Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-07-15

Brief Summary

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To compare the risk of infectious complications (UTI, pyelonephritis, sepsis, hospital admission, ED visits) for patients with an indwelling urinary catheter (urethral or suprapubic) or CIC receiving 3 or 7 days of peri-operative antibiotic prophylaxis at time of Holmium Laser Enucleation of the Prostate

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Detailed Description

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Conditions

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BPH With Urinary Obstruction Antibiotic Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who are eligible to undergo HoLEP and have an indwelling urinary catheter or perform CIC will be randomized to different durations of peri-operative antibiotic prophylaxis

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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3 day prophylaxis

3 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 1 day prior to surgery). macrobid if preoperative culture is negative

Group Type EXPERIMENTAL

antibiotic prophylaxis

Intervention Type DRUG

we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery

7 day prophylaxis

7 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 4 day prior to surgery). macrobid if preoperative culture is negative

Group Type OTHER

antibiotic prophylaxis

Intervention Type DRUG

we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery

Interventions

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antibiotic prophylaxis

we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Candidate for HoLEP surgery 2. Must be 18 years or older. 3. The patient must be able to understand and willing to provide informed consent as described in this study protocol.

Exclusion Criteria

* 1\. Under the age of 18 2. Refuse to provide informed consent 3. Anticipated need for perineal urethrostomy 4. History of multi-drug resistant organism on urine culture that is not susceptible to any oral agents

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No