Role of Prophylactic Postoperative Antibiotics in HoLEP

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Avoid the possible unnecessary generalized prolonged antibiotic prophylaxis in patients with HoLEP. Identify the patient and procedure factors that increase the incidence of postoperative urinary tract infection. Possible selection of patients who can benefit from prolonged antibiotic prophylaxis. 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: Preoperative assessment: Detailed history and physical examination. Investigations: Routine laboratory investigations, urine analysis and culture, serum PSA. IPSS, Q-max, and PVR Operative details: Operative time, prostate volume Estimated blood loss Any intraoperative complications. 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.

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

Conditions
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Benign Prostatic Hyperplasia, Urinary Tract Infections

Intervention / Treatment
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* Drug: Nitrofurantoin
* Drug: Cephalexin
* Drug: Sulfamethoxazole Trimethoprim Combination
* Drug: Ciprofloxacin
* Procedure: Holmium Laser Enucleation of prostate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HoLEP, Prophylactic antibiotics, Urinary tract infection