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Safety and Efficacy of Intravesical Clostridium botulinum Neurotoxin Type A (150 kD) for Idiopathic Overactive Bladder in Women

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What is this trial about?

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

The study focuses on Idiopathic Overactive Bladder, a condition in which the bladder contracts suddenly, causing a strong urge to urinate and occasional leakage. The investigational product is a purified form of clostridium botulinum neurotoxin type a (150kd), free of complexing proteins that is delivered directly into the bladder (intravesical administration) using a device called the Vibe System. A matching placebo that looks the same as the active product is also used for comparison.

The aim of the trial is to find out whether this combination is safe and works better than the placebo for reducing Urinary Incontinence and the feeling of sudden urgency in women with the condition. Participants are randomly assigned to receive either the active drug or the placebo, the treatment is given once through the Vibe System, and they are asked to keep a short diary of bladder episodes for about three months while researchers monitor any side effects and overall quality of life using a questionnaire called I-QOL.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You sign the consent form and are officially entered into the study.

    Your eligibility is confirmed and you receive a brief overview of what will happen during the trial.

  2. Step 2

    Baseline Diary Recording

    You complete a 3‑day diary that records each episode of urinary incontinence you experience before any treatment is given.

    The information collected will be used as the reference point for later comparisons.

  3. Step 3

    Randomization and Preparation for Treatment

    You are randomly assigned to receive either the active medication or a placebo that looks identical.

    Study staff prepare the medication for delivery using the Vibe System, a device that administers the product directly into the bladder.

  4. Step 4

    Intravesical Administration of Study Medication

    A thin tube is inserted into your bladder, and a single dose of 300 U (units) of clostridium botulinum neurotoxin type a (150 kD) is delivered if you are in the active group.

    If you are in the placebo group, the same volume of an inert solution is delivered in exactly the same way.

    The medication is given only once during the trial.

  5. Step 5

    Post‑Treatment Observation

    You remain in the clinic for a short observation period while staff monitor you for any immediate reactions.

    No additional medication is given during this time.

  6. Step 6

    Continued Diary Completion

    You continue to record your urinary symptoms in 3‑day diary entries at scheduled intervals, typically before each follow‑up visit.

    These entries help assess changes in the number of incontinence and urgency episodes.

  7. Step 7

    Follow‑Up Visits

    You attend clinic visits approximately 4 weeks, 8 weeks, and 12 weeks after the treatment.

    During each visit, staff check your safety, review your diary entries, and ask you to complete questionnaires about bladder symptoms and quality of life.

  8. Step 8

    Final Evaluation at 12 Weeks

    At the 12‑week visit, the study team collects the final 3‑day diary and the quality‑of‑life questionnaire.

    They compare the data to the baseline values to determine any change in the frequency of urinary incontinence and urgency episodes.

  9. Step 9

    End of Study Participation

    After the final assessment, your involvement in the trial is complete.

    You receive a summary of the study results and any relevant information about your health.

Who can join the trial?

11 criteria

  • Signed written informed consent – you must sign a form that shows you understand the study and agree to take part.
  • If you are taking tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) or serotonin‑norepinephrine reuptake inhibitors (SNRIs), you need to have been on the same dose for at least 3 months before joining and stay on that same dose until the 12‑week follow‑up visit.
  • If you could become pregnant, you must have a negative pregnancy test at the screening visit and use a reliable method of birth control (one that fails less than 1 % of the time each year) during the study and for 3 months after it ends.
  • You must be a female aged between 18 and 80 years old.
  • You must have a documented diagnosis of idiopathic overactive bladder (OAB) (bladder problems that are not caused by another disease) for at least 6 months before joining the study.
  • You need to record at least an average of 8 times per day you go to the bathroom to empty your bladder, based on a 3‑day diary you keep.
  • You need to record at least 5 episodes of urinary incontinence (leaking urine) during the same 3‑day diary, with at least one episode each day.
  • You must be able to understand the study instructions and follow the required procedures.
  • You must be willing and able to start self‑catheterization (inserting a thin tube into the bladder to drain urine) after treatment if the doctor says it is needed.
  • You must agree to attend all follow‑up visits, fill out the bathroom‑use diaries and questionnaires, and complete any required exams or tests.
  • If you are taking antimuscarinic medicines or beta‑3 adrenergic agonist medicines for bladder control, you need to have been on a stable dose for at least 1 month before screening and stay on that same dose until the 12‑week follow‑up visit.

