Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder

December 3, 2019 updated by: Vensica Therapeutics Ltd.

First in Human (FIH) Study for the Evaluation of the Safety and Early Performance of the Vibe Delivery System for the Delivery of Botox™ in Subjects With Idiopathic Overactive Bladder (OAB)

This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Jablonec Nad Nisou, Czechia
        • Jablonec Nad Nisou Medical Center
  • Portugal
      • Braga, Portugal
        • Braga Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female subjects between the ages of 18 to 80 years old diagnosed with idiopathic OAB.
  2. Subject has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.
  3. Subjects with symptoms of incontinence associated with OAB for ≥ 3 months prior to screening.
  4. Subjects who are non-responsive, non-compliant or intolerable to pharmacologic oral therapy (e.g., anticholinergic agents).
  5. Subject is willing and able to initiate self-catheterization post-treatment, if required.
  6. Subjects with PVR ≤200 ml.
  7. Subjects who are mentally competent, with the ability to understand and comply with the requirements of the study.
  8. A negative urine pregnancy test during screening in women with childbearing potential. A female subject will also agree to use an adequate birth control method for the duration of her participation in the study and for a period of 6 months after participation completion.

Exclusion Criteria:

  1. Subjects currently using Clean intermittent catheterization (CIC) or indwelling catheter to manage their urinary incontinence.
  2. Pregnant or breastfeeding women, or women of childbearing potential who are planning to become pregnant during the study period or not practicing reliable contraception methods.
  3. Subjects with clinically significant Bladder Outlet Obstruction (BOO) according to medical history.
  4. Subjects with active urinary tract infection, as diagnosed on screening urinalysis.
  5. Subjects with known polyuria or polydipsia.
  6. Subjects with a known positive diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
  7. Subjects with OAB due to any known neurological reason.
  8. Subjects currently undergoing biofeedback, pelvic muscle rehabilitation, pelvic floor physical therapy, or electrical-stimulation who are unwilling to discontinue such treatments for the duration of study participation.
  9. Subject with a 24-hour total urine volume voided greater than 3,000 ml, as measured at screening visit.
  10. Predominance of stress incontinence in the opinion of the investigator, determined by medical history.
  11. Subjects with vesico-ureteral reflux, genitourinary fistulae.
  12. Subjects with pelvic organ prolapse stage III or IV, (i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen at straining).
  13. Subjects with prior Botox™ therapy of any serotype within 12 weeks for any indication, including urologic condition.
  14. Subjects with a history of pelvic radiation therapy.
  15. Subject who is morbidly obese (BMI > 40 Kg/m2).
  16. Subjects with a history of treatment for two or more UTIs within 6 months prior to screening or use of prophylactic antibiotics to prevent chronic UTIs.
  17. Subjects on immunomodulatory therapy (suppressive or stimulatory).
  18. History or evidence of any pelvic or lower tract genitourinary abnormalities, malignancy, bladder surgery (excluding stress incontinence or pelvic organ prolapse surgeries), or disease, other than OAB.
  19. Subjects with operative sling erosion.
  20. History of interstitial cystitis/painful bladder syndrome, in the opinion of the investigator.
  21. Subjects with current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
  22. Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
  23. Any other condition or medical history, that to the discretion of the investigator and/or Sponsor, excludes the subject from participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Subjects treated with Botox (TM) with the Vibe investigational delivery system
Device: Vibe Delivery system
delivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events Reporting
Time Frame: 7 days
Incidence of device related SAEs
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events Reporting
Time Frame: 12 weeks
Incidence of device related SAEs within
12 weeks
Incontinence
Time Frame: 12 weeks
Change from Baseline in the mean number of Episodes of Urinary Incontinence/24h, as assessed by urinary diary
12 weeks
Micturition
Time Frame: 12 weeks
Change from Baseline in frequency of Micturition Episodes/24h, as assessed by urinary diary
12 weeks
Nocturia
Time Frame: 12 weeks
Change from Baseline in Daily Average Number of Nocturia Episodes, as assessed by urinary diary
12 weeks
Urgency
Time Frame: 12 weeks
Change from baseline in Urinary urgency, as assessed by urinary diary
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Response
Time Frame: 12 weeks
Percentage of subjects who have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
12 weeks
Change in Quality of Life Total Score
Time Frame: 12 weeks

Change from baseline in Overactive Bladder Quality of life (OAB-q) total score. The OAB-q questionnaire is a validated, multi-sectional questionnaire that assesses the patient's coping with overactive bladder symptoms. The questionnaire is commonly used in clinical research and clinical setting for this indication, and consists of the following 6 scores:

  • Symptoms severity score
  • Coping score
  • Concern/worry score
  • Social score
  • Sleep score
  • Quality of life score These scores are further analyzed to obtain two domains: Quality of Life total score (improvement is demonstrated in higher scores), and Symptoms Bother Score (improvement is demonstrated in lower scores).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vensica Therapeutics Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ‪Maya Shick‬, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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