Clinical trial NCT04737447: Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial
Official title: Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urinary
Keywords: Whole Body Vibration Training (WBVT)
Incontinence in children
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Dysfunctional Voiding and Incontinence Score (DVISS)
timeFrame: Change of DVISS between Baseline and Post-interventional at 12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention
measure: Change of Revised Urinary Incontinence Scale (RUIS)
timeFrame: Change of RUIS between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)
Secondary outcomes:
measure: Change of Urinary flow measurements (UF)
timeFrame: Change of UF between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)
measure: Change of Postvoid residual urine (PVR)
timeFrame: 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)
Other outcomes:
Locations:
city: Zuerich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: Consultant in Pediatric Urology
name: Hoelscher
role: PRINCIPAL_INVESTIGATOR
References: