Clinical trial NCT03874780: Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Vensica Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serious Adverse Events Reporting
timeFrame: 7 days
Secondary outcomes:
measure: Serious Adverse Events Reporting
timeFrame: 12 weeks
measure: Incontinence
timeFrame: 12 weeks
measure: Micturition
timeFrame: 12 weeks
measure: Nocturia
timeFrame: 12 weeks
measure: Urgency
timeFrame: 12 weeks
Other outcomes:
measure: Treatment Response
timeFrame: 12 weeks
measure: Change in Quality of Life Total Score
timeFrame: 12 weeks
Locations:
city: Jablonec Nad Nisou
country: Czechia
facility: Jablonec Nad Nisou Medical Center
city: Braga
country: Portugal
facility: Braga Medical Center
Study officials:
affiliation: Consultant
name: ‪Maya Shick‬
role: STUDY_DIRECTOR
References: