Clinical trial NCT05274672: Role of Prophylactic Postoperative Antibiotics in HoLEP
Official title: Does Post-operative Antibiotic Prophylaxis Reduce Urinary Tract Infection Rates After Holmium Laser Enucleation of Prostate? a Prospective Randomized Multi-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Urinary Tract Infections
Keywords: HoLEP
Prophylactic antibiotics
Urinary tract infection
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Albert Einstein Healthcare Network
First posted: 2022-03-10
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: the rates of urinary tract infection within the 30-day post-operative period after HoLEP
timeFrame: within 30 days after HoLEP
Secondary outcomes:
measure: The incidence of irritative voiding symptoms after HoLEP and all the other urinary functional outcomes.
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Healthcare network
state: Pennsylvania
city: Temple
country: United States
facility: Baylor Scott and White
state: Texas
Study officials:
affiliation: Baylor Scott and White Health Medical Center
name: Marawan M. El Tayeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.