Who cannot join the trial?

18 criteria

  • Having trouble emptying the bladder or leaving more than 150 ml of urine after peeing (called a high post‑void residual) during screening.
  • Being pregnant or breastfeeding.
  • Having a known problem in the pelvic or urinary area that the doctor thinks could affect the study.
  • Having an overactive bladder that is caused by a neurological condition such as Myasthenia Gravis, ALS, Lambert‑Eaton syndrome, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, or a stroke.
  • Having a current or past neuromuscular disorder (a disease that affects the nerves and muscles) such as Myasthenia Gravis, Lambert‑Eaton syndrome, or ALS.
  • Having a history of polyuria (excessive urination) or polydipsia (excessive thirst).
  • Having been diagnosed with a very small bladder that can hold 100 ml or less.
  • Changing the use of diuretic medicines (drugs that make you urinate more) in the last three months.
  • Having a known bladder outlet obstruction (a blockage that prevents urine from leaving the bladder easily).
  • Taking or planning to take medicines that interfere with nerve‑to‑muscle signals, such as certain antibiotics (aminoglycosides, polypeptide antibiotics, lincomycin), aminoquinolines, or muscle relaxants like tubocurarine.
  • Having a current or past recurring urinary tract infection (three or more infections in the last six months), a urinary fistula (abnormal connection), or a blockage such as cancer, a urethral stricture, or a urinary stone.
  • Having received botulinum toxin injections for any reason in the past nine months.
  • Having had neurostimulation treatment for overactive bladder in the past six months.
  • Being in active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the last four weeks (self‑performed Kegel exercises are allowed).
  • Not responding to a previous botulinum toxin treatment for overactive bladder.
  • Having a known allergy to any type of botulinum toxin.
  • Having a known allergy to polyurethane (a type of plastic material).
  • Having more than a minimal amount of stress incontinence (leakage when coughing, sneezing, or exercising) or mixed incontinence where the stress component is strong enough to affect study results, as shown in a three‑day bladder diary or questionnaire.
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Investigated drugs

Botulinum toxin type A (free of complexing proteins) is a purified protein that temporarily relaxes the muscles in the bladder. In this trial it is placed directly into the bladder (intravesical use) to help reduce the urge to urinate and improve bladder control in women with overactive bladder. The medication works by blocking nerve signals that cause the bladder muscle to contract too often.

The Vibe System is a special medical device used to deliver the botulinum toxin into the bladder. It gently introduces the medication through a catheter, ensuring the drug reaches the bladder lining where it can act. The system is designed to be safe and comfortable for the patient while providing accurate dosing during the trial.

What is already known about the treatment

CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS - The drug is given directly into the bladder using a small catheter and the Vibe delivery system. It is an experimental formulation of botulinum toxin type A that is still being studied in clinical trials and is not yet approved for this use. It is being tested to help women with overactive bladder who have trouble controlling urine leakage. The toxin works by blocking a chemical signal that tells bladder muscles to contract, which reduces unwanted bladder activity, and it belongs to the class of neuromuscular‑blocking neurotoxins.

Investigated diseases

Idiopathic Overactive Bladder - It is a condition marked by an urgent need to urinate that occurs without an obvious cause. The bladder contracts more often than normal, leading to frequent daytime urination and sometimes waking at night to void. People may experience sudden urges that are difficult to postpone, which can result in involuntary leakage. Over time, the frequency and intensity of urges may increase, and episodes of urgency urinary incontinence can become more common. The symptoms tend to persist or gradually worsen if the underlying bladder activity remains uncontrolled.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526512-36-00Protocol codeViXe-CLP-003Estimated enrolment260 patientsSponsorVensica Medical Ltd.

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