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

NCT07209150 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025HoLEP_periopabx
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

BPH With Urinary Obstruction; Antibiotic Prophylaxis

Keywords

bph; urinary retention; antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Infectious complications

  UTI, pyelonephritis, sepsis, hospital admission, ED visits

  0-90 days postoperatively

Secondary Outcomes (1)

• healthcare utilization

  0-90days

Study Arms (2)

3 day prophylaxis

EXPERIMENTAL

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

Drug: antibiotic prophylaxis

7 day prophylaxis

OTHER

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

Drug: antibiotic prophylaxis

Interventions

antibiotic prophylaxis DRUG

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

3 day prophylaxis; 7 day prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Ohio State University: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Central Study Contacts

Matthew Lee, MD

CONTACT

614-293-8155; matthew.lee@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who are eligible to undergo HoLEP and have an indwelling urinary catheter or perform CIC will be randomized to different durations of peri-operative antibiotic prophylaxis

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share