NCT07594353尚未招募不适用
Maintenance Parasacral Electrical Nerve Stimulation Versus Observation After Initial Response in Children With Primary Nocturnal Enuresis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
Paracascral transcutaneous electrical nerve stimulation (PTENS) is a credible therapeutic option for nocturnal enuresis. The investigators shall investigate whether maintenance PTENS after initial response improves durability of remission compared with observation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary monosymptomatic nocturnal enuresis (PMNE) based on International Children's Continence Society (ICCS) criteria.
- •Persistent symptoms after at least 8 weeks of standardized urotherapy, including counseling on timed voiding, evening fluid management, and bowel optimization.
- •Baseline severity of ≥3 wet nights per week on a 14-night diary.
- •Ability of the child and caregiver to complete diaries and comply with home treatment and follow-up.
排除标准
- •Non-monosymptomatic enuresis, daytime urgency, daytime incontinence, dysfunctional voiding, or significant post-void residual.
- •Neurogenic bladder, spinal dysraphism, cerebral palsy, epilepsy uncontrolled on treatment, or other neurologic diseases affecting lower urinary tract function.
- •Congenital or acquired urinary tract abnormalities.
- •Active urinary tract infection.
- •Untreated or refractory constipation at enrollment.
- •Implanted electrical devices, significant dermatologic lesions at electrode sites, or other contraindications to electrical stimulation.
- •Cognitive, behavioral, or social circumstances preventing adherence.
研究者
Abdelrhman Alshawadfy
professor
Suez Canal University
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