Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial

NCT04737447 | Completed

• 1 other identifier: 10642
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The determined study category is a prospective clinical randomized controlled study to evaluate the effect of WBVT in combination with urophysiotherapy to playfully expand the therapeutic options for children and adolescents with incontinence. This will be the first time use of WBVT for treating incontinence in children.

Conditions

Incontinence, Urinary

Keywords

Whole Body Vibration Training (WBVT); Incontinence in children

Outcome Measures

Primary Outcomes (2)

• Change of Dysfunctional Voiding and Incontinence Score (DVISS)

  Incontinence score for children.This statistically validated functional voiding problems symptom score may provide accurate, objective and scientific bases to grade the symptoms in comparative research, diagnosis, treatment and followup of patients with wetting and functional voiding disorders. It contains 13 questions. The following applies: A child is continent when score is \< 9 points and therefore responding to the therapy. Score decrease more than 30% means partial responding. Score decrease less than 30% means the failure of therapy.

  Change of DVISS between Baseline and Post-interventional at 12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention

• Change of Revised Urinary Incontinence Scale (RUIS)

  Incontinence Score for adults.The RUIS is a short, reliable and valid five item scale that can be used to assess urinary incontinence and to monitor patient outcomes following treatment. The following applies: Incontinence is mild if scoring is less than 4, incontinence is moderate if scoring is between 4 and 8 and severe if it is more than 13.

  Change of RUIS between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)

Secondary Outcomes (2)

• Change of Urinary flow measurements (UF)

  Change of UF between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)

• Change of Postvoid residual urine (PVR)

  Change of PVR between Baseline and post-interventional (12 weeks after Beginning of Intervention, 2 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)

Study Arms (2)

Group A (Control Group)

ACTIVE COMPARATOR

20 participants treated with standardized urophysiotherapy twice a week, once for 45 Minutes and then for 15 Minutes. Urophysiotherapy is a well manifested and standardized therapy in the treatment für children's incontinence after the age of five years.

Device: Whole Body Vibration Training

Group B (Study Group)

ACTIVE COMPARATOR

20 participants treated with standardized urophysiotherapy and Whole Body Vibration training (WBVT). These patients are treated with the standardized urophysiotherapy once a week and furthermore they train with WBVT twice a week for each time 15 minutes. Criteria for modifying the device utilization are based on participant's age and therapy progress. The utilized frequency of the device is individually adapted to the participant. Older patients (\> ten years old) are allowed to higher frequency standards than younger participants (\< 10 years old). The amplitude (0.5 mm - 2 mm) is alternated to the participant's age and height. If side effects occur (e.g. dizziness), frequency can be alternated. The intended frequency level is between 10 an 20 Hz.

Device: Whole Body Vibration Training

Interventions

Whole Body Vibration Training DEVICE

Galileo® Trainer is a vibration board. The movement alternating to different sides during walking correlates with the movement on the board due to variable amplitudes and frequencies. Movements of the vibration board are quickly changing and thus simulating the tilting movements of the pelvic during walking but with higher frequency. Muscles of legs and core are activated reflexively. In our study there are performed static practices and pelvic activating practices. Each physiotherapist is experienced in the technical and practical handling of the device.

Also known as: Galileo Training

Group A (Control Group); Group B (Study Group)

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and Female participants 7-16 years of age
• Daytime incontinence (\> 6 months)
• Written informed consent by the participant after information about the research project

You may not qualify if:

• Neurogenic bladder dysfunction
• Congenital anomalies of the urinary tract
• Patients who already take part in another study concerning treating incontinence 30 days before and after participation in this study
• Patients with incontinence, who already underwent urophysiotherapy
• Medication for treating incontinence
• Contraindications for the use of Galileo®: epilepsy, acute fractures, urolithiasis, cholecystolithaisis, after recent surgery, acute hernia, arthritis, thrombosis, rheumatic diseases, acute discopathy, patients with implants diabetes or pregnancy.
• Patients and parents without any motivation for urophysiotherapy
• Patients who neither

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hoelscher

  Consultant in Pediatric Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible because of active patient's participation in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Alice Catherine Hoelscher

Model Details: In this randomized controlled trial children with incontinence will be randomly assigned in two groups: an "urophysiotherapy plus WBVT" group and a control group receiving urophysiotherapy only. Statistical analysis will be randomised-controlled and prospective. Two groups will be compared: Group A = 20 participants treated with standardized urophysiotherapy. Group B = 20 participants treated with standardized urophysiotherapy and WBVT. According to this parameters and statistical tests will be used. Primary and secondary outcomes will be statistically described by the average (mean, median), standard deviation, frequency and percentage. The analysis will be univariant. For continuant outcomes the Student's t-Test will be used. Chi-Square Test or Fisher's Exact Test will analyze small numbers in binary or categorical outcomes. The level of significance (alpha) is 0.05

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: February 3, 2021
• Study Start: January 15, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CH (1)