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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vensica Medical Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

5 Jun 2023 → 1 Feb 2024

Decision date (initial)

2023-03-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Vensica Medical Ltd.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

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.

Secondary objectives 1

1. To investigate the initial efficacy of ViXe combination.

Conditions and MedDRA coding

Overactive bladder (OAB)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Female aged between 18 and 80 years at the time of signing the informed consent.
2. Signed written informed consent.
3. Diagnosis of OAB for at least 6 months prior to screening, determined by documented subject history.
4. At least 8 voiding episodes/day based on 3-consecutive days voiding diary at screening.
5. 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.
6. Subject is mentally competent with the ability to understand and comply with the requirements of the study.
7. Subject is willing and able to initiate self-catheterization post treatment, if required.
8. Subject with inadequate response to conservative medication treatment/s as defined by the investigator.
9. 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.
10. 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 33

1. Previous participation in another study with any investigational drug or device within the past 90 days.
2. Allergy to Botulinum neurotoxin type A or any of the other ingredients and components of this device or the drug
3. Subject with OAB caused by neurological conditions (i.e., Myasthenia Gravis, ALS, Eaton-Lambert Syndrome, etc.)
4. Any neurological disease or disorder including Alzheimer’s, Parkinson, MS, stroke (CVA), neuropathy or injury resulting in neuropathy.
5. 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.
6. Bleeding disorders or treatment with anticoagulants, antiplatelet (except acetylsalicylic acid), or thrombolytic medications within 14 days prior to screening.
7. Subjects with compromised respiratory function or dysphagia.
8. Current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines)
9. Subject with known polyuria/polydipsia with 24-hour total volume void > 3000 ml.
10. Subject with PVR ≥ 200 ml based on bladder ultrasound at screening visit.
11. 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.
12. Subject who received botulinum toxin injections within the past 8 months for any indication and in any body part.
13. Subject with predominant stress incontinence based on MESA incontinence score and/or voiding diary at screening.
14. BMI ≥ 35 kg/m2.
15. If used should be on stable doses of diuretics for the past 3 months.
16. Subjects who have any implanted electronic devices (a pacemaker, for example), permanent or transient, that cannot be removed prior to the treatment.
17. Subjects who have received tibial or sacral nerve stimulation (SNS) anytime in the past or percutaneous tibial nerve (PTNS) in the last 3 months.
18. Previous urinary incontinence surgery or prolapse surgery or de novo urinary incontinence post-surgery within the last 12 months.
19. Any spinal surgery within the last 12 months.
20. Previous abdominoperineal resection of the rectum or previous radical hysterectomy.
21. Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines.
22. History of evidence of anatomic pelvic, urological or urogenital abnormality according to investigator’s discretion.
23. 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.
24. 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.
25. Subject with abnormal renal function defined by estimated glomerular filtration rate (eGFR) of 30 ml/min or less.
26. History of pelvic radiotherapy or chemotherapy for pelvic malignancies.
27. Diabetes with peripheral nerve neuropathy or severe uncontrolled diabetes (with HbA1C > 7.5%).
28. Uterine prolapse, cystocele, enterocele or rectocele past the hymen.
29. Deemed unsuitable for enrollment by the investigator based on history or physical examination.
30. Any psychiatric or personality disorder at the discretion of the study physician.
31. 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
32. Subject is breastfeeding.
33. Drug or alcohol abuse

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Safety: Incidence of drug and device related adverse events from treatment to 12-weeks post treatment.
2. Usability: Physician, Subject and Technician’s questionnaires.

Secondary endpoints 6

1. Mean change from baseline in the average number of daily Urgency Urinary Incontinence (UUI) Episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary.
2. Mean change from Baseline in the average number of daily voiding episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary.
3. Mean Change from baseline in Urinary grade 3 or 4 Urgency Episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary.
4. Mean change from baseline in Number of large leaks at 6 and 12- weeks post treatment based on a 3-day voiding diary.
5. Change from baseline in QAB-q total score at week 12.
6. Mean change from baseline in the average number of daily Nocturia episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vensica Medical Ltd.

Sponsor organisation

Vensica Medical Ltd.

Address

4, Ha-Gavish

City

Netanya

Postcode

4250704

Country

Israel

Scientific contact point

Organisation

Vensica Medical Ltd.

Contact name

Avner Geva

Public contact point

Organisation

Vensica Medical Ltd.

Contact name

Avner Geva

Third parties 1

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications