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

Официальное название

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

Обзор

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).

Вмешательства

• Комбинированный продукт 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
• Комбинированный продукт 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
• Комбинированный продукт 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

Первичные конечные точки

• Mean daily urinary incontinence [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07553065 · ViXe-CLP-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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