Incontinence, UrinaryWBVTNCT04737447
Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial
A study testing Whole Body Vibration Training in people with Incontinence, Urinary, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Urinary
- What is being tested?
- Whole Body Vibration Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Incontinence, Urinary
- Being tested
- Whole Body Vibration Training
- Keywords
- Whole Body Vibration Training (WBVT), Incontinence in children
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration TrainingDevice
Also called Galileo 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Whole Body Vibration Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start15 Jan 2019
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Hoelscher, University Children's Hospital, Zurich
- Investigators
- Hoelscher, Principal investigator, Consultant in Pediatric Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737447
- Sponsor's protocol ID
- 10642
- Acronym
- WBVT
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Training in the Treatment for Children's Incontinence - a Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT04737447
- Acronym / sponsor ID
- WBVT / 10642
- Conditions
- Incontinence, Urinary
- Keywords
- Whole Body Vibration Training (WBVT), Incontinence in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | Active comparator | Device: Whole Body Vibration Training20 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. |
| Group B (Study Group) | Active comparator | Device: Whole Body Vibration Training20 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body Vibration TrainingAlso: Galileo TrainingGalileo® 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. | Device | Group A (Control Group), Group B (Study Group) |
Primary outcome
Change of Dysfunctional Voiding and Incontinence Score (DVISS)
Time frame: Change of DVISS between Baseline and Post-interventional at 12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention
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 Revised Urinary Incontinence Scale (RUIS)
Time frame: Change of RUIS between Baseline and post-interventional (12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention)
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.
2 secondary outcomes
Change of Urinary flow measurements (UF)
Time frame: 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)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoelscher principal investigator
Consultant in Pediatric Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration Training in people with Incontinence, Urinary, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Dysfunctional Voiding and Incontinence Score (DVISS) (time frame: Change of DVISS between Baseline and Post-interventional at 12 weeks after Beginning of Intervention, 24 and 48 weeks after Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.