RELIEVE Study, NT 201, Overactive Bladder, Phase 2
ClinicalTrials.gov Studies
Summary
The RELIEVE Study (NCT07553065) is a Phase 2b prospective, multicenter, double-blind, randomized, placebo and sham controlled clinical trial evaluating NT 201 delivered via the Vibe System in participants with idiopathic overactive bladder. The trial tests two dose levels of NT 201 (200U and 300U) against placebo/sham across multiple study sites. Clinical trial registrations on ClinicalTrials.gov provide public visibility into ongoing research but do not themselves create compliance obligations for regulated entities.
“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)”
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What changed
This document is a clinical trial registration entry for the RELIEVE Study on ClinicalTrials.gov, listing a Phase 2b interventional trial testing NT 201 (botulinum toxin) delivered intravesically via the Vibe System for treatment of idiopathic overactive bladder. The trial is randomized, double-blind, placebo and sham-controlled, and will assess safety, efficacy, and dose response at two dose levels. No compliance obligations are created by this registration itself.
For pharmaceutical and medical device manufacturers, this trial represents ongoing development activity for a combination product. The presence of dose-response arms (200U vs 300U) indicates dose optimization is a primary study objective. Companies developing competing OAB treatments or combination drug-device products should monitor enrollment progress and preliminary efficacy signals from this trial.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
Phase 2 NCT07553065 Kind: PHASE2 Apr 27, 2026
Abstract
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: NT 201 200U and Vibe System, NT 201 300U and Vibe System, Placebo and sham
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