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

University of Zurich (UZH)

Status: Completed

Conditions: Incontinence, Urinary

Treatments: Device: Whole Body Vibration Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04737447

10642

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A (Control Group)

Active Comparator group

Description:

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.

Treatment:

Device: Whole Body Vibration Training

Group B (Study Group)

Active Comparator group

Description:

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.

Treatment:

Device: Whole Body Vibration Training