Role of Prophylactic Postoperative Antibiotics in HoLEP

NCT05274672 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 022-046
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Urinary Tract Infections

Keywords

HoLEP; Prophylactic antibiotics; Urinary tract infection

Outcome Measures

Primary Outcomes (1)

• the rates of urinary tract infection within the 30-day post-operative period after HoLEP

  A urinary tract infection is defined as a positive urine culture .

  within 30 days after HoLEP

Secondary Outcomes (1)

• The incidence of irritative voiding symptoms after HoLEP and all the other urinary functional outcomes.

  6 months

Study Arms (2)

Patients not receiving postoperative antibiotics

EXPERIMENTAL

Patients who will not receive prophylactic postoperative antibiotics after HoLEP.

Procedure: Holmium Laser Enucleation of prostate

Patients receiving postoperative antibiotics

ACTIVE COMPARATOR

Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.

Drug: Nitrofurantoin; Drug: Cephalexin; Drug: Sulfamethoxazole Trimethoprim Combination; Drug: Ciprofloxacin; Procedure: Holmium Laser Enucleation of prostate

Interventions

Nitrofurantoin DRUG

Prophylactic postoperative antibiotic use

Also known as: Macrobid

Patients receiving postoperative antibiotics

Cephalexin DRUG

Prophylactic postoperative antibiotic use

Also known as: Keflex

Patients receiving postoperative antibiotics

Ciprofloxacin DRUG

Prophylactic postoperative antibiotic use

Also known as: Cipro

Patients receiving postoperative antibiotics

Holmium Laser Enucleation of prostate PROCEDURE

Endoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue

Also known as: HoLEP

Patients not receiving postoperative antibiotics; Patients receiving postoperative antibiotics

Sulfamethoxazole Trimethoprim Combination DRUG

Prophylactic postoperative antibiotic use

Also known as: BACTRIM

Patients receiving postoperative antibiotics

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: The Benign prostatic pathology is applicable only in male patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor Research Institute: lead
• Albert Einstein Healthcare Network: collaborator

Study Sites (2)

Einstein Healthcare network

Philadelphia, Pennsylvania, 19141, United States

Location

Baylor Scott and White

Temple, Texas, 76508, United States

Location

Related Publications (6)

• Tennyson LE, Averch TD. An Update on Fluoroquinolones: The Emergence of a Multisystem Toxicity Syndrome. Urol Pract. 2017 Sep;4(5):383-387. doi: 10.1016/j.urpr.2016.08.004. Epub 2016 Oct 24.

  PMID: 37592645 BACKGROUND

• Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23.

  PMID: 31441676 BACKGROUND

• Ivan SJ, Sindhwani P. Comparison of guideline recommendations for antimicrobial prophylaxis in urologic procedures: variability, lack of consensus, and contradictions. Int Urol Nephrol. 2018 Nov;50(11):1923-1937. doi: 10.1007/s11255-018-1971-1. Epub 2018 Aug 25.

  PMID: 30145652 BACKGROUND

• Das AK, Teplitsky S, Humphreys MR. Holmium laser enucleation of the prostate (HoLEP): a review and update. Can J Urol. 2019 Aug;26(4 Suppl 1):13-19.

  PMID: 31481144 BACKGROUND

• Ishikawa K, Maruyama T, Kusaka M, Shiroki R, Hoshinaga K. [The state of antimicrobial prophylaxis for holmium laser enucleation of the prostate : HoLEP and the results of a questionnaire survey]. Hinyokika Kiyo. 2011 Oct;57(10):539-43. Japanese.

  PMID: 22089150 BACKGROUND

• Davuluri M, Bernstein AP, Fram E, Watts KL. Variations in Perioperative Antibiotic Prescriptions Among Academic Urologists After Ambulatory Endoscopic Urologic Surgery: Impact on Infection Rates and Validation of 2019 Best Practice Statement. Urology. 2020 Dec;146:101-106. doi: 10.1016/j.urology.2020.07.049. Epub 2020 Aug 8.

  PMID: 32777364 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Tract Infections

Interventions

Nitrofurantoin; Cephalexin; Trimethoprim, Sulfamethoxazole Drug Combination; Ciprofloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Trimethoprim; Pyrimidines; Drug Combinations; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Marawan M. El Tayeb, MD

  Baylor Scott and White Health Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study to be multi-institutional, double armed, randomized controlled trial between 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 2 centers within almost one year, between March 2022 and March 2023. Patients will be randomized in to 2 groups: * Group I: Experimental Group (not receiving antibiotics). * Group II: Control Group (receiving 3 days of antibiotics after surgery) Each center will have a study coordinator (resident and/or fellow) that will be responsible for randomization using closed envelope technique.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2023
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)