An interventional study of urodynamic exam in sitting and lying position in Urodynamic Exam and Neurologic Disorder, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized techniques, and very few neurological patients. It seems appropriate to focus on neurological patients and to examine the influence of position on the detection of detrusor overactivity in these patients.
The point here is to reexamine the ICS recommendations, which are not designed for neurological patients. Indeed, many patients suffering from Multiple Sclerosis (MS) or Parkinson's disease are unable to sit or stand for the duration of the urodynamic examination. The investigators would like to assess whether exploring sphincter disorders in the supine position is still interpretable.
This would enable us to define ICS good practice recommendations for a neurological population.
1st consultation (selection - D-15):
On the day of the Urodynamic Assessment (D0):
757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.
This study's planned enrollment of 160 is above the median of 55 across 495 interventional studies indexed under Nervous System Diseases.
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Exclusion Criteria:
Other: urodynamic exam in sitting and lying position
Other: urodynamic exam in sitting and lying position
Urodynamic exam with 1st filling in sitting or lying position. Then , during the same procedure, a second filling in the opposite position of the 1st filling (lying or sitting)
concordance diagnosis of detrusor overactivity between lying and sitting position
Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic
Time frame: 24 months
position influence on the overactive detrusor gravity between the 2 positions
Measurement of the concordance of detrusor overactivity diagnostic gravities during urodynamic assessments, between those performed in the supine position and those performed in the seated position. Concordance will be assessed using Cohen's Kappa statistic.
Time frame: 24 months
Evaluation of the diagnosis quality of the detrusor overactivity between the 2 position
Measurement of the diagnostic quality of urodynamic testing performed in the supine position in neurological patients to detect detrusor activity, with the seated position being the gold standard: estimation of sensitivity and specificity.
Time frame: 24 months
comparison of the distribution of detrusor overactivity diagnoses according to position.
Measurement of the association between position during urodynamic assessment and diagnosis of detrusor overactivity: comparison of the distribution of diagnoses of detrusor overactivity according to position.
Time frame: 24 months
Plan to share: Yes — Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, National Commission for Computing and Liberties) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access criteria: Researchers who provide a methodologically sound proposal.
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