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

Incontinence, Urinary Clinical Trial

— WBVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737447
• Other study ID #: 10642
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: University Children's Hospital, Zurich
• Contact: Hoelscher
• Phone: +41044 266 7392
• Email: alice.hoelscher[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Approximately up to 20% of children suffer from urinary incontinence. These children and frequently their families are emotionally and behaviourally affected which in turn leads to psychological distress. Urophysiotherapy became one of the first line treatments for children with urinary incontinence. Urophysiotherapy includes pelvic floor muscles training (PFMT), a treatment method not easily applicable in children. We therefore supplement the standard training with WBVT which is already evaluated in the adult population to improve the strength of the muscles of the pelvic floor. With the medical device of Galileo® children are able to train the pelvic muscles automatically and playfully.The primary objective is to investigate the effect of WBVT on children's incontinence measured by validated incontinence scores (DVISS, RUIS). The secondary objective is to evaluate the effect on the bladder function (uroflowmetry, residual urine).The primary outcome is to significantly improve incontinence symptoms by using WBVT in combination with urophysiotherapy for 9 weeks measured by incontinence scores.I nclusion criteria

• 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 Exclusion criteria

• 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 mentally nor physically are able to pursue urophysiotherapy

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. The children will be treated in both groups according to a standardized protocol for 9 weeks. In addition to clinical investigations and urodynamic studies two different incontinence scores (DVISS and RUIS) will be used to determine the severity of incontinence at the time of diagnosis, at the end of the therapy (12 weeks after assessment), 24 and at 48 weeks after assessment. To determine the effect of WBVT the results will be compared using the Student's t-test and the Mann-Whitney U test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Urinary Incontinence

Intervention

Device:
• Whole Body Vibration Training
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.

Locations

Country	Name	City	State
Switzerland	University Children's Hospital	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change of Urinary flow measurements (UF)	Urinary flow rate assessment is a basic noninvasive urodynamic test that is widely used to distinguish micturition problems. Key parameters are maximal flow rate (Qmax), voided volume, and flow pattern. Uroflowmetry parameters should ideally be evaluated when the voided volume is > 150 mL. The diagnostic accuracy of uroflowmetry for detecting bladder outlet obstruction varies considerably and is substantially influenced by diagnostic threshold values. Low Qmax can arise as a consequence of bladder outlet obstruction, detrusor underactivity, or an underfilled bladder.	Change of UF between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)
Secondary	Change of Postvoid residual urine (PVR)	Postvoid residual urine (PVR) is the amount of urine retained in the bladder after a voluntary void and functions as a diagnostic tool. In our study, it is measured by bladder scan after urinary flow measurement to detect how much urine is left in the bladder.	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)