A Randomized-controlled Trial Comparing Transcutaneous Tibial Nerve Stimulation (TTNS) Versus Sham Therapy on Short Term Continence Outcomes in Children With the Idiopathic Overactive Bladder Syndrome: the TaPaS Trial Part I
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mean voided volume per void
研究概览
简要总结
Part I of the TaPaS trial forms part of a twofold clinical RCT:
Part 1) A prospective RCT comparing the efficacy of transcutaneous tibial nerve stimulation (TTNS) with TTNS sham therapy for children with idiopathic overactive bladder on clinical and patient reported outcomes (PROMS).
Part 2) A prospective RCT comparing TTNS versus Percutaneous tibial nerve stimulation (PTNS) on clinical outcomes and PROMS.
详细描述
Non invasive neuromodulation therapy for children with the overactive bladder syndrome is a highly under investigated topic in medical literature.
Only 2 studies ( Patidar et al. and Boudaouid et al.) investigated the use of tibial nerve stimulation with adhesive electrodes.
- In the first trial the superiority of TTNS vs.Sham therapy for the therapeutic management of children with OAB naive to any pharmacological treatment will be examined.
Clinical outcomes will be assessed by the use of daytime and nighttime bladder diaries.
Assessment of outcomes at baseline, after 6 weeks and 12 weeks of treatment, and investigation of mean time to partial or complete relapse following 6 weeks observation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded for the given treatment ( Active TTNS vs. Sham TTNS) by the care provider ( Physiotherapist).
The outcomes assessor (the pediatric urologist) isn't aware of the treatment neither.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 5 and 12 years old, clinically diagnosed with the idiopathic overactive bladder syndrome with urinary incontinence (daytime and/or nighttime)
- •Untreated, except from urotherapy.
排除标准
- •Enuresis nocturna due to nocturnal polyuria
- •Dysfunctional voiding
- •Neurogenic bladder
- •Psychiatric disorders, behavioural disturbances or mental disabilities
- •Treated before with pharmacotherapy or invasive therapies for OAB
- •Children with parents unable to record reliably micturition diaries.
研究组 & 干预措施
Active TTNS
Children treated by transcutaneous tibial nerve stimulation. TENS device connected to adhesive electrodes. Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
干预措施: TTNS (Device)
TTNS sham intervention
Children treated by TTNS with same positioning as the active TTNS treatment. Stimulation settings: 200 µS, 20 Hz, 0-1 V. Patients and parents will be told that electric currence is given, but that no sensation will be feld.
Home therapy: Daily stimulation during 60 minutes.
干预措施: TTNS Sham (Device)
结局指标
主要结局
Mean voided volume per void
时间窗: 12 weeks
Difference in mean voided volume per void in percentage
次要结局
- Maximum voided volume (ml)(12 weeks)
- Number of urgency incontinence episodes / 24 h.(12 weeks)
- Daytime voiding frequency(12 weeks)
- Satisfaction on urinary symptoms reported by parents(12 weeks)
- Time to recurrence(At 12 weeks of treatment + at 6 weeks of observational period without treatment.)