Role of Prophylactic Postoperative Antibiotics in HoLEP

February 10, 2026 updated by: Baylor Research Institute

Does Post-operative Antibiotic Prophylaxis Reduce Urinary Tract Infection Rates After Holmium Laser Enucleation of Prostate? a Prospective Randomized Multi-center Study

The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after Holmium laser enucleation of the prostate (HoLEP) reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Systemic antibiotic usage is the primary driver of antimicrobial resistance both in the index patient and the community. Limiting antibiotic use to indicated patients helps reduction of the risks of antimicrobial overuse, which include associated adverse events, development of multidrug resistant (MDR) organism strains, and increased health-related community burden. (1-3) Holmium laser enucleation of the prostate (HoLEP) has been increasingly used as an effective minimally invasive procedure for the management of enlarged prostate. (4) Most guidelines currently recommend the use of single-dose antibiotic prophylaxis prior to all transurethral procedures for the treatment of benign prostatic hyperplasia including HoLEP. (2,3) Although, most surgeons who perform HoLEP usually extend the antibiotics prophylaxis to 3-7 days or more after HoLEP to avoid the incidence of urinary tract infection. Currently no literature that supports the benefit of prescribing antibiotics routinely to all patients after HoLEP. (5, 6) 2. Significance: This clinical trial will provide insight into the benefit of prescribing antibiotics after HoLEP. This study can be practice-changing for urologists who perform HoLEP as it will decrease the prescription of unnecessary antibiotics. This has major implications for antibiotic stewardship in the field of urology.

3. Objectives & Specific Aims: The purpose of this study is to investigate whether prescribing a 3-day course of antibiotics after HoLEP reduces the risk of urinary tract infection. The findings of this trial will have a major impact on clinical practice to either justify the prescription of antibiotics after HoLEP or give urologists more confidence in not prescribing antibiotics prophylactically after HoLEP.

The specific aims of this study are:

  1. Avoid the possible unnecessary generalized prolonged antibiotic prophylaxis in patients with HoLEP.
  2. Identify the patient and procedure factors that increase the incidence of postoperative urinary tract infection.
  3. Possible selection of patients who can benefit from prolonged antibiotic prophylaxis.
  4. Help changing the urology practice towards more antibiotic stewardship.

4. Methodology: 4.1 Study Design.

Study to be multi-institutional, double armed, randomized controlled trial at Baylor Scott and White medical center in Temple, Texas and Albert Einstein Medical Center in Philadelphia.

The study will include 100 patients who will have HoLEP in the two centers within almost one year, between March 2022 and March 2023.

All patients will receive a single perioperative antibiotics per the American urological association guidelines. Patients will be randomized in to 2 groups:

  • Group I: Experimental Group (not receiving antibiotics).
  • Group II: Control Group (receiving three days of antibiotics after surgery)

Each center will have a study coordinator (resident and/or fellow) that will be responsible for randomization using the closed envelope technique.

4.2 Procedures/Methods.

Each patient's chart in the study will be subjected to analysis of:

  1. Preoperative assessment:

    • Detailed history and physical examination.

    • Investigations:

      • Routine laboratory investigations, urine analysis and culture, serum PSA.
      • IPSS, Q-max, and PVR

  2. Operative details:

    • Operative time, prostate volume
    • Estimated blood loss
    • Any intraoperative complications.
  3. Postoperative assessment:

During early postoperative follow up, the patient will be assessed for:

  • Irritative voiding symptoms, urinary urgency, urinary frequency, and urinary incontinence.
  • IPSS, Quality of life (QOL)
  • Assessment of PVR.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Healthcare Network
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott and White

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men > 40 years old with moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
  • Patient with negative preoperative urine culture.

Exclusion Criteria:

  • Patients with history of recurrent urinary tract infection or uro-sepsis.
  • Patient with preoperative infections
  • Patient with indwelling urethral catheter
  • Patient doing continuous intermitted catheterization (CIC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients not receiving postoperative antibiotics
Patients who will not receive prophylactic postoperative antibiotics after HoLEP.
Procedure: Holmium Laser Enucleation of prostate
Endoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue
Other Names:
  • HoLEP
Active Comparator: Patients receiving postoperative antibiotics
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
Procedure: Holmium Laser Enucleation of prostate
Endoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue
Other Names:
  • HoLEP
Drug: Nitrofurantoin
Prophylactic postoperative antibiotic use
Other Names:
  • Macrobid
Drug: Cephalexin
Prophylactic postoperative antibiotic use
Other Names:
  • Keflex
Drug: Sulfamethoxazole Trimethoprim Combination
Prophylactic postoperative antibiotic use
Other Names:
  • BACTRIM
Drug: Ciprofloxacin
Prophylactic postoperative antibiotic use
Other Names:
  • Cipro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rates of urinary tract infection within the 30-day post-operative period after HoLEP
Time Frame: within 30 days after HoLEP
A urinary tract infection is defined as a positive urine culture .
within 30 days after HoLEP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of irritative voiding symptoms after HoLEP and all the other urinary functional outcomes.
Time Frame: 6 months
Irritative voiding symptoms, postoperative hematuria, incontinence, urethral stricture, need for re-catheterization.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Albert Einstein Healthcare Network

Investigators

  • Principal Investigator: Marawan M. El Tayeb, MD, Baylor Scott and White Health Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2023

Primary Completion (Actual)

February 20, 2025

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All the published material will keep human information in an unidentifiable manner.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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