Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population (NCT05949567) | Clinical Trial Compass
RecruitingNot Applicable
Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population
France160 participantsStarted 2024-04-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
concordance diagnosis of detrusor overactivity between lying and sitting position