RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder

ConditionOveractive Bladder (OAB)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-80

SponsorVensica Therapeutics Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent

Female aged 18-80

Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment

Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary

Disqualifiers

Participant with Body Mass Index > 40 kg/m2

Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct

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.)

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

Trial design

Design model

Parallel

Treatments tested in this trial

NT 201 200U and Vibe System
Combination product
Combination of NT 201 200U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
NT 201 300U and Vibe System
Combination product
Combination of NT 201 300U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
Placebo and sham
Combination product
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

Treatment groups

210 Participants

are divided into 3 treatment groups

Group A: Active arm: NT 201 200U and Vibe SystemActive comparator 1 intervention

Group B: Active arm: NT 201 300U and Vibe SystemActive comparator 1 intervention

Group C: Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no actPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Mean daily urinary incontinence

Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vensica Therapeutics Ltd.

Lead sponsor

TFS Trial Form Support

Collaborator

Source ClinicalTrials.gov

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