RELIEVE (RandomizEd triaL of Intravesical xEomin for incontinence via the VibE system) - a randomized, prospective, multicenter, double blind, placebo and sham controlled study to assess the safety and efficacy of NT 201 intravesical administration using Vibe System in the treatment of female participants suffering from idiopathic overactive bladder

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526512-36-00

Enrollment

225

Registered

2026-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Overactive Bladder (OAB)

Brief summary

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

Detailed description

Change from baseline in the mean daily number of urgency episodes (Patient Perception of Intensity of Urgency Scale (PPIUS) 3 and 4) at 12 weeks post-treatment, Change from baseline in the mean daily number of urgency urinary incontinence (UUI) episodes at 12 weeks post-treatment, Change from baseline in I-QOL total score at 12 weeks post-treatment, Change from baseline in the mean daily number of large leak episodes at 12 weeks post-treatment, based on the 3-day diary

Interventions

DRUGCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD)

DRUGFREE OF COMPLEXING PROTEINS

DRUGPlacebo to NT 201 appears identical to IMP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from baseline in the mean daily number of urgency episodes (Patient Perception of Intensity of Urgency Scale (PPIUS) 3 and 4) at 12 weeks post-treatment, Change from baseline in the mean daily number of urgency urinary incontinence (UUI) episodes at 12 weeks post-treatment, Change from baseline in I-QOL total score at 12 weeks post-treatment, Change from baseline in the mean daily number of large leak episodes at 12 weeks post-treatment, based on the 3-day diary	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 22, 2026