Core Massage and Exercise in Pediatric LUTD

NCT06251557 | Completed

• 1 other identifier: KA-23059
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Children; Biofeedback therapy; Urotherapy; core-based exercise; massage

Outcome Measures

Primary Outcomes (1)

• Symptom score

  Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire will be used to evaluate the symptom score.

  Change in symptom score from baseline up to end of 6th week

Secondary Outcomes (8)

• Frequency of voiding and incontinence

  Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week

• Maximum and mean voided volumes

  Change in maximum and mean voided volumes (ml) from baseline up to end of 6th week

• Uroflowmeter parameters- Maximum Flow Rate

  Change in uroflowmeter parameters from baseline up to end of 6th week

• Uroflowmeter parameters- Curve Type

  Change in uroflowmeter curve type from baseline up to end of 6th week

• Residual urine volume after voiding

  Change in residual urine volume after voiding from baseline up to end of 6th week

Study Arms (2)

Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy

EXPERIMENTAL

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

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

Standard Urotherapy and Biofeedback Therapy

ACTIVE COMPARATOR

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

Device: Pelvic Floor Electromyography (EMG) Biofeedback Therapy; Behavioral: Standard Urotherapy

Interventions

Exercise Training 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.

Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy

Pelvic Floor Electromyography (EMG) Biofeedback Therapy 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 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.

Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy; Standard Urotherapy and Biofeedback Therapy

Standard Urotherapy 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.

Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy; Standard Urotherapy and Biofeedback Therapy

Massage Therapy OTHER

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

Core-Based Massage and Exercise Training in addition to Standard Urotherapy and Biofeedback Therapy

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Burcu Sert Gürsen

Ankara, 06820, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25772695 BACKGROUND

• 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.

  PMID: 15711352 BACKGROUND

• 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.

  PMID: 31366055 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Massage; Exercise; Electromyography; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Mind-Body Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 20, 2024
• Primary Completion: February 3, 2026
• Study Completion: March 16, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)