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Overactive BladderXAVIERNCT06345677

Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects

A study testing ViXe Xombination in people with Overactive Bladder, run by Vensica Therapeutics Ltd. at 8 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Overactive Bladder
What is being tested?
ViXe Xombination
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
8 sitesPortugal
Study dates
9 Jun 2023to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.
  • 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) any time 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Portugal8 sites

  • CHUC

    Coimbra

  • HSOG

    Guimarães

  • CHLN

    Lisbon

  • CHUSJ

    Porto

  • Hospital Lusíadas

    Porto

  • Hospital Prelada

    Porto

  • Hospital Luz Setúbal

    Setúbal

  • CHVNG

    Vila Nova de Gaia

Other trials in Portugal

About this study

Official title: 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)

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.

Being tested
ViXe Xombination, Placebo + Sham
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ViXe XombinationCombination product

    Combination of Xeomin and the ultrasound based delivery system (Vibe) for intravesical administration of the drug in a minimally invasive procedure

  • Placebo + ShamCombination product

    Placebo identical in package and appearance to Xeomin together with all steps of Vibe device preparation and activation, but without the actual operation of the ultrasound energy

Study groups in NCT06345677
Study groupRoleWhat they receive
ViXe CombinationExperimentalThis arm includes a combination of the Xeomin medication, a generic of the Botulinium Toxin A drug that is not currently approved for this indication, and the Vibe medical device, an experimental device for the delivery of Botulinium Toxin to the bladder for overactive bladder
Receives: Combination Product: ViXe Xombination
Placebo + ShamPlacebo comparatorThe placebo that will be used in the study is identical in its physical properties to the investigational drug and will be used in the same manner as the active drug. Sham procedure will include all the steps for device preparation and activation, without the actual transmission of ultrasound eneregy to the participant.
Receives: Combination Product: Placebo + Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events Rate

    Incidence of drug and device related adverse events from treatment to 12-weeks post treatment

    Measured: 12 weeks

  2. Usability and ease-of-use perception by investigator, subject and technician

    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.

    Measured: Procedure

Secondary outcomes (6)

  1. Daily Urgency Urinary Incontinence

    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

    Measured: 12 weeks

  2. Total Daily Episodes

    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

    Measured: 12 weeks

  3. Urinary Urgency

    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

    Measured: 12 weeks

  4. Voiding Leaks

    Mean change from baseline in Number of large leaks at 6 and 12-weeks post treatment based on a 3-day voiding diary

    Measured: 12 weeks

  5. Quality of Life Queationnsaire

    Change from baseline in OAB-q (Overactive Bladder - quality) total score at week 12. OAB-q is a two-domain questionnaire (symptom bother and health related quality of life), each of which is a 100-point scale. Higher scores reflect higher quality of life.

    Measured: 12 weeks

  6. Nocturia

    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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start9 Jun 2023
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345677
Sponsor's protocol ID
ViXe-CLP-0002
Acronym
XAVIER
Status last verified
Mar 2024
First submitted
20 Feb 2024
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All subjects will be assigned a unique study code that will not enable anyone outside of the study team on site to identify them. No personal data will be colected during the study other than date of birth.

Questions about this trial

What is this clinical trial studying?

A study testing ViXe Xombination in people with Overactive Bladder, run by Vensica Therapeutics Ltd. at 8 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events Rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06345677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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