Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children

NCT ID: NCT03339609

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Urinary Tract Symptoms Urologic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate uroflow/EMG testing

Participants performed two direct repetitions of uroflowmetry in combination with EMG.

Uroflow/EMG

Intervention Type DIAGNOSTIC_TEST

Uroflow measurement with superficial EMG testing of the pelvic floor

US

Intervention Type DIAGNOSTIC_TEST

Ultrasound of post void residual urine

uroflow measurement beforehand

Participants performed a preceding measurement of isolated uroflowmetry, followed by two randomized measurements of either isolated uroflowmetry or uroflowmetry with EMG.

Uroflow

Intervention Type DIAGNOSTIC_TEST

Isolated uroflow measurement

Uroflow/EMG

Intervention Type DIAGNOSTIC_TEST

Uroflow measurement with superficial EMG testing of the pelvic floor

US

Intervention Type DIAGNOSTIC_TEST

Ultrasound of post void residual urine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Uroflow

Isolated uroflow measurement

Intervention Type DIAGNOSTIC_TEST

Uroflow/EMG

Uroflow measurement with superficial EMG testing of the pelvic floor

Intervention Type DIAGNOSTIC_TEST

US

Ultrasound of post void residual urine

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Normal development

Exclusion Criteria

* (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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/766

Identifier Type: -

Identifier Source: org_study_id