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

NCT03874780 | Completed

• 1 other identifier: CL-100
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events Reporting

  Incidence of device related SAEs

  7 days

Secondary Outcomes (5)

• Serious Adverse Events Reporting

  12 weeks

• Incontinence

  12 weeks

• Micturition

  12 weeks

• Nocturia

  12 weeks

• Urgency

  12 weeks

Other Outcomes (2)

• Treatment Response

  12 weeks

• Change in Quality of Life Total Score

  12 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects treated with Botox (TM) with the Vibe investigational delivery system

Device: Vibe Delivery system

Interventions

Vibe Delivery system DEVICE

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

Treatment

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 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Vensica Therapeutics Ltd.: lead

Study Sites (2)

Jablonec Nad Nisou Medical Center

Jablonec nad Nisou, Czechia

Location

Braga Medical Center

Braga, Portugal

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

• ‪Maya Shick‬

  Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: January 29, 2019
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); PT (1)