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

Part of paid clinical trials in Reno, Nevada.

Sponsor
Vensica Therapeutics Ltd.
Study ID
NCT07553065
Phase
PHASE2
Status
Recruiting
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Conditions

  • Overactive Bladder (OAB)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

First listed
Apr 27, 2026
Start date
Aug 14, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active arm: NT 201 200U and Vibe System
  • Active Comparator: Active arm: NT 201 300U and Vibe System
  • Placebo Comparator: Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act

Primary Outcome Measure

Mean daily urinary incontinence [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Urology NevadaRenoNevada89511

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Urology Nevada· Reno, NV

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