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

NCT06345677 | Completed

• 1 other identifier: ViXe-CLP-0002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• Adverse Events Rate

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

  12 weeks

• 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.

  Procedure

Secondary Outcomes (6)

• Daily Urgency Urinary Incontinence

  12 weeks

• Total Daily Episodes

  12 weeks

• Urinary Urgency

  12 weeks

• Voiding Leaks

  12 weeks

• Quality of Life Queationnsaire

  12 weeks

Study Arms (2)

ViXe Combination

EXPERIMENTAL

This 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

Combination Product: ViXe Xombination

Placebo + Sham

PLACEBO COMPARATOR

The 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.

Combination Product: Placebo + Sham

Interventions

ViXe Xombination COMBINATION_PRODUCT

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

ViXe Combination

Placebo + Sham COMBINATION_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

Placebo + Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vensica Therapeutics Ltd.: lead
• Blueclinical, Ltd.: collaborator

Study Sites (8)

CHUC

Coimbra, Portugal

Location

HSOG

Guimarães, Portugal

Location

CHLN

Lisbon, Portugal

Location

CHUSJ

Porto, Portugal

Location

Hospital Lusíadas

Porto, Portugal

Location

Hospital Prelada

Porto, Portugal

Location

Hospital Luz Setúbal

Setúbal, Portugal

Location

CHVNG

Vila Nova de Gaia, Portugal

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Palma dos Reis, Dr

  Principal investigator at CHLN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: April 3, 2024
• Study Start: June 9, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (8)