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

NCT07553065 | Not Yet Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: ViXe-CLP-003
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Mean daily urinary incontinence

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

  12 weeks

Study Arms (3)

Active arm: NT 201 200U and Vibe System

ACTIVE COMPARATOR

Combination Product: NT 201 200U and Vibe System

Active arm: NT 201 300U and Vibe System

ACTIVE COMPARATOR

Combination Product: NT 201 300U and Vibe System

Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act

PLACEBO COMPARATOR

Combination Product: Placebo and sham

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

Active arm: NT 201 200U and Vibe System

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

Active arm: NT 201 300U and Vibe System

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

Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Participant on any active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the past 4 weeks (Self-performed Kegels exercises are allowed)
• Participant with more than minimal level of suspected stress incontinence or mixed incontinence with stress component likely to confound study outcome, based on a 3-day voiding diary or medical history, or when stress incontinence score in the Medical, Epidemiologic, and Social Aspects (MESA) incontinence questionnaire is higher than the urgency incontinence score
• Participant with current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines as well as tubocurarine-type muscle relaxants)

Sponsors & Collaborators

• Vensica Therapeutics Ltd.: lead
• TFS Trial Form Support: collaborator

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

incobotulinumtoxinA; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tami Abudi

CONTACT

972525989833; tami@vensica.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04