Lower Urinary Tract SymptomsNCT03339609
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
An observational study of Lower Urinary Tract Symptoms and Urologic Diseases, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Urologic Diseases
- What is being tested?
- Uroflow, Uroflow/EMG and US
- How many people
- 83 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Jun 2017
- Phase
- Observational
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: continent children with normal development: community sample
Who may be able to join
- Normal development
Who cannot join
- (Recurrent) urinary tract infections
- LUTS which interfered with daily life
- Fecal incontinence
- History of genitourinary or renal surgery
- Medication for incontinence during the last 3 months
- Pelvic reeducation during the last 6 months
- Neurologic problems influencing continence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micturition Reeductation in Children With Cerebral Palsy: Uroflow/EMG Measurement in Healthy Children
Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate diagnosis. In regard to this, the International Continence Society indicated that the addition of pelvic floor electromyography might increase the accuracy of this assessment. Despite this recommendation, uroflowmetry in combination with electromyography has not been conducted in a healthy population.
The initial objective of this study was to examine whether adding electromyography to standard uroflowmetry in a healthy paediatric population would change the representation of parameters, especially of voiding patterns. In addition, the influence of several factors on uroflow parameters was analysed to complement current literature.
- Conditions
- Lower Urinary Tract Symptoms, Urologic Diseases
- Being tested
- Uroflow, Uroflow/EMG, US
- Medical subject headings
- Lower Urinary Tract Symptoms, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroflowDiagnostic test
Isolated uroflow measurement
Uroflow/EMGDiagnostic test
Uroflow measurement with superficial EMG testing of the pelvic floor
USDiagnostic test
Ultrasound of post void residual urine
| Study group | Role | What they receive |
|---|---|---|
| Immediate uroflow/EMG testing | Participants performed two direct repetitions of uroflowmetry in combination with EMG. Receives: Diagnostic Test: Uroflow/EMG; Diagnostic Test: US | |
| uroflow measurement beforehand | Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG. Receives: Diagnostic Test: Uroflow; Diagnostic Test: Uroflow/EMG; Diagnostic Test: US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uroflow curve pattern - Clinical assessment
Interpretation by pediatric urologist
Measured: 2017
Uroflow curve pattern - Mathematical assessment
Interpretation using Flow index methodology
Measured: 2017
Secondary outcomes (4)
Maximal flow
Qmax (millilitres/seconds)
Measured: 2017
post-void residual urine
millilitres
Measured: 2017
voiding time
seconds
Measured: 2017
voided volume
millilitres
Measured: 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study startSep 2014
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339609
- Sponsor's protocol ID
- 2011/766
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micturition Reeductation in Children With Cerebral Palsy: Uroflow/EMG Measurement in Healthy Children
- ClinicalTrials.gov ID
- NCT03339609
- Acronym / sponsor ID
- 2011/766
- Conditions
- Lower Urinary Tract Symptoms, Urologic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- Sep 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Nov 2017 (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.
Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate diagnosis. In regard to this, the International Continence Society indicated that the addition of pelvic floor electromyography might increase the accuracy of this assessment. Despite this recommendation, uroflowmetry in combination with electromyography has not been conducted in a healthy population.
The initial objective of this study was to examine whether adding electromyography to standard uroflowmetry in a healthy paediatric population would change the representation of parameters, especially of voiding patterns. In addition, the influence of several factors on uroflow parameters was analysed to complement current literature.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate uroflow/EMG testing | – | Diagnostic Test: Uroflow/EMG, Diagnostic Test: USParticipants performed two direct repetitions of uroflowmetry in combination with EMG. |
| uroflow measurement beforehand | – | Diagnostic Test: Uroflow, Diagnostic Test: Uroflow/EMG, Diagnostic Test: USParticipants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- continent children with normal development: community sample
Key inclusion criteria (1 listed)
- Normal development
Key exclusion criteria (7 listed)
- (Recurrent) urinary tract infections
- LUTS which interfered with daily life
- Fecal incontinence
- History of genitourinary or renal surgery
- Medication for incontinence during the last 3 months
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 |
|---|---|---|
| UroflowIsolated uroflow measurement | Diagnostic test | uroflow measurement beforehand |
| Uroflow/EMGUroflow measurement with superficial EMG testing of the pelvic floor | Diagnostic test | Immediate uroflow/EMG testing, uroflow measurement beforehand |
| USUltrasound of post void residual urine | Diagnostic test | Immediate uroflow/EMG testing, uroflow measurement beforehand |
Primary outcome
Uroflow curve pattern - Clinical assessment
Time frame: 2017
Interpretation by pediatric urologist
Uroflow curve pattern - Mathematical assessment
Time frame: 2017
Interpretation using Flow index methodology
4 secondary outcomes
Maximal flow
Time frame: 2017
post-void residual urine
Time frame: 2017
voiding time
Time frame: 2017
voided volume
Time frame: 2017
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 13 Nov 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Urologic Diseases, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 7 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 13 Nov 2017. 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 Belgium. 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?
Uroflow curve pattern - Clinical assessment (time frame: 2017). 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 13 Nov 2017.