Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on Antibiotic Treatment Before Surgery for Benign Prostate Hyperplasia: Fosfomycin Calcium, Bromhexine Hydrochloride, Sulfamethoxazole, and Trimethoprim

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Benign Prostate Hyperplasia (BPH), a condition where the prostate gland is enlarged, causing urinary problems. The study will explore the use of antibiotics before undergoing endoscopic surgery for BPH. The antibiotics being studied include Fosfomycin Calcium and a combination of Bromhexine Hydrochloride, Sulfamethoxazole, and Trimethoprim. These medications are commonly used to treat infections and will be compared to a placebo to see if they help reduce the risk of urinary tract infections after surgery.

The purpose of the study is to determine if not using antibiotics before surgery is just as effective as using them in preventing urinary tract infections within one month after the procedure. Participants will be randomly assigned to receive either the antibiotics or a placebo. The study will monitor the occurrence of urinary infections, characterized by symptoms like burning during urination, fever, and urgency, along with the presence of bacteria in the urine.

Throughout the study, researchers will also look at other factors, such as the number of surgeries canceled, the types of bacteria involved, and the costs associated with antibiotic treatment. The study aims to provide insights into whether the experimental approach is both clinically and economically comparable to the standard treatment. This research could potentially influence future prescribing practices for patients undergoing surgery for BPH.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, social security affiliation, and understanding of the study.

    A pre-operative urine culture is performed to identify the presence of three or more pathogens.

  2. Step 2

    Randomization

    Participants are randomly assigned to either receive antibiotics or not before surgery. This is to evaluate the necessity of antibiotics in preventing urinary tract infections post-surgery.

  3. Step 3

    Medication administration

    For those assigned to the antibiotic group, medications such as fosfomycin calcium or a combination of bromhexine hydrochloride, sulfamethoxazole, and trimethoprim are administered orally.

    The dosage and frequency are determined by the study protocol and are aimed at reducing the risk of infection.

  4. Step 4

    Surgery

    Participants undergo scheduled endoscopic surgery for lower urinary tract symptoms related to benign prostate hyperplasia.

    The type of surgery may include procedures like Urolift, Rezum, Aquabeam, or various forms of prostate resection.

  5. Step 5

    Post-operative monitoring

    After surgery, participants are monitored for one month to track the incidence of urinary tract infections.

    Symptoms such as urine burning, fever, and urgency are evaluated by an independent committee.

  6. Step 6

    Data collection and analysis

    Data on infection rates, types of bacteria, and any hospitalizations are collected.

    The study also assesses the economic impact of antibiotic use and the potential for changing prescribing practices.

Who can join the trial?

7 criteria

  • Must be an adult man who is 18 years of age or older.
  • Must be affiliated with a French social security system or an equivalent system.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must be scheduled for surgery to treat lower urinary tract symptoms caused by Benign Prostate Hyperplasia (BPH). This includes procedures like Urolift, Rezum, Aquabeam, monopolar or bipolar transurethral resection of the prostate, enucleation of the prostate (such as Holep, Greenlep, Bipolep), or simple prostatectomy.
  • Must have a polymicrobial pre-operative urine culture, meaning a urine test that shows three or more different types of bacteria.
  • Must be able to follow the study requirements.
  • Must be able to understand the details of this clinical research.

Who cannot join the trial?

2 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not allowed to join the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Antibiotics: These are medications used to treat infections caused by bacteria. In this trial, antibiotics are being evaluated to see if they can help prevent urinary tract infections in patients undergoing surgery for prostate issues. The study aims to determine if not using antibiotics is just as effective as using them in preventing infections after surgery.

What is already known about the treatment

Antibiotics – These medications are typically administered orally or intravenously, depending on the specific type and severity of the infection. In the context of the clinical trial, antibiotics are being evaluated for their use before endoscopic surgery for benign prostate hyperplasia (BPH) when a polymicrobial bacterial culture is present. The trial aims to determine if not using antibiotics is as effective as using them in preventing urinary tract infections after surgery. Antibiotics work by targeting and killing bacteria or inhibiting their growth, helping to clear infections. They are classified as antimicrobial agents and are widely used in medicine to treat bacterial infections.

Investigated diseases

Benign Prostate Hyperplasia – This condition involves the enlargement of the prostate gland, which is common in older men. As the prostate enlarges, it can press against the urethra, leading to difficulties with urination. Symptoms may include a frequent need to urinate, especially at night, a weak urine stream, and the feeling that the bladder is not completely empty after urination. The progression of the disease can vary, with some individuals experiencing a gradual worsening of symptoms over time. In some cases, complications such as urinary tract infections or bladder stones may develop. The condition is not cancerous, but it can significantly impact quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510191-31-00Protocol codeDR230286Estimated enrolment380 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.