Effects of Lumbopelvic Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2026-02-28

Brief Summary

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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, 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 massage therapy and exercise training for the lumbopelvic area in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design.

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Detailed Description

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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 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. Estimating that a 30% difference between the two groups is clinically significant (80% improvement in the score in the research arm and 50% in the control arm), with 80% power and a margin of error of 0.05 in the one-way hypothesis design, the minimum number of samples that should be included in the study was determined for each A total of 62 volunteers were calculated for the group, 31 of which were volunteers. Anticipating a 10% loss rate in volunteers during the study period, the final sample size was calculated as 68 individuals in total, 34 individuals for each research arm. The study will include 68 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 lumbopelvic 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 and residual urine volume after voiding by pelvic ultrasound. SPSS program will be used for data analysis. 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%.

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumbopelvic Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy

Group 1 will receive lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy.

Group Type EXPERIMENTAL

Lumbopelvic Massage

Intervention Type OTHER

10 minutes abdominal massage and 10 minutes lower back massage will be applied in each session. It will take 20 minutes in total.

Exercise Training

Intervention Type OTHER

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.

Pelvic Floor Electromyography (EMG) Biofeedback Therapy

Intervention Type DEVICE

Biofeedback therapy will be applied for 20 minutes in each session. During the application, adhesive surface electrodes will be placed on the perineum at 4 o'clock and 8 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.

Standard Urotherapy

Intervention Type BEHAVIORAL

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.

Standard Urotherapy and Biofeedback Therapy

Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy.

Group Type ACTIVE_COMPARATOR

Pelvic Floor Electromyography (EMG) Biofeedback Therapy

Intervention Type DEVICE

Biofeedback therapy will be applied for 20 minutes in each session. During the application, adhesive surface electrodes will be placed on the perineum at 4 o'clock and 8 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.

Standard Urotherapy

Intervention Type BEHAVIORAL

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.

Interventions

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Lumbopelvic Massage

10 minutes abdominal massage and 10 minutes lower back massage will be applied in each session. It will take 20 minutes in total.

Intervention Type OTHER

Exercise 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.

Intervention Type OTHER

Pelvic 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 4 o'clock and 8 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.

Intervention Type DEVICE

Standard 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No