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Testing Antibiotic Treatment Strategies for Patients with Bladder Bacteria Without Symptoms Receiving Botulinum Toxin A Bladder Injections

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study involves patients who have multiple sclerosis or spinal cord injury and are experiencing bladder problems due to overactive bladder muscle, which is a condition where the bladder muscle contracts uncontrollably, leading to urinary incontinence. These patients use a technique called clean intermittent self-catheterization, which means they insert a thin tube into their bladder several times a day to empty it. The study focuses on patients who have bacteria in their urine without experiencing any symptoms, which is called asymptomatic bacteriuria, and who are scheduled to receive injections of botulinum toxin A directly into the bladder to help control the overactive bladder. The medications being studied in this trial include various antibiotics such as amoxicillin, ofloxacin, ceftriaxone, levofloxacin, clavulanic acid, aztreonam, pivmecillinam hydrochloride, trimethoprim, ciprofloxacin, sulfamethoxazole, fosfomycin trometamol, and cefixime.

The purpose of this study is to compare two different approaches to managing the bacteria in the urine before the botulinum toxin injection. One approach involves giving antibiotics around the time of the injection, which is the current standard practice, while the other approach avoids giving antibiotics unless symptoms develop later. The study aims to determine whether avoiding antibiotics initially is just as safe and effective as the standard approach in preventing urinary tract infections that cause symptoms after the injection. A urinary tract infection with symptoms would include signs such as fever, pain during urination, or other clear indicators that the infection is causing problems in the body.

During the study, patients will have their urine tested about five days before the scheduled botulinum toxin injection to check for bacteria. Following the injection, they will be monitored for six weeks to see if they develop a symptomatic urinary tract infection. The study will also track other health events, visits to emergency departments, and unplanned hospital admissions during this period. At the six-week mark, patients will undergo bladder function tests and keep a three-day diary recording how often they need to use catheterization, episodes of urgency, and any incontinence episodes. The study will measure various aspects of bladder function, including bladder capacity and pressure, to assess how well the botulinum toxin treatment is working.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Pre-injection urine test

    A urine sample will be collected 5 days before the scheduled bladder injection, with a possible variation of 2 days earlier or later.

    This test checks for the presence of bacteria in the urine without symptoms of infection, a condition called asymptomatic bacteriuria.

  2. Step 2

    Assignment to treatment group

    Based on the urine test results, a treatment approach will be determined for managing bacteria found in the urine.

    One approach involves receiving antibiotics around the time of the injection, while the other approach avoids routine antibiotic use unless symptoms develop.

    The assignment to either approach is done randomly to compare their effectiveness.

  3. Step 3

    Bladder injection procedure

    The scheduled injection of botulinum toxin A into the bladder will be performed as planned.

    This injection is given directly into the bladder wall through a scope to help manage overactive bladder symptoms.

    The procedure is performed as part of the ongoing treatment, not specifically for the study.

  4. Step 4

    Antibiotic administration (if assigned)

    If assigned to the antibiotic approach, medication will be given around the time of the injection procedure.

    The antibiotics that may be used include various options taken by mouth or given by injection, depending on the bacteria found and individual medical factors.

    Possible antibiotics include: amoxicillin, amoxicillin with clavulanic acid, ofloxacin, levofloxacin, ciprofloxacin, ceftriaxone, cefixime, aztreonam, pivmecillinam, trimethoprim, sulfamethoxazole with trimethoprim, or fosfomycin.

    The specific antibiotic, dose, and duration will be determined based on individual circumstances and the type of bacteria present.

  5. Step 5

    Monitoring period for symptoms

    A 6-week monitoring period begins immediately after the injection procedure.

    During this time, attention should be paid to any signs of urinary tract infection, such as fever, increased urinary urgency, pain during urination, cloudy or foul-smelling urine, or worsening incontinence.

    Any symptoms that develop should be reported to the medical team for evaluation and possible treatment.

  6. Step 6

    Bladder diary completion

    At 6 weeks after the injection, a 3-day bladder diary will need to be completed.

    This diary records the number of times self-catheterization is performed each day, episodes of urgent need to urinate, episodes of urine leakage, and the volume of urine collected during catheterization.

    This information helps assess how well the bladder injection is working.

  7. Step 7

    Follow-up bladder function test

    At 6 weeks after the injection, a bladder function test called urodynamic study will be performed.

    This test measures how much the bladder can hold, whether involuntary bladder contractions occur during filling, and the pressure inside the bladder.

    The test involves filling the bladder with fluid through a catheter while measuring pressures and sensations.

  8. Step 8

    Reporting of health events

    Throughout the 6-week period, any unexpected health problems, visits to emergency departments, or unplanned hospital admissions should be reported.

    This includes both events that may be related to the bladder injection and those that are unrelated.

    Regular communication through the provided electronic means will be used to collect this information.

Who can join the trial?

