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临床试验/NCT05718440
NCT05718440招募中不适用

Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
cognitive disorders

研究概览

简要总结

Spinal dysraphism consist of congenital malformations resulting of abnormalities in the formation of neural tube and/or surrounding structures during embryogenesis. The aim of this study is to assess if there are specific clinical and paraclinical patterns of pelvic (urinