NCT07553065招募中2 期
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
Vensica Therapeutics Ltd.1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2026年8月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Mean daily urinary incontinence
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Active arm: NT 201 200U and Vibe System
Active Comparator
干预措施: NT 201 200U and Vibe System (Combination Product)
Active arm: NT 201 300U and Vibe System
Active Comparator
干预措施: NT 201 300U and Vibe System (Combination Product)
Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act
Placebo Comparator
干预措施: Placebo and sham (Combination Product)
结局指标
主要结局
Mean daily urinary incontinence
时间窗: 12 weeks
Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary
次要结局
未报告次要终点
研究者
研究点 (1)
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