EnuresisNCT03399877
A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
A study testing Combining electromyography with uroflowmetry (group A), Uroflowmetry(Group B) and Uroflowmetry-Combining electromyography with uroflowmetry (Group C) in people with Enuresis, run by Yonsei University at 1 site in South Korea.
Trial summary
Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Enuresis
- What is being tested?
- Combining electromyography with uroflowmetry (group A), Uroflowmetry(Group B) and Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Dec 2017to Oct 2019
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1) children aged 5 to 11.9 who visit pediatric urology department for enuresis.
Who cannot join
- If children have experience of performing uroflowmetry or uroflowmetry-electromyography.
- If children do not cooperate on performing the test
- If enuresis is caused by neurological or anatomical problem.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Urology,
Seoul, 03722
Yong Seung Lee, MD, 82-2-2228-2310, asforthelord@yuhs.ac
About this study
Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test. Therefore, the investigators are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)
- Conditions
- Enuresis
- Being tested
- Combining electromyography with uroflowmetry (group A), Uroflowmetry(Group B), Uroflowmetry-Combining electromyography with uroflowmetry (Group C)
- Medical subject headings
- Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combining electromyography with uroflowmetry (group A)Biological
Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.
Uroflowmetry(Group B)Biological
Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.
Uroflowmetry-Combining electromyography with uroflowmetry (Group C)Biological
Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
| Study group | Role | What they receive |
|---|---|---|
| Combining electromygraphy with uroflowmetry | Active comparator | Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography Receives: Biological: Combining electromyography with uroflowmetry (group A) |
| Uroflowmetry | Active comparator | Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely. Receives: Biological: Uroflowmetry(Group B) |
| Uroflowmetry-Combining electromygraphy with uroflowmetry | Experimental | Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography. Receives: Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum flow rate(Qmax=cc/s)
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
Measured: One day
Secondary outcomes (3)
Uroflow curve pattern
Uroflow curve pattern: There are 5 uroflow curve patterns, bell-shaped, tower-shaped, interrupted-shaped, staccato-shaped and plateau shaped by uroflowmetry. The shape is determined by detrusor contractility and influenced by abdominal straining, coordination with the bladder outlet musculature and any distal anatomic obstruction.
Measured: One day
post void residual
post-void residual(cc): ultrasonographic bladder scan machines calculates bladder volume. PVR measurements in neurologically intact children are highly variable. PVR must be obtained immediately after voiding(<5min)
Measured: One day
synergy or dyssynergy between the bladder and the pelvic floor.
synergy or dyssynergy between the bladder and the pelvic floor is abstained by combining electromyography with uroflowmetry.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start4 Dec 2017
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnuresisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Children who meet the inclusion criteria and no exclusion criteria are assigned to perform one of the three test protocols in order of registration according to a computer gererated randomization list. Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again. Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry. Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399877
- Sponsor's protocol ID
- 4-2017-0842
- Status last verified
- Jan 2019
- First submitted
- 22 Dec 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
- ClinicalTrials.gov ID
- NCT03399877
- Acronym / sponsor ID
- 4-2017-0842
- Conditions
- Enuresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 17 Jan 2018 (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.
Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test. Therefore, the investigators are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Children who meet the inclusion criteria and no exclusion criteria are assigned to perform one of the three test protocols in order of registration according to a computer gererated randomization list. Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again. Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry. Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
| Arm | Type | Receives |
|---|---|---|
| Combining electromygraphy with uroflowmetry | Active comparator | Biological: Combining electromyography with uroflowmetry (group A)Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography |
| Uroflowmetry | Active comparator | Biological: Uroflowmetry(Group B)Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely. |
| Uroflowmetry-Combining electromygraphy with uroflowmetry | Experimental | Biological: Uroflowmetry-Combining electromyography with uroflowmetry (Group C)Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1) children aged 5 to 11.9 who visit pediatric urology department for enuresis.
Key exclusion criteria (3 listed)
- If children have experience of performing uroflowmetry or uroflowmetry-electromyography.
- If children do not cooperate on performing the test
- If enuresis is caused by neurological or anatomical problem.
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 |
|---|---|---|
| Combining electromyography with uroflowmetry (group A)Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again. | Biological | Combining electromygraphy with uroflowmetry |
| Uroflowmetry(Group B)Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry. | Biological | Uroflowmetry |
| Uroflowmetry-Combining electromyography with uroflowmetry (Group C)Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography. | Biological | Uroflowmetry-Combining electromygraphy with uroflowmetry |
Primary outcome
maximum flow rate(Qmax=cc/s)
Time frame: One day
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
3 secondary outcomes
Uroflow curve pattern
Time frame: One day
post void residual
Time frame: One day
synergy or dyssynergy between the bladder and the pelvic floor.
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combining electromyography with uroflowmetry (group A), Uroflowmetry(Group B) and Uroflowmetry-Combining electromyography with uroflowmetry (Group C) in people with Enuresis, run by Yonsei University at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Jan 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Seung Lee, MD (82-2-2228-2310, asforthelord@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum flow rate(Qmax=cc/s) (time frame: One day). 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 16 Jan 2019.