Benign Prostatic HyperplasiaPhase 4NCT05274672
Role of Prophylactic Postoperative Antibiotics in HoLEP
A Phase 4 study testing Nitrofurantoin, Cephalexin and Sulfamethoxazole Trimethoprim Combination in people with Benign Prostatic Hyperplasia and Urinary Tract Infections, run by Baylor Research Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Urinary Tract Infections
- What is being tested?
- Nitrofurantoin, Cephalexin and Sulfamethoxazole Trimethoprim Combination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2023to 20 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men > 40 years old with moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
- Patient with negative preoperative urine culture.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Einstein Healthcare network
Philadelphia, Pennsylvania, 19141
Baylor Scott and White
Temple, Texas, 76508
About this study
Official title: Does Post-operative Antibiotic Prophylaxis Reduce Urinary Tract Infection Rates After Holmium Laser Enucleation of Prostate? a Prospective Randomized Multi-center Study
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.
Read the 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.
- 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.
- 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.
- Being tested
- Nitrofurantoin, Cephalexin, Sulfamethoxazole Trimethoprim Combination, Ciprofloxacin, Holmium Laser Enucleation of prostate
- Keywords
- HoLEP, Prophylactic antibiotics, Urinary tract infection
- Medical subject headings
- Prostatic Hyperplasia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Also called Macrobid
Prophylactic postoperative antibiotic use
CephalexinDrug
Also called Keflex
Prophylactic postoperative antibiotic use
Sulfamethoxazole Trimethoprim CombinationDrug
Also called BACTRIM
Prophylactic postoperative antibiotic use
CiprofloxacinDrug
Also called Cipro
Prophylactic postoperative antibiotic use
Holmium Laser Enucleation of prostateProcedure or surgery
Also called HoLEP
Endoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue
| Study group | Role | What they receive |
|---|---|---|
| Patients not receiving postoperative antibiotics | Experimental | Patients who will not receive prophylactic postoperative antibiotics after HoLEP. Receives: Procedure: Holmium Laser Enucleation of prostate |
| Patients receiving postoperative antibiotics | Active comparator | Patients who will receive3 days prophylactic postoperative antibiotics after HoLEP. Receives: Drug: Nitrofurantoin; Drug: Cephalexin; Drug: Sulfamethoxazole Trimethoprim Combination; Drug: Ciprofloxacin; Procedure: Holmium Laser Enucleation of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: within 30 days after HoLEP
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Mar 2023 (estimated)
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Why it stopped: Lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein Healthcare Network
- Responsible party
- Sponsor
- Investigators
- Marawan M. El Tayeb, MD, Principal investigator, Baylor Scott and White Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274672
- Sponsor's protocol ID
- 022-046
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All the published material will keep human information in an unidentifiable manner.
Publications
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.
PubMed 37592645Lightner 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.
PubMed 31441676Ivan 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.
PubMed 30145652Das 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.
PubMed 31481144Ishikawa 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.
PubMed 22089150Davuluri 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.
PubMed 32777364
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Post-operative Antibiotic Prophylaxis Reduce Urinary Tract Infection Rates After Holmium Laser Enucleation of Prostate? a Prospective Randomized Multi-center Study
- ClinicalTrials.gov ID
- NCT05274672
- Acronym / sponsor ID
- 022-046
- Keywords
- HoLEP, Prophylactic antibiotics, Urinary tract infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Albert Einstein Healthcare Network
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients not receiving postoperative antibiotics | Experimental | Procedure: Holmium Laser Enucleation of prostatePatients who will not receive prophylactic postoperative antibiotics after HoLEP. |
| Patients receiving postoperative antibiotics | Active comparator | Drug: Nitrofurantoin, Drug: Cephalexin, Drug: Sulfamethoxazole Trimethoprim Combination, Drug: Ciprofloxacin, Procedure: Holmium Laser Enucleation of prostatePatients who will receive3 days prophylactic postoperative antibiotics after HoLEP. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men > 40 years old with moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
- Patient with negative preoperative urine culture.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitrofurantoinAlso: MacrobidProphylactic postoperative antibiotic use | Drug | Patients receiving postoperative antibiotics |
| CephalexinAlso: KeflexProphylactic postoperative antibiotic use | Drug | Patients receiving postoperative antibiotics |
| Sulfamethoxazole Trimethoprim CombinationAlso: BACTRIMProphylactic postoperative antibiotic use | Drug | Patients receiving postoperative antibiotics |
| CiprofloxacinAlso: CiproProphylactic postoperative antibiotic use | Drug | Patients receiving postoperative antibiotics |
| Holmium Laser Enucleation of prostateAlso: HoLEPEndoscopic transurethral Holmium Laser enucleation of enlarged prostate followed by morcellation of prostatic tissue | Procedure or surgery | Patients not receiving postoperative antibiotics, Patients receiving postoperative antibiotics |
Primary outcome
the rates of urinary tract infection within the 30-day post-operative period after HoLEP
Time frame: within 30 days after HoLEP
A urinary tract infection is defined as a positive urine culture .
1 secondary outcome
The incidence of irritative voiding symptoms after HoLEP and all the other urinary functional outcomes.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 37592645Tennyson 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.
- Background: PubMed 31441676Lightner 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.
- Background: PubMed 30145652Ivan 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.
- Background: PubMed 31481144Das 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.
- Background: PubMed 22089150Ishikawa 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.
- Background: PubMed 32777364Davuluri 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.
- Individual participant dataSharing planned: No. All the published material will keep human information in an unidentifiable manner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marawan M. El Tayeb, MD principal investigator
Baylor Scott and White Health Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrofurantoin, Cephalexin and Sulfamethoxazole Trimethoprim Combination in people with Benign Prostatic Hyperplasia and Urinary Tract Infections, run by Baylor Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rates of urinary tract infection within the 30-day post-operative period after HoLEP (time frame: within 30 days after HoLEP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274672, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.