EUCTR2014-001068-36-GB进行中（未招募）1 期
Onabotulinum toxin-A versus extended release tolterodine in the management ofidiopathic overactive bladder in children: A pilot randomised controlled trial (OVERT) - Botulinum toxin-A versus tolterodine for idiopathic overactive bladder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Children of both sexes between the age of 7 and 16 years inclusive, with clinical symptoms of IOAB. IOAB clinical symptoms are urgency, wetting episodes, increased frequency of micturition.
- •2.Symptoms must include episodes of daytime urinary incontinence. Symptomatic patients are defined as those who have symptoms of overactive bladder with at least two episodes of daytime wetting per week despite medication.
- •3.Incomplete resolution of symptoms after bladder training and at least six months of anticholinergic therapy (or at least four months duration of therapy at study registration). Anticholinergic therapy may comprise of Oxybutynin, Solifenacin or Tolterodine. Incomplete resolution is defined as per ICCS definition as no and partial response (less than 50% and 50 - 90% improvement respectively).
- •4.Urodynamic studies demonstrating either detrusor over activity and/or reduced bladder compliance and/or reduced bladder capacity.
- •Reduced bladder capacity is defined as bladder capacity smaller than 70% of expected capacity.
- •Expected bladder capacity (mls) is calculated as: (age{in years} +1) X 30
- •Reduced bladder compliance is defined as <15mls / cm H2O
- •Bladder compliance is calculated by dividing the change in bladder volume (?V) by the change in detrusor pressure (?pdet) during that change in bladder volume: Compliance (ml/cm H20) = ?V/?pdet
- •Two standard points are taken for calculation of bladder compliance – first is detrusor pressure at start of bladder filling; second is detrusor pressure at cystometric capacity or immediately before the start of any detrusor contraction that causes significant leakage
- •Detrusor overactivity is defined as bladder activity involving a rise of detrusor pressure of greater than 5 cm H2O above baseline
- •5.Ultrasound of the renal tract showing no structural abnormality, which could account for the symptoms.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Recurrent urinary tract infection (UTI) (more than two documented episodes in the last three months) not controlled with antibiotic prophylaxis.
- •2.The presence of a neurological pathology, which could account for incontinence, on physical examination.
- •3.Evidence of significant dysfunctional voiding.
- •4.Post-void residuals greater than 20% of predicted bladder capacity.
- •5.Previous treatment with Botox®
- •6.Allergy to Botox® or Tolterodine
- •7.Positive pregnancy test in post menarchal girls
- •8.Myasthenia gravis
- •9.Kidney transplant
- •10.Abnormal liver function (liver function tests > 3 times upper limit of laboratory normal range)
- •11.Severe ulcerative colitis, toxic megacolon, gastro-intestinal obstruction or intestinal atony.
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