Core-Based Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Symptom score
研究概览
简要总结
Lower urinary tract dysfunctions (LUTD) are common in the pediatric population and include symptoms related to functional disorders. LUTD limits children and their parents socially, physically, and financially; leads to secondary comorbidities in the long term and negatively affects quality of life. Therefore, effective treatment of LUTD is important. Treatment options in children with LUTD include standard urotherapy, physiotherapy and rehabilitation practices, pharmacologic approaches, and Botulinum toxin type A injections. Pharmacologic treatment and invasive approaches have high side effect rates and compliance problems; therefore, conservative treatment methods should be completed first. The literature focuses on standard urotherapy, pharmacologic approaches and biofeedback therapy. However, standard urotherapy and biofeedback are first-line treatments for pediatric LUTD, but their success rates are often limited. In addition, the pelvic floor contributes to abdomino-lumbopelvic stability and works in synergy with diaphragm, deep abdominal muscles and spinal segments. To the best of our knowledge, there is no study in this population that comprehensively addresses the anatomical structures closely related to the pelvic floor with a more holistic perspective beyond the standard patient education and pelvic floor. Therefore, The aim of our study is to demonstrate the additional effects of core-based massage and exercise training in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design.
详细描述
Pediatric lower urinary tract dysfunction (LUTD) is a common and multifactorial health problem. A holistic perspective is required in treatment. Therefore, the aim of our study is to demonstrate the additional effects of massage therapy and exercise training for the abdomino-lumbopelvic area in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design. At the beginning of our study, sample size was estimated using the G Power 3.1.9.7 program. To detect a clinically significant difference of 30% between the groups (80% improvement in the research arm and 50% in the control arm) with 80% power and an alpha level of 0.05 based on a one-sided hypothesis, the minimum sample size was determined to be 42 participants, with 21 allocated to each group. The study will include 42 volunteer children aged 7-15 years with symptoms associated with functional LUTD, accompanied by their parents. Children will be randomly assigned to 2 separate groups according to an online computer generated, gender stratified block randomization list. Group 1 will receive core-based massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy. Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy. The treatments will be applied 2 days a week for 6 weeks. Children will be evaluated at the beginning of the study and at the end of the treatment (6th week). The primary outcome measure is the "Dysfunctional Voiding and Incontinence Score". Secondary outcome measures are 3-day voiding and defecation diaries data, uroflowmetry parameters, residual urine volume after voiding by pelvic ultrasound and physical fitness parameters. SPSS program will be used for data analysis. In the comparison of numerical data between 2 independent groups, "Independent Groups T Test" will be used when parametric assumptions are met and "Mann-Whitney U test" will be used when parametric assumptions are not met. In the analysis of change within the dependent group, "Significance Test of the Difference Between Two Pairs" will be used when parametric assumptions are met and "Wilcoxon Test" will be used when parametric assumptions are not met. In the examination of the change in outcome measurements over time, the effect of the treatments in both groups on the dependent variables in all evaluations (In-group factor, Time; pre-treatment and post-treatment) will be tested with "Repeated Measures of Anova" using Treatment Group*Time (2*2) factors. Type-1 error level for statistical significance will be based on 5%.
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
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 7 and 15
- •Presence of symptoms of functional lower urinary tract dysfunction
- •Do not have a condition (such as autism, ADHD-Attention Deficit and Hyperactivity Disorder) that would prevent cooperation with the assessments and interventions in the study
- •Consented to participate in the study by their parents
排除标准
- •Symptomatic urinary tract infection,
- •A neurological disease,
- •Neurogenic bladder/bowel diagnosis,
- •Monosymptomatic enuresis,
- •Anatomical anomaly that may affect bladder/bowel function,
- •Fecal incontinence,
- •Disruption of skin integrity or open wound at the massage site and
- •An orthopedic problem that would prevent them from performing the exercises in the study
研究组 & 干预措施
Standard Urotherapy and Biofeedback Therapy
Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy.
干预措施: Pelvic Floor Electromyography (EMG) Biofeedback Therapy (Device)
Standard Urotherapy and Biofeedback Therapy
Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy.
干预措施: Standard Urotherapy (Behavioral)
Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy
Group 1 will receive abdomino-lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy.
干预措施: Massage Therapy (Other)
Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy
Group 1 will receive abdomino-lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy.
干预措施: Exercise Training (Other)
Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy
Group 1 will receive abdomino-lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy.
干预措施: Pelvic Floor Electromyography (EMG) Biofeedback Therapy (Device)
Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy
Group 1 will receive abdomino-lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy.
干预措施: Standard Urotherapy (Behavioral)
结局指标
主要结局
Symptom score
时间窗: Change in symptom score from baseline up to end of 6th week
Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire will be used to evaluate the symptom score.
次要结局
- Residual urine volume after voiding(Change in residual urine volume after voiding from baseline up to end of 6th week)
- Frequency of voiding and incontinence(Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week)
- Maximum and mean voided volumes(Change in maximum and mean voided volumes (ml) from baseline up to end of 6th week)
- Uroflowmeter parameters- Maximum Flow Rate(Change in uroflowmeter parameters from baseline up to end of 6th week)
- Uroflowmeter parameters- Curve Type(Change in uroflowmeter curve type from baseline up to end of 6th week)
- Physical Fitness Assessment-Thoracic Expansion Capacity(Change in parameters from baseline up to end of 6th week)
- Physical Fitness Assessment- Sit-Up test(Change in parameters from baseline up to end of 6th week)
- Physical Fitness Assessment- Sit and Reach Test(Change in parameters from baseline up to end of 6th week)
研究者
SERAP ÖZGÜL
Prof. Dr.
Hacettepe University