Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of Dysfunctional Voiding and Incontinence Score (DVISS)
研究概览
简要总结
The determined study category is a prospective clinical randomized controlled study to evaluate the effect of WBVT in combination with urophysiotherapy to playfully expand the therapeutic options for children and adolescents with incontinence. This will be the first time use of WBVT for treating incontinence in children.
详细描述
Approximately up to 20% of children suffer from urinary incontinence. These children and frequently their families are emotionally and behaviourally affected which in turn leads to psychological distress. Urophysiotherapy became one of the first line treatments for children with urinary incontinence. Urophysiotherapy includes pelvic floor muscles training (PFMT), a treatment method not easily applicable in children. We therefore supplement the standard training with WBVT which is already evaluated in the adult population to improve the strength of the muscles of the pelvic floor. With the medical device of Galileo® children are able to train the pelvic muscles automatically and playfully.The primary objective is to investigate the effect of WBVT on children's incontinence measured by validated incontinence scores (DVISS, RUIS). The secondary objective is to evaluate the effect on the bladder function (uroflowmetry, residual urine).The primary outcome is to significantly improve incontinence symptoms by using WBVT in combination with urophysiotherapy for 9 weeks measured by incontinence scores.I nclusion criteria
- Male and Female participants 7-16 years of age
- Daytime incontinence (> 6 months)
- Written informed consent by the participant after information about the research project Exclusion criteria
- Neurogenic bladder dysfunction
- Congenital anomalies of the urinary tract
- Patients who already take part in another study concerning treating incontinence 30 days before and after participation in this study
- Patients with incontinence, who already underwent urophysiotherapy
- Medication for treating incontinence
• Contraindications for the use of Galileo®: epilepsy, acute fractures, urolithiasis, cholecystolithaisis, after recent surgery, acute hernia, arthritis, thrombosis, rheumatic diseases, acute discopathy, patients with implants diabetes or pregnancy.
- Patients and parents without any motivation for urophysiotherapy
- Patients who neither mentally nor physically are able to pursue urophysiotherapy
In this randomized controlled trial children with incontinence will be randomly assigned in two groups: an "urophysiotherapy plus WBVT" group and a control group receiving urophysiotherapy only. The children will be treated in both groups according to a standardized protocol for 9 weeks. In addition to clinical investigations and urodynamic studies two different incontinence scores (DVISS and RUIS) will be used to determine the severity of incontinence at the time of diagnosis, at the end of the therapy (12 weeks after assessment), 24 and at 48 weeks after assessment. To determine the effect of WBVT the results will be compared using the Student's t-test and the Mann-Whitney U test.
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
- None
盲法说明
Masking is not possible because of active patient's participation in the study.
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female participants 7-16 years of age
- •Daytime incontinence (> 6 months)
- •Written informed consent by the participant after information about the research project
排除标准
- •Neurogenic bladder dysfunction
- •Congenital anomalies of the urinary tract
- •Patients who already take part in another study concerning treating incontinence 30 days before and after participation in this study
- •Patients with incontinence, who already underwent urophysiotherapy
- •Medication for treating incontinence
- •Contraindications for the use of Galileo®: epilepsy, acute fractures, urolithiasis, cholecystolithaisis, after recent surgery, acute hernia, arthritis, thrombosis, rheumatic diseases, acute discopathy, patients with implants diabetes or pregnancy.
- •Patients and parents without any motivation for urophysiotherapy
- •Patients who neither
结局指标
主要结局
Change of Dysfunctional Voiding and Incontinence Score (DVISS)
时间窗: Change of DVISS between Baseline and Post-interventional at 12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention
Incontinence score for children.This statistically validated functional voiding problems symptom score may provide accurate, objective and scientific bases to grade the symptoms in comparative research, diagnosis, treatment and followup of patients with wetting and functional voiding disorders. It contains 13 questions. The following applies: A child is continent when score is \< 9 points and therefore responding to the therapy. Score decrease more than 30% means partial responding. Score decrease less than 30% means the failure of therapy.
Change of Revised Urinary Incontinence Scale (RUIS)
时间窗: Change of RUIS between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)
Incontinence Score for adults.The RUIS is a short, reliable and valid five item scale that can be used to assess urinary incontinence and to monitor patient outcomes following treatment. The following applies: Incontinence is mild if scoring is less than 4, incontinence is moderate if scoring is between 4 and 8 and severe if it is more than 13.
次要结局
- Change of Postvoid residual urine (PVR)(Change of PVR between Baseline and post-interventional (12 weeks after Beginning of Intervention, 2 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention))
- Change of Urinary flow measurements (UF)(Change of UF between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention))
研究者
Alice Hoelscher
Dr. med. Alice Catherine Hoelscher
University Children's Hospital, Zurich