Marschall-Kehrel Daniela, Feustel Cornelia, Persson de Geeter Charlotta, Stehr Maximilian, Radmayr Christian, Sillén Ulla, Strugala Gerhard
Eur Urol. 2009 Mar;55(3):729-36. doi: 10.1016/j.eururo.2008.04.062. Epub 2008 May 7.
Until now no confirmatory clinical trial in children suffering from nonneurogenic overactive bladder (OAB) and urinary incontinence could demonstrate superiority for antimuscarinics over placebo.
The following study was conducted to prove efficacy and tolerability of propiverine compared to placebo.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled phase 3 trial with parallel-group design in children aged 5-10 yr was performed. Prior to the 8-wk medical therapy urologic baseline diagnostics, a 3-wk lifestyle advice (urotherapy) was established.
After re-evaluation of in- and exclusion criteria and uroflowmetry, only children fulfilling the requested criteria were allocated to a body-weight-adjusted therapy (10 or 15 mg propiverine twice daily or corresponding placebo).
Efficacy parameters derived from bladder diary and a micturition volume protocol. Decrease in voiding frequency per day was chosen as primary efficacy parameter; secondary endpoints included voided volume and incontinence episodes. A safety assessment was conducted.
Of 171 randomized children, 87 were treated with propiverine and 84 with placebo. The primary efficacy parameter showed a decrease in voiding frequency (-2.0 episodes for propiverine versus -1.2 for placebo; p=0.0007). Superiority could also be demonstrated for voided volume (31.4 vs. 5.1 ml; p<0.0001) and incontinence episodes (-0.5 vs. -0.2 episodes per d; p=0.0005). The trial design did not allow for separate evaluation of the effect of urotherapy prior to medical treatment. Propiverine was well-tolerated in children. Altogether 23% of side-effects were reported for propiverine and 20% for placebo.
This clinical trial showed superior efficacy of propiverine over placebo and good tolerability for the treatment of children suffering from OAB and urinary incontinence. An important additional factor for the success of the trial was a modified trial design with previous urotherapy.
ClinicalTrials.gov Identifier: NCT00603343.
迄今为止，尚无针对非神经源性膀胱过度活动症（OAB）和尿失禁患儿的验证性临床试验能够证明抗毒蕈碱药物比安慰剂更具优势。
进行以下研究以证明丙哌维林与安慰剂相比的疗效和耐受性。
设计、地点和参与者：对5至10岁儿童进行了一项随机、双盲、安慰剂对照的3期平行组试验。在为期8周的药物治疗前进行了泌尿外科基线诊断，并提供了为期3周的生活方式建议（尿流改道治疗）。
在重新评估纳入和排除标准以及尿流率后，仅将符合要求标准的儿童分配至根据体重调整的治疗组（每日两次服用10或15毫克丙哌维林或相应的安慰剂）。
从膀胱日记和排尿量记录中得出疗效参数。选择每日排尿频率的降低作为主要疗效参数；次要终点包括排尿量和尿失禁发作次数。进行了安全性评估。
171名随机分组的儿童中，87名接受丙哌维林治疗，84名接受安慰剂治疗。主要疗效参数显示排尿频率降低（丙哌维林组降低2.0次，安慰剂组降低1.2次；p = 0.0007）。在排尿量（31.4对5.1毫升；p < 0.0001）和尿失禁发作次数（每日-0.5对-0.2次；p = 0.0005）方面也显示出优势。试验设计不允许在药物治疗前单独评估尿流改道治疗的效果。丙哌维林在儿童中耐受性良好。丙哌维林组共报告了23%的副作用，安慰剂组为20%。
这项临床试验表明，丙哌维林治疗OAB和尿失禁患儿的疗效优于安慰剂，且耐受性良好。该试验成功的一个重要额外因素是采用了先前进行尿流改道治疗的改良试验设计。
ClinicalTrials.gov标识符：NCT00603343。