7 criteria

  • You must be 18 years of age or older, either male or female
  • You must have been diagnosed with Multiple Sclerosis (a disease affecting the brain and spinal cord) or Spinal Cord Injury (damage to the spinal cord from trauma or other causes)
  • You must use Clean Intermittent Self-Catheterization as your only method of emptying your bladder (this means you use a thin tube to drain urine from your bladder several times a day)
  • You must have Refractory Detrusor Overactivity (a bladder muscle problem that causes leakage of urine) that has not improved with standard medications, or you cannot tolerate these medications, or you are not allowed to take them for medical reasons
  • You must have previously received intra-vesical BoNTA injections (injections of botulinum toxin directly into the bladder wall) that have worked well for you
  • You must have Asymptomatic Bacteriuria (bacteria present in your urine without causing symptoms like pain or fever) shown on a urine test performed 5 days before your scheduled injection (the test can be done 2 days earlier or later)
  • You must have a personal email address that you use regularly, access to the internet most of the time, and a mobile phone

Who cannot join the trial?

5 criteria

  • Patients younger than 18 years old cannot participate in this study
  • Patients who do not have detrusor overactivity, which means involuntary contractions of the bladder muscle that cause urgent need to urinate, cannot participate
  • Patients whose detrusor overactivity is not caused by multiple sclerosis, a disease affecting the brain and spinal cord, or spinal cord injury, which is damage to the spinal cord, cannot participate
  • Patients who do not perform clean intermittent self-catheterization, a method where a thin tube is inserted into the bladder several times a day to empty urine, cannot participate
  • Patients who do not have asymptomatic bacteriuria, which means bacteria in the urine without any symptoms of infection, cannot participate
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Investigated drugs

  • Botulinum toxin A

    is a medication that is injected directly into the bladder wall. It works by relaxing the bladder muscle, which can help people who have problems with their bladder not working properly. This treatment is commonly used for patients who have trouble controlling their bladder due to conditions affecting their nerves or spinal cord.

  • Antibiotics

    are medications that fight bacterial infections in the body. In this trial, antibiotics are being given around the time of the bladder injection procedure to see if they help prevent urinary tract infections. The study is comparing two different approaches: one where antibiotics are given as a preventive measure during the procedure, and another approach that uses antibiotics more sparingly.

What is already known about the treatment

Botulinum Toxin A – Botulinum Toxin A is a medication injected directly into the bladder wall (intra-vesical injection) to treat overactive bladder muscles in patients with multiple sclerosis or spinal cord injuries. It works by blocking the release of a chemical messenger called acetylcholine at the nerve endings, which temporarily relaxes the bladder muscle and reduces involuntary contractions. This treatment is an established option in modern medicine for patients who have not responded well to other medications for bladder control problems. The injection procedure is performed by a healthcare professional during a medical visit, and its effects typically last several months before repeat treatment may be needed.

Investigated diseases

  • Multiple Sclerosis

    Multiple sclerosis is a chronic disease of the central nervous system in which the immune system attacks the protective covering of nerve fibers. This damage disrupts communication between the brain and the rest of the body. The disease can cause various symptoms including problems with vision, arm or leg movement, sensation, and balance. Multiple sclerosis often progresses in episodes of worsening symptoms followed by periods of partial or complete recovery. Over time, some people may experience a gradual worsening of symptoms without distinct recovery periods. The specific symptoms and rate of progression vary greatly from person to person.

  • Spinal Cord Injury

    Spinal cord injury refers to damage to the spinal cord that results in temporary or permanent changes in its function. The injury disrupts signals between the brain and the body, affecting movement, sensation, and other body functions below the level of injury. Depending on the location and severity of the damage, a person may experience partial or complete loss of muscle function and sensation. Spinal cord injury can also affect control of the bladder and bowel. The initial injury may worsen over days or weeks due to bleeding, swelling, and fluid accumulation in and around the spinal cord. After the initial phase, the condition typically stabilizes, though some improvement in function may occur over time.

  • Detrusor Overactivity

    Detrusor overactivity is a condition characterized by involuntary contractions of the bladder muscle during the filling phase of the bladder cycle. These uncontrolled contractions occur even when the bladder is not full, creating a sudden and strong urge to urinate. The condition can result in frequent urination, urgent need to urinate, and involuntary loss of urine. Detrusor overactivity commonly occurs in people with neurological conditions such as multiple sclerosis or spinal cord injury. The involuntary bladder contractions happen because the normal nerve signals that control bladder function are disrupted. This condition significantly affects daily activities and quality of life due to unpredictable bladder behavior.

  • Asymptomatic Bacteriuria

    Asymptomatic bacteriuria is the presence of bacteria in the urine without any signs or symptoms of a urinary tract infection. People with this condition have significant numbers of bacteria in their urine but do not experience pain, burning, fever, or other typical infection symptoms. It is particularly common in individuals who use intermittent catheterization to empty their bladder. The bacteria colonize the urinary tract but do not cause tissue invasion or an immune response. Asymptomatic bacteriuria can persist for extended periods without causing any noticeable problems. In certain populations, particularly those with neurological conditions affecting bladder function, this condition is very frequent.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515107-19-00Protocol codeDRI_2020/03Estimated enrolment526 patientsSponsorCentre Hospitalier Universitaire De Lille

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