Not Yet RecruitingPhase 2

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

210 participantsStarted 2026-07

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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Inclusion criteria

✓. 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
✓. Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day
✓. Participants on antimuscarinics and/or beta-3 adrenergic agonists drugs should be on a stable dose for at least 1 month prior to screening and agree to remain on stable medication consumption until the 12-week follow-up visit
✓. Participants on tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) drugs should be on stable dose for at least 3 months prior to enrollment and agree to remain on stable medication consumption until the 12-week follow-up visit

Exclusion criteria

✕. 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
✕. Participant is pregnant or breastfeeding
✕. Participant with current or known recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone
✕. Participant who has received botulinum toxin injections for any condition within the past 9 months
✕. Participant who has received neurostimulation for the treatment of Overactive Bladder in the last 6 months.

What they're measuring

Mean daily urinary incontinence

Timeframe: 12 weeks

Trial details

NCT IDNCT07553065

SponsorVensica Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Tami Abudi

972525989833 tami@vensica.com

View on ClinicalTrials.gov More Overactive Bladder (OAB) trials