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Overactive Bladder Treatment with Xeomin and Vibe Delivery System (XAVIER)
EU CTIS ID: 2022-501759-95-00
What this study is testing
To demonstrate the Safety of ViXe combination and to investigate the usability, ease of use and patient satisfaction of the Vibe System and receive structured feedback from physician and patient.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female aged between 18 and 80 years at the time of signing the informed consent.
- Females with childbearing potential must have a negative pregnancy test and must practice an acceptable method of birth control, from at least 4 weeks before treatment until 12 weeks after treatment.
- Signed written informed consent.
- Diagnosis of OAB for at least 6 months prior to screening, determined by documented subject history.
- At least 8 voiding episodes/day based on 3-consecutive days voiding diary at screening.
- OAB with at least 6 leaking episodes associated with urgency (UUI), demonstrated on 3-consecutive days voiding diary, and at least one episode per day.
You likely can't join if
- Previous participation in another study with any investigational drug or device within the past 90 days.
- Subject with PVR ≥ 200 ml based on bladder ultrasound at screening visit.
- Current or recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula per physical examination, or known significant urinary tract obstruction or urethral stricture.
- Subject who received botulinum toxin injections within the past 8 months for any indication and in any body part.
- Subject with predominant stress incontinence based on MESA incontinence score and/or voiding diary at screening.
- BMI ≥ 35 kg/m2.
See the full eligibility criteria
Who can join
- Female aged between 18 and 80 years at the time of signing the informed consent.
- Females with childbearing potential must have a negative pregnancy test and must practice an acceptable method of birth control, from at least 4 weeks before treatment until 12 weeks after treatment.
- Signed written informed consent.
- Diagnosis of OAB for at least 6 months prior to screening, determined by documented subject history.
- At least 8 voiding episodes/day based on 3-consecutive days voiding diary at screening.
- OAB with at least 6 leaking episodes associated with urgency (UUI), demonstrated on 3-consecutive days voiding diary, and at least one episode per day.
- Subject is mentally competent with the ability to understand and comply with the requirements of the study.
- Subject is willing and able to initiate self-catheterization post treatment, if required.
- Subject with inadequate response to conservative medication treatment/s as defined by the investigator.
- Subject agrees to attend all follow-up evaluations and is willing and capable to fill out voiding diaries and questionnaires completely and accurately and is willing to complete required exams and tests.
What rules you out
- Previous participation in another study with any investigational drug or device within the past 90 days.
- Subject with PVR ≥ 200 ml based on bladder ultrasound at screening visit.
- Current or recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula per physical examination, or known significant urinary tract obstruction or urethral stricture.
- Subject who received botulinum toxin injections within the past 8 months for any indication and in any body part.
- Subject with predominant stress incontinence based on MESA incontinence score and/or voiding diary at screening.
- BMI ≥ 35 kg/m2.
- If used should be on stable doses of diuretics for the past 3 months.
- Subjects who have any implanted electronic devices (a pacemaker, for example), permanent or transient, that cannot be removed prior to the treatment.
- Subjects who have received tibial or sacral nerve stimulation (SNS) anytime in the past or percutaneous tibial nerve (PTNS) in the last 3 months.
- Previous urinary incontinence surgery or prolapse surgery or de novo urinary incontinence post-surgery within the last 12 months.
- Any spinal surgery within the last 12 months.
- Allergy to Botulinum neurotoxin type A or any of the other ingredients and components of this device or the drug
- Previous abdominoperineal resection of the rectum or previous radical hysterectomy.
- Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines.
- History of evidence of anatomic pelvic, urological or urogenital abnormality according to investigator’s discretion.
- If used, subjects should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 3 months prior to enrolment and agree to remain on stable medication consumption until the 12-weeks follow-up visit.
- If used, subjects should be on a stable dose of tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 months prior to enrolment and agree to remain on stable medication consumption until the 12 weeks follow-up visit.
- Subject with abnormal renal function defined by estimated glomerular filtration rate (eGFR) of 30 ml/min or less.
- History of pelvic radiotherapy or chemotherapy for pelvic malignancies.
- Diabetes with peripheral nerve neuropathy or severe uncontrolled diabetes (with HbA1C > 7.5%).
- Uterine prolapse, cystocele, enterocele or rectocele past the hymen.
- Deemed unsuitable for enrollment by the investigator based on history or physical examination.
- Subject with OAB caused by neurological conditions (i.e., Myasthenia Gravis, ALS, Eaton-Lambert Syndrome, etc.)
- Any psychiatric or personality disorder at the discretion of the study physician.
- Any severe or uncontrolled systemic disease (e.g., cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection, or any findings from laboratory or physical examination performed at screening at the discretion of the investigator
- Subject is breastfeeding.
- Drug or alcohol abuse
- Any neurological disease or disorder including Alzheimer’s, Parkinson, MS, stroke (CVA), neuropathy or injury resulting in neuropathy.
- Subject currently under treatment with biofeedback, pelvic muscle rehabilitation, pelvic floor physical therapy. If willing to discontinue will be allowed to participate after 4 weeks of wash out. Self-Kegels exercises are allowed.
- Bleeding disorders or treatment with anticoagulants, antiplatelet (except acetylsalicylic acid), or thrombolytic medications within 14 days prior to screening.
- Subjects with compromised respiratory function or dysphagia.
- Current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines)
- Subject with known polyuria/polydipsia with 24-hour total volume void > 3000 ml.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.