Lower Urinary Tract Symptoms
Conditions
Keywords
Children, Biofeedback therapy, Urotherapy, core-based exercise, massage
Brief summary
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.
Detailed description
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%.
Interventions
OTHERMassage Therapy
10 minutes abdominal massage and 10 minutes lower back massage will be applied in each session. It will take 20 minutes in total.
OTHERExercise Training
Exercise training will last approximately 10 minutes in each session. In the exercise training, lumbopelvic stabilization exercises (bridge, cat-and-cow and squatting exercises) will be performed for 10 repetitions, lumbopelvic flexibility exercises (child position, happy baby position, adductor muscle stretching, psoas muscle stretching) will be performed for 20 seconds and 5 repetitions, and diaphragmatic breathing exercises will be performed for 5 repetitions in supine, side lying and sitting positions.
DEVICEPelvic Floor Electromyography (EMG) Biofeedback Therapy
Biofeedback therapy will be applied for 20 minutes in each session. During the application, adhesive surface electrodes will be placed on the perineum at 3 o'clock and 9 o'clock for each child. Through these electrodes, the activity signals of the muscles in that area will be recorded superficially. By monitoring the regional muscle activity, feedback is provided to increase and/or decrease the activity according to the activity pattern. As a result, pelvic floor biofeedback therapy will teach the child the correct use of the pelvic floor muscles. During the session, pelvic floor awareness and relaxation exercises specific to the child will be practiced with visual animations.
BEHAVIORALStandard Urotherapy
The anatomy of the urinary system and related structures, the causes of voiding dysfunction and symptoms will be explained to the family and the child with visuals. A written form including timed voiding during the day, appropriate fluid intake, correct toilet posture, adequate and balanced nutrition will be given.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of voiding and incontinence | Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week | 3-day voiding diary will be used to evaluate the frequency of voiding, incontinence and defecation. |
| Maximum and mean voided volumes | Change in maximum and mean voided volumes (ml) from baseline up to end of 6th week | 3-day voiding diary will be used to evaluate the maximum and mean voided volumes (ml) |
| Uroflowmeter parameters- Maximum Flow Rate | Change in uroflowmeter parameters from baseline up to end of 6th week | Uroflowmeter test report will be used to evaluate the maximum flow rate (ml/sn) |
| Uroflowmeter parameters- Curve Type | Change in uroflowmeter curve type from baseline up to end of 6th week | Uroflowmeter test report will be used to record flow curve type. |
| Residual urine volume after voiding | Change in residual urine volume after voiding from baseline up to end of 6th week | Pelvic ultrasound will be used to evaluate residual urine volume (ml) after voiding. |
| Physical Fitness Assessment-Thoracic Expansion Capacity | Change in parameters from baseline up to end of 6th week | Thoracic expansion capacity (cm) |
| Physical Fitness Assessment- Sit-Up test | Change in parameters from baseline up to end of 6th week | Sit-Up test (number of repetitions in 30 seconds) |
| Physical Fitness Assessment- Sit and Reach Test | Change in parameters from baseline up to end of 6th week | Sit and Reach Test (cm) |
Countries
Turkey (Türkiye)
Outcome results
None listed