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

NCT05949567 | Recruiting

• 1 other identifier: APHP230769
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Urodynamic Exam; Neurologic Disorder

Keywords

Urodynamic exam; detrusor overactivity; positon

Outcome Measures

Primary Outcomes (1)

• concordance diagnosis of detrusor overactivity between lying and sitting position

  Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic

  24 months

Secondary Outcomes (3)

• position influence on the overactive detrusor gravity between the 2 positions

  24 months

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

  24 months

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

  24 months

Study Arms (2)

Lying position first - then sitting position

EXPERIMENTAL

Other: urodynamic exam in sitting and lying position

Sitting position first - then lying position

EXPERIMENTAL

Other: urodynamic exam in sitting and lying position

Interventions

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)

Lying position first - then sitting position; Sitting position first - then lying position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Physical and Rehabilitation Medicine Pitié Salpêtrière Hospital

Paris, France, 75013, France

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases; Urinary Bladder, Overactive

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: April 2, 2024
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 2, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)