Overactive Bladder Treatment with Xeomin and Vibe Delivery System (XAVIER)

Phase 1

• Conditions: Overactive bladder (OAB); MedDRA version: 21.1Level: LLTClassification code: 10059617Term: Overactive bladder Class: 10038359; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2022-501759-95-00
• Lead Sponsor: Vensica Medical Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study Completion: 2024-02-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified