Overactive Bladder (OAB)
Conditions
Brief summary
This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB).
Interventions
COMBINATION_PRODUCTNT 201 200U and Vibe System
Combination of NT 201 200U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
COMBINATION_PRODUCTNT 201 300U and Vibe System
Combination of NT 201 300U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
COMBINATION_PRODUCTPlacebo and sham
Placebo identical in package and appearance to NT 201 together with all steps of Vibe System preparation and insertion to the bladder, but without the actual activation of the ultrasound energy
Sponsors
Vensica Therapeutics Ltd.
TFS Trial Form Support
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Signed written informed consent 2. Female aged 18-80 3. Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment 4. Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary 5. Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day 6. Participants on antimuscarinics and/or beta-3 adrenergic agonists drugs should be on a stable dose for at least 1 month prior to screening and agree to remain on stable medication consumption until the 12-week follow-up visit 7. Participants on tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) drugs should be on stable dose for at least 3 months prior to enrollment and agree to remain on stable medication consumption until the 12-week follow-up visit Key
Exclusion criteria
1. Participant with Body Mass Index \> 40 kg/m2 2. Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct 3. Participant with known or suspected overactive bladder caused by any neurological conditions (neuromuscular disorders such as Myasthenia Gravis, Amyotrophic Lateral Sclerosis (ALS), Eaton-Lambert Syndrome, Alzheimer's, Parkinson, Multiple Sclerosis (MS), stroke, etc.) 4. Participant with suspected retention or with Post Void Residue (PVR)\> 150 ml, as measured during screening. Post void residual may be repeated one week after first assessment if the original value is greater than 150 ml 5. Participant is pregnant or breastfeeding 6. Participant with current or known recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone 7. Participant who has received botulinum toxin injections for any condition within the past 9 months 8. Participant who has received neurostimulation for the treatment of Overactive Bladder in the last 6 months. 9. Participant on any active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the past 4 weeks (Self-performed Kegels exercises are allowed) 10. Participant with more than minimal level of suspected stress incontinence or mixed incontinence with stress component likely to confound study outcome, based on a 3-day voiding diary or medical history, or when stress incontinence score in the Medical, Epidemiologic, and Social Aspects (MESA) incontinence questionnaire is higher than the urgency incontinence score 11. Participant with current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines as well as tubocurarine-type muscle relaxants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily urinary incontinence | 12 weeks | Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary |
Countries
United States
Contacts
CONTACTTami Abudi
Outcome results
None listed