An Exploratory, Prospective, Multicenter, Randomized, Double Blind, Placebo + Sham Device Controlled, Study to Assess the Safety, Usability, and Initial Efficacy of the ViXe Combination for Intravesical Administration of XEOMIN® in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Vensica Therapeutics Ltd.
- Enrollment
- 48
- Locations
- 8
- Primary Endpoint
- Adverse Events Rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question[s] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female aged between 18 and 80 years at the time of signing the informed consent.
- •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), and at least one episode per day demonstrated on 3-consecutive days voiding diary.
- •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.
- •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
Exclusion Criteria
- •Previous participation in another study with any investigational drug or device within the past 90 days.
- •Allergy to Botulinum neurotoxin type A or any of the other ingredients and components of this device or the drug
- •Subject with OAB caused by neurological conditions (i.e., Myasthenia Gravis, ALS, Eaton-Lambert Syndrome, etc.)
- •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.
- •Subject with PVR ≥ 200 ml based on bladder ultrasound at screening visit.
Outcomes
Primary Outcomes
Adverse Events Rate
Time Frame: 12 weeks
Incidence of drug and device related adverse events from treatment to 12-weeks post treatment
Usability and ease-of-use perception by investigator, subject and technician
Time Frame: Procedure
Satisfaction of investigator, participant and technicain from the treatment, as assessed by the sponsor designed usability questionnaire. Investigator's questionnaire consists of 43 questions on a scale of 1-7 each (total range 43-301). The higher the total score, the better the investigator satisfaction. Subject usability questionnaire consists of 11 questions on a scale of 0-10 (total range 0-110). Thr higher the score, the more statisfied the subject from the treatment. Technician's questionnaire consists of yes/no questions only.
Secondary Outcomes
- Urinary Urgency(12 weeks)
- Daily Urgency Urinary Incontinence(12 weeks)
- Nocturia(12 weeks)
- Total Daily Episodes(12 weeks)
- Voiding Leaks(12 weeks)
- Quality of Life Queationnsaire(12 weeks)