid if preoperative culture is negative

Treatment:

Drug: antibiotic prophylaxis

7 day prophylaxis

Other group

Description:

7 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 4 day prior to surgery). macrobid if preoperative culture is negative

Treatment:

Drug: antibiotic prophylaxis