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NCT Number: NCT05949567

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

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.

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Key information

Conditions

Urodynamic Exam Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurologic Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical and Rehabilitation Medicine Pitié Salpêtrière Hospital

Paris, France, 75013

Location status: Recruiting

Location contact

Bertrand M PICHON, MD

CONTACT

[email protected]

142161047 ext. +33

Bertrand M PICHON, MD

PRINCIPAL_INVESTIGATOR

Helene Ms Robert, MD

CONTACT

[email protected]

142161137 ext. +33

Matthieu M GRASLAND, MD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urodynamic exam in sitting and lying position

Other

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)

Primary outcomes

  1. concordance diagnosis of detrusor overactivity between lying and sitting position

    Time frame: 24 months

    Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic

Secondary outcomes

  1. position influence on the overactive detrusor gravity between the 2 positions

    Time frame: 24 months

    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.

  2. Evaluation of the diagnosis quality of the detrusor overactivity between the 2 position

    Time frame: 24 months

    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.

  3. comparison of the distribution of detrusor overactivity diagnoses according to position.

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Cysto-position

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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