Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-01
Brief Title:
Effects of Lumbopelvic Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Additional Effects of Lumbopelvic Massage and Exercise Training to Standard Urotherapy and Biofeedback Therapy in Children With Lower Urinary Tract Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3197 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 005 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 GroupTime 22 factors Type-1 error level for statistical significance will be based on 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None