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Study on Overactive Bladder Treatment for Women Using Clostridium Botulinum Neurotoxin Type A and Vibe System

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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 overactive bladder (OAB) in women. Overactive bladder is a condition characterized by a sudden, strong need to urinate, which can lead to involuntary leakage of urine. The treatment being tested in this study is called Xeomin, which contains a substance known as Clostridium botulinum neurotoxin type A. This substance is commonly used to relax muscles and is being explored for its potential to help manage symptoms of overactive bladder.

The study aims to assess the safety and initial effectiveness of a new method of administering Xeomin using the Vibe System. The Vibe System is a special device designed to deliver the medication directly to the bladder wall without the use of needles, which may reduce discomfort compared to traditional injections. Participants in the study will receive either Xeomin or a placebo, and the treatment will be administered using the Vibe System. The study will gather feedback from both patients and doctors to evaluate the ease of use and satisfaction with the treatment method.

Throughout the study, participants will be monitored for any side effects and changes in their symptoms. The study will last for a period of several weeks, during which participants will be asked to keep a diary of their urinary symptoms and attend follow-up visits to assess the treatment's impact. The goal is to determine if this new approach can provide a safe and effective option for managing overactive bladder symptoms in women.

The research process

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

Step 1
Initial visit
Upon joining the study, you will attend an initial visit where you will be asked to provide informed consent. This means you agree to participate after understanding the study details.
During this visit, you will undergo a pregnancy test if applicable, and your medical history will be reviewed to confirm your eligibility.
Step 2
Baseline assessment
You will be asked to maintain a voiding diary for three consecutive days. This involves recording the number of times you urinate and any episodes of urgency or leakage.
This information helps establish a baseline to compare changes during the study.
Step 3
Treatment administration
You will receive an intravesical administration of Xeomin or a placebo. Intravesical means the medication is delivered directly into the bladder.
The treatment aims to assess the safety and initial effectiveness of the medication for overactive bladder symptoms.
Step 4
Post-treatment follow-up
After treatment, you will be monitored for any adverse events related to the drug or device used. This monitoring will continue for up to 12 weeks.
You will be asked to complete questionnaires about your experience and satisfaction with the treatment.
Step 5
Follow-up assessments
At 6 and 12 weeks post-treatment, you will again maintain a voiding diary for three consecutive days to track changes in your symptoms.
These assessments will help determine the effectiveness of the treatment in reducing symptoms such as urgency, frequency, and leakage.
Step 6
Final evaluation
At the end of the study period, a final evaluation will be conducted to assess the overall impact of the treatment on your overactive bladder symptoms.
You will be asked to provide feedback on your experience throughout the study.

Who can join the trial?

10 criteria

Must be a female aged between 18 and 80 years at the time of signing the consent form.
If you can have children, you must have a negative pregnancy test and use a reliable method of birth control from at least 4 weeks before treatment until 12 weeks after treatment.
Must provide written consent to participate in the study.
Must have been diagnosed with overactive bladder (OAB) for at least 6 months before the screening, as shown by your medical history.
Must have at least 8 urination episodes per day based on a diary kept for 3 consecutive days during screening.
Must have OAB with at least 6 leaking episodes associated with urgency, shown in a 3-day diary, with at least one episode per day.
Must be mentally competent and able to understand and follow the study requirements.
Must be willing and able to self-catheterize after treatment, if needed. (Self-catheterization means inserting a thin tube into the bladder to help empty it.)
Must have had an inadequate response to conservative medication treatments, as determined by the study doctor.
Must agree to attend all follow-up evaluations and be willing and able to complete diaries and questionnaires accurately, and to complete required exams and tests.

Who cannot join the trial?

3 criteria

Patients who are not female cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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

Verified
Centro Hospitalar E Universitario De Coimbra E.P.E.
Coimbra, Portugal
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Centro Hospitalar Universitario Sao Joao E.P.E.
Porto, Portugal
Verified
Unidade Local De Saúde De Santa Maria, E.P.E.
Lisbon, Portugal

Trial locations

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Investigated drugs

XEOMIN®
is a medication used in this clinical trial to help treat women with a condition called idiopathic overactive bladder (OAB). This condition causes a sudden urge to urinate that can be difficult to control. XEOMIN® is a type of botulinum toxin, which works by relaxing the muscles in the bladder. This relaxation can help reduce the symptoms of OAB, such as frequent urination and urgency. In this trial, XEOMIN® is administered directly into the bladder to see if it can safely and effectively help manage these symptoms.
Vibe System
is a device used in combination with XEOMIN® in this clinical trial. The Vibe System is designed to help deliver the medication directly into the bladder. This system is being tested to see how easy it is for both doctors and patients to use, and to gather feedback on the overall experience. The goal is to ensure that the Vibe System is user-friendly and effective in helping administer the treatment for overactive bladder symptoms.

Clostridium Botulinum Neurotoxin Type A (150Kd), Free Of Complexing Proteins

What is already known about the treatment

XEOMIN® – XEOMIN® is administered through a method called intravesical administration, which involves delivering the medication directly into the bladder. Currently, XEOMIN® is being studied in clinical trials for its potential use in treating overactive bladder (OAB) in women. The main therapeutic indication for XEOMIN® in this trial is to help manage symptoms of idiopathic overactive bladder, which includes frequent urination and urgency. At the molecular level, XEOMIN® works by blocking the release of certain chemicals in the nerves that cause muscle contractions, helping to relax the bladder muscles. It is classified pharmacologically as a neurotoxin, specifically a botulinum toxin type A, which is commonly used to reduce muscle activity.

Investigated diseases

Overactive Bladder (OAB) – Overactive bladder is a condition characterized by a sudden, involuntary contraction of the muscle in the wall of the urinary bladder. This leads to a sudden and urgent need to urinate, which can be difficult to control. The condition often results in frequent urination, including waking up multiple times at night to urinate, known as nocturia. It may also cause urgency urinary incontinence, where there is an involuntary loss of urine immediately following an urgent need to urinate. The symptoms can vary in intensity and may fluctuate over time. Overactive bladder is not a normal part of aging, although it is more common in older adults.