NCT05949567 Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population
| NCT ID | NCT05949567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Urodynamic Exam |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2027-04-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-04-02 with a primary completion date of 2027-04-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05949567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urodynamic Exam. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05949567 currently recruiting?
Yes, NCT05949567 is actively recruiting participants. Visit ClinicalTrials.gov or contact Assistance Publique - Hôpitaux de Paris to inquire about joining.
Where is the NCT05949567 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05949567 clinical trial?
NCT05949567 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 160 participants.