Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population - a Concordance Study Between Lying and Sitting Position
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- concordance diagnosis of detrusor overactivity between lying and sitting position
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Opposition to the performance of a Urodynamic exam as part of treatment
研究组 & 干预措施
Lying position first - then sitting position
干预措施: urodynamic exam in sitting and lying position (Other)
Sitting position first - then lying position
干预措施: urodynamic exam in sitting and lying position (Other)
结局指标
主要结局
concordance diagnosis of detrusor overactivity between lying and sitting position
时间窗: 24 months
Measurement concordance of detrusor pressures using the intraclass correlation coefficient statistic
次要结局
- comparison of the distribution of detrusor overactivity diagnoses according to position.(24 months)
- Evaluation of the diagnosis quality of the detrusor overactivity between the 2 position(24 months)
- position influence on the overactive detrusor gravity between the 2 positions(24 months)