search
Back to results

Role of Prophylactic Postoperative Antibiotics in HoLEP

Primary Purpose

Benign Prostatic Hyperplasia, Urinary Tract Infections

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitrofurantoin
Cephalexin
Sulfamethoxazole Trimethoprim Combination
Ciprofloxacin
Holmium Laser Enucleation of prostate
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring HoLEP, Prophylactic antibiotics, Urinary tract infection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Einstein Healthcare network
  • Baylor Scott and White

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients not receiving postoperative antibiotics

Patients receiving postoperative antibiotics

Arm Description

Patients who will not receive prophylactic postoperative antibiotics after HoLEP.

Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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.

Full Information

First Posted
March 2, 2022
Last Updated
March 9, 2022
Sponsor
Baylor Research Institute
Collaborators
Albert Einstein Healthcare Network
search

1. Study Identification

Unique Protocol Identification Number
NCT05274672
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor Research Institute
Collaborators
Albert Einstein Healthcare Network

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Urinary Tract Infections
Keywords
HoLEP, Prophylactic antibiotics, Urinary tract infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients not receiving postoperative antibiotics
Arm Type
Experimental
Arm Description
Patients who will not receive prophylactic postoperative antibiotics after HoLEP.
Arm Title
Patients receiving postoperative antibiotics
Arm Type
Active Comparator
Arm Description
Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP.
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Other Intervention Name(s)
Macrobid
Intervention Description
Prophylactic postoperative antibiotic use
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Other Intervention Name(s)
Keflex
Intervention Description
Prophylactic postoperative antibiotic use
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole Trimethoprim Combination
Other Intervention Name(s)
BACTRIM
Intervention Description
Prophylactic postoperative antibiotic use
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Other Intervention Name(s)
Cipro
Intervention Description
Prophylactic postoperative antibiotic use
Intervention Type
Procedure
Intervention Name(s)
Holmium Laser Enucleation of prostate
Other Intervention Name(s)
HoLEP
Intervention Description
Endoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue
Primary Outcome Measure Information:
Title
the rates of urinary tract infection within the 30-day post-operative period after HoLEP
Description
A urinary tract infection is defined as a positive urine culture .
Time Frame
within 30 days after HoLEP
Secondary Outcome Measure Information:
Title
The incidence of irritative voiding symptoms after HoLEP and all the other urinary functional outcomes.
Description
Irritative voiding symptoms, postoperative hematuria, incontinence, urethral stricture, need for re-catheterization.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The Benign prostatic pathology is applicable only in male patients.
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marawan M. El Tayeb, MD
Phone
854-724-1773
Email
marawan.eltayeb@bswhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Ghiraldi, DO
Phone
215-456-4600
Email
Ghiralde@einstein.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marawan M. El Tayeb, MD
Organizational Affiliation
Baylor Scott and White Health Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Einstein Healthcare network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Ghiraldi, DO
Phone
215-456-4600
Email
Ghiralde@einstein.edu
Facility Name
Baylor Scott and White
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marawan El Tayeb, MD
Phone
854-724-1773
Email
marawan.eltayeb@bswhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All the published material will keep human information in an unidentifiable manner.
Citations:
Citation
Tennyson LE and Averch TD: An update on fluoroquinolones: the emergence of a multisystem toxicity syndrome. Urol Pract 2017; 4: 383.
Results Reference
background
PubMed Identifier
31441676
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.
Results Reference
background
PubMed Identifier
30145652
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.
Results Reference
background
PubMed Identifier
31481144
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.
Results Reference
background
PubMed Identifier
22089150
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.
Results Reference
background
PubMed Identifier
32777364
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.
Results Reference
background

Learn more about this trial

Role of Prophylactic Postoperative Antibiotics in HoLEP

We'll reach out to this number within 24 hrs