Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for O… (NCT06345677) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects
Portugal48 participantsStarted 2023-06-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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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), 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
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.…
What they're measuring
1
Adverse Events Rate
Timeframe: 12 weeks
2
Usability and ease-of-use perception by investigator, subject and technician