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

NCT07553065 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-08-21

No results posted yet for this study

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).

Conditions

  • Overactive Bladder (OAB)

Interventions

COMBINATION_PRODUCT

NT 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_PRODUCT

NT 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_PRODUCT

Placebo 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 & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Vensica Therapeutics Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553065 on ClinicalTrials.gov