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

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

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Key information

Conditions

BPH With Urinary Obstruction Antibiotic Prophylaxis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic Prophylaxis

Drug

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

Primary outcomes

Infectious complications

Time frame: 0-90 days postoperatively

UTI, pyelonephritis, sepsis, hospital admission, ED visits

Secondary outcomes

healthcare utilization

Time frame: 0-90days

hospital admission or ED visits occurring post HoLEP

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Lee, MD

CONTACT

[email protected]

614-293-8155

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Randomized Controlled Trial of 3 vs 7 Days for Perioperative Antibiotic Prophylaxis for Patients With an Indwelling Catheter Prior to Holmium Laser Enucleation of the Prostate

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Oct 6, 2025
Registry last updated: Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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