Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population

Neurologic Disorder Clinical Trial

— Cysto-position  

Official title:

Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population - a Concordance Study Between Lying and Sitting Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949567
• Other study ID #: APHP230769
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: April 2, 2026

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1st consultation (selection - D-15):

• Targeted questioning of disorders, completion of USP self-questionnaire, and UPDRS or EDSS scales as part of care.

• Verification of ultrasound results (for men).

• Schedule Urodynamic Assessment as part of treatment.

• Verification of eligibility criteria

• Partial information of the patient (or relative/guardian/guardian if applicable) to limit bias, and a period of reflection prior to the urodynamic test to collect consent.

On the day of the Urodynamic Assessment (D0):

• Written, free and informed consent.

• Data collection by a physician trained in the study,

• Randomization of patient to determine starting position (lying or sitting) for urodynamic assessment (via CleanWeb).

• Urodynamic assessment according to ICS recommendations, with constant filling speed over the 2 fillings (50 ml/min), water filling - Laborie machine - T-Doc system in both positions in the order defined by randomization, and printout of curves.

• Entry of socio-demographic data.

• Curves reread by a doctor who had not performed the examination and who did not know the patient or the starting position (single blind).

• Completion of the paper file by the physician reading the curves, with the following data for position 1 and position 2:

• Volume at B1 and B3 (in ml)

• Basal bladder pressure (cm / H2O)

• Occurrence of CNID or mictional reflex arc (diagnosis of detrusor overactivity)

• Volume of leakage or 1st NIDC (Uninhibited Detrusor Contraction) (ml) or

• Bladder pressure at leakage (cm / H2O)

• Maximum bladder pressure (cm / H2O)

• Paper data entry on Excel database by a trained investigator declared on the study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 2, 2026
• Est. primary completion date: April 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Affiliated with a social security scheme (excluding AME).

• Free and informed written consent

Exclusion Criteria:

• Opposition to the performance of a Urodynamic exam as part of treatment

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder

Intervention

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)

Locations

Country	Name	City	State
France	Physical and Rehabilitation Medicine Pitié Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance diagnosis of detrusor overactivity between lying and sitting position	Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months