Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with MS or neurologically confirmed Parkinson's disease, with indication for urodynamic assessment - 1st assessment
Clinical overactive bladder syndrome with USP overactive bladder sub-score > or = 4 - Age ≥18 years
In men: no prostatic hypertrophy on ultrasonography
In women: no stress urinary incontinence (SUI); USP SUI subscore ≤ 2
Disqualifiers
Opposition to the performance of a Urodynamic exam as part of treatment
Trial design
Design model
Parallel
Treatments tested in this trial
urodynamic exam in sitting and lying position
Other interventionUrodynamic 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)
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Lying position first - then sitting positionExperimental treatment 1 intervention
Group B: Sitting position first - then lying positionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
concordance diagnosis of detrusor overactivity between lying and sitting position
Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic
Time frame
24 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov