Clinical trial NCT06251557: Effects of Lumbopelvic Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction
Official title: Additional Effects of Lumbopelvic Massage and Exercise Training to Standard Urotherapy and Biofeedback Therapy in Children With Lower Urinary Tract Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: Children
Lumbopelvic massage therapy
Lumbopelvic exercise
Biofeedback therapy
Urotherapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 68
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

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 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%.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom score
timeFrame: Change in symptom score from baseline up to end of 6th week
Secondary outcomes:
measure: Frequency of voiding, incontinence and defecation
timeFrame: Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week
measure: Uroflowmeter parameters
timeFrame: Change in uroflowmeter parameters from baseline up to end of 6th week
measure: Residual urine volume after voiding
timeFrame: Change in residual urine volume after voiding from baseline up to end of 6th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Burcu Sert
Study officials:
References:
citation: Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
citation: Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.
citation: Morgan KE, Leroy SV, Corbett ST, Shepard JA. Complementary and Integrative Management of Pediatric Lower Urinary Tract Dysfunction Implemented within an Interprofessional Clinic. Children (Basel). 2019 Jul 30;6(8):88. doi: 10.3390/children6080088.