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).

Trial ID: 2022-501759-95-00
Protocol: ViXe-CLP-0002
Sponsor: Vensica Medical Ltd.

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Diseases & Conditions

Hypertonic bladder

Objectives

The primary objective of this study is to **demonstrate the safety** of the ViXe combination, which involves the intravesical administration of XEOMIN® for the treatment of female patients with idiopathic **overactive bladder (OAB)**. Additionally, the study aims to investigate the usability, ease of use, and patient satisfaction with the Vibe System, while also gathering structured feedback from both physicians and patients. The clinical relevance of this objective lies in ensuring that the ViXe combination is a safe and user-friendly treatment option for OAB, potentially improving patient outcomes and satisfaction.

The secondary objective is to investigate the initial efficacy of the ViXe combination. This aspect of the study is crucial for determining the potential therapeutic benefits of the treatment, which could lead to improved management of OAB symptoms in the target patient population.

Participants

The clinical trial focuses on evaluating the safety and usability of the ViXe combination for **overactive bladder (OAB)**. The study population consists exclusively of female participants, aged between 18 and 80 years. Participants are required to have a documented history of OAB for at least six months prior to screening, with a minimum of eight voiding episodes per day and at least six leaking episodes associated with urgency, as recorded in a voiding diary over three consecutive days. The trial does not include male subjects, and the sponsor has not provided the total number of participants. Participants must be mentally competent, able to comply with study requirements, and willing to initiate self-catheterization post-treatment if necessary. The trial population was selected based on specific inclusion criteria, including a negative pregnancy test for females of childbearing potential and an inadequate response to conservative medication treatments. The sponsor has not disclosed any additional lifestyle considerations or specific health status requirements for the participants.

Plans and Procedures

The clinical trial is designed as a **randomized**, **double-blind**, placebo and sham device-controlled study to evaluate the safety, usability, and initial efficacy of the ViXe combination for the intravesical administration of **Xeomin** in female patients with idiopathic **overactive bladder** (OAB). The trial is set to run from April 3, 2023, to January 31, 2024, with an estimated duration of approximately 10 months. Participants will be involved in the study for a period of up to 12 weeks post-treatment.

The trial will commence with a screening visit to confirm eligibility based on specific inclusion criteria, such as age, diagnosis of OAB, and the ability to comply with study requirements. Following successful screening, participants will be randomized to receive either the active treatment or placebo. The study involves multiple follow-up visits to monitor safety and efficacy, with primary endpoints focusing on the incidence of drug and device-related adverse events and usability feedback from physicians, subjects, and technicians. Secondary endpoints include changes in the frequency of urinary incontinence episodes and voiding episodes, assessed at 6 and 12 weeks post-treatment.

Participants are expected to attend all scheduled visits and complete required assessments, including voiding diaries and questionnaires. The study may terminate early for participants who experience significant adverse events or are unable to comply with study protocols. The trial aims to provide valuable insights into the safety and effectiveness of the ViXe combination in managing symptoms of OAB, contributing to the broader understanding of treatment options for this condition.

Treatment

The clinical trial involves the administration of **Xeomin**, a pharmaceutical product containing **Clostridium botulinum neurotoxin type A (150kD), free of complexing proteins**. This investigational medicinal product is provided in the form of a powder for solution for injection, specifically designed for **intravesical use**. The maximum daily and total dose is 200 units, administered in a single treatment period. The product is manufactured by Merz Pharmaceuticals GmbH and follows the same manufacturing process as the marketed product, with the exception of labeling. The administration is facilitated by the Vibe System, an ultrasound-based, needle-free, intravesical delivery system. This system is designed to deliver the pharmaceutical agent uniformly around the bladder wall, potentially offering better efficacy and reduced pain compared to traditional needle injections.

The study also includes a **placebo** control, referred to as Xeomin placebo. This placebo is used to maintain the double-blind nature of the trial, ensuring unbiased assessment of the investigational product's efficacy and safety. The placebo does not contain any active substance and is not associated with any specific pharmaceutical form or route of administration. The use of a placebo is critical in distinguishing the actual effects of the investigational product from psychological or other non-specific effects.

Efficacy

Efficacy in this clinical trial will be assessed through several secondary endpoints, focusing on the treatment of female patients with idiopathic overactive bladder (OAB) using the ViXe combination. The primary efficacy parameters include the mean change from baseline in the average number of daily **Urgency Urinary Incontinence (UUI)** episodes, daily voiding episodes, and urinary grade 3 or 4 urgency episodes at 6 and 12 weeks post-treatment. Additionally, the mean change from baseline in the number of large leaks and nocturia episodes will be evaluated at the same time points. These parameters will be measured using a 3-day voiding diary, which participants will complete to provide detailed records of their urinary symptoms.

Furthermore, the change from baseline in the QAB-q total score at week 12 will be assessed to evaluate the impact of the treatment on the quality of life related to bladder symptoms. The collection and analysis of these efficacy parameters will be conducted at specified intervals, specifically at 6 and 12 weeks post-treatment, to determine the initial efficacy of the ViXe combination. The use of validated patient-reported outcomes and structured diaries ensures the reliability and accuracy of the data collected during the trial.

Inclusion and Exclusion Criteria

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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), 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.
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.

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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.
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.
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.
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