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

Hacettepe University

Status: Not yet enrolling

Conditions: Lower Urinary Tract Symptoms

Treatments: Other: Exercise Training; Other: Lumbopelvic Massage; Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy; Behavioral: Standard Urotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06251557

KA-23059

Details and patient eligibility

About

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.

Full 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 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%.

Enrollment: 68 estimated patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: Standard Urotherapy

Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy

Other: Lumbopelvic Massage

Other: Exercise Training

Standard Urotherapy and Biofeedback Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Urotherapy

Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy