Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population (Cysto-position)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Disorder; Urodynamic Exam
• Intervention / Treatment: Other: urodynamic exam in sitting and lying position

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Physical and Rehabilitation Medicine Pitié Salpêtrière Hospital
    • Contact: Bertrand M PICHON, MD; Phone Number: +33 142161047; Email: Bertrand.pichon@aphp.fr
    • Contact: Helene Ms Robert, MD; Phone Number: +33 142161137; Email: Helene.robert@aphp.fr
    • Sub-Investigator: Matthieu M GRASLAND, MD
    • Principal Investigator: Bertrand M PICHON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lying position first - then sitting 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)
Experimental: Sitting position first - then 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance diagnosis of detrusor overactivity between lying and sitting position	Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): April 2, 2026
• Study Completion (Estimated): April 2, 2026

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: detrusor overactivity; Urodynamic exam; positon
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nervous System Diseases
• Other Study ID Numbers: APHP230769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No