Role of Prophylactic Postoperative Antibiotics in HoLEP

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05274672
• Other study ID #: 022-046
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Baylor Research Institute
• Contact: Marawan M. El Tayeb, MD
• Phone: 854-724-1773
• Email: marawan.eltayeb[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Infections
• Prostatic Hyperplasia
• Urinary Tract Infections

Intervention

Drug:
• Nitrofurantoin
Prophylactic postoperative antibiotic use
• Cephalexin
Prophylactic postoperative antibiotic use
• Sulfamethoxazole Trimethoprim Combination
Prophylactic postoperative antibiotic use
• Ciprofloxacin
Prophylactic postoperative antibiotic use

Procedure:
• Holmium Laser Enucleation of prostate
Endoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue

Locations

Country	Name	City	State
United States	Einstein Healthcare network	Philadelphia	Pennsylvania
United States	Baylor Scott and White	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Tennyson LE and Averch TD: An update on fluoroquinolones: the emergence of a multisystem toxicity syndrome. Urol Pract 2017; 4: 383.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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