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

Incontinence, Urinary Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Urinary Incontinence

• NCT number: NCT04737447
• Study type: Interventional
• Source: University Children's Hospital, Zurich
• Contact: Hoelscher
• Phone: +41044 266 7392
• Email: alice.hoelscher@kispi.uzh.ch
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2019
• Completion date: December 31, 2021