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Overactive BladderNCT03874780

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

A study testing Vibe Delivery system in people with Overactive Bladder, run by Vensica Therapeutics Ltd. at 2 sites in 2 countries.

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

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. 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?
Vibe Delivery system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesin 2 countries
Study dates
29 Jan 2019to 31 Mar 2019
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 subjects between the ages of 18 to 80 years old diagnosed with idiopathic OAB.
  • Subject has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.
  • Subjects with symptoms of incontinence associated with OAB for ≥ 3 months prior to screening.
  • Subjects who are non-responsive, non-compliant or intolerable to pharmacologic oral therapy (e.g., anticholinergic agents).
  • Subject is willing and able to initiate self-catheterization post-treatment, if required.
  • Subjects with PVR ≤200 ml.
  • Subjects who are mentally competent, with the ability to understand and comply with the requirements of the study.
  • 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.

Who cannot join

  • Subjects currently using Clean intermittent catheterization (CIC) or indwelling catheter to manage their urinary incontinence.
  • 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.
  • Subjects with clinically significant Bladder Outlet Obstruction (BOO) according to medical history.
  • Subjects with active urinary tract infection, as diagnosed on screening urinalysis.
  • Subjects with known polyuria or polydipsia.
  • Subjects with a known positive diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
Show all 23Show fewer
  • Subjects with OAB due to any known neurological reason.
  • 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.
  • Subject with a 24-hour total urine volume voided greater than 3,000 ml, as measured at screening visit.
  • Predominance of stress incontinence in the opinion of the investigator, determined by medical history.
  • Subjects with vesico-ureteral reflux, genitourinary fistulae.
  • 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).
  • Subjects with prior Botox™ therapy of any serotype within 12 weeks for any indication, including urologic condition.
  • Subjects with a history of pelvic radiation therapy.
  • Subject who is morbidly obese (BMI > 40 Kg/m2).
  • 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.
  • Subjects on immunomodulatory therapy (suppressive or stimulatory).
  • 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.
  • Subjects with operative sling erosion.
  • History of interstitial cystitis/painful bladder syndrome, in the opinion of the investigator.
  • 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).
  • Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
  • Any other condition or medical history, that to the discretion of the investigator and/or Sponsor, excludes the subject from participation in the study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Czechia1 site

  • Jablonec Nad Nisou Medical Center

    Jablonec nad Nisou

Other trials in Czechia

Portugal1 site

  • Braga Medical Center

    Braga

Other trials in Portugal

About this study

Official title: 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.

Being tested
Vibe Delivery system
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.

  • Vibe Delivery systemDevice

    delivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system

Study groups in NCT03874780
Study groupRoleWhat they receive
TreatmentExperimentalSubjects treated with Botox (TM) with the Vibe investigational delivery system
Receives: Device: Vibe Delivery system

What is being measured

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

  1. Serious Adverse Events Reporting

    Incidence of device related SAEs

    Measured: 7 days

Secondary outcomes (5)

  1. Serious Adverse Events Reporting

    Incidence of device related SAEs within

    Measured: 12 weeks

  2. Incontinence

    Change from Baseline in the mean number of Episodes of Urinary Incontinence/24h, as assessed by urinary diary

    Measured: 12 weeks

  3. Micturition

    Change from Baseline in frequency of Micturition Episodes/24h, as assessed by urinary diary

    Measured: 12 weeks

  4. Nocturia

    Change from Baseline in Daily Average Number of Nocturia Episodes, as assessed by urinary diary

    Measured: 12 weeks

  5. Urgency

    Change from baseline in Urinary urgency, as assessed by urinary 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 posted14 Mar 2019
  2. Study start29 Jan 2019
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03874780
Sponsor's protocol ID
CL-100
Status last verified
Mar 2019
First submitted
12 Mar 2019
Last updated
5 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vibe Delivery system in people with Overactive Bladder, run by Vensica Therapeutics Ltd. at 2 sites in 2 countries.

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 8 inclusion and 23 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, 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. 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?

Serious Adverse Events Reporting (time frame: 7 days). 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 NCT03874780.

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 5 Dec 2019.

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