Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Variation of DVISS score between PTNS treatment group and oxybutynin group
研究概览
简要总结
The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment.
Before inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6 to 16 years
- •Showing signs of OAB (pollakiuria (> 8 micturitions/d and/or urgenturia(>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)
- •No treatment for more than 3 months
- •Urotherapy rules followed for at least 1 month
- •Beneficiary of a social security plan
- •Signature of consent by parents/legal guardian(s) and child's agreement
排除标准
- •Neurological cause of bladder dysfunction,
- •History of pelvic surgery,
- •Significant post-micturition residual (> 10% of micturition),
- •Recurrent urinary tract infections (> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.
- •Pregnant or breast-feeding adolescents
- •Severe constipation resistant to treatment (Rome IV),
- •Contraindication to oxybutynin
- •Contraindication to the use of TENS (Urostim)
研究组 & 干预措施
oxybutynin
干预措施: Oxybutynin (Other)
TENS
干预措施: medical device Urostim (Device)
结局指标
主要结局
Variation of DVISS score between PTNS treatment group and oxybutynin group
时间窗: at 3 months
DVISS score is : Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire. The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format. The DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD.
次要结局
- variation of treatment duration between both groups(at 6 months)
- variation of time to treatment efficacy between both groups(at 6 months)
- variation of tolerance between both groups(at 6 months)
- variation of compliance between both groups(at 6 months)
- variation of long-term efficacy between both groups(at 18 months)
- variation of long-term efficacy of AOB frequency between both groups(at 24 months)
- variation of tolerance between both groups(at 3 months)
- variation of compliance between both groups(at 3 months)
- variation of long-term efficacy between both groups(at 12 months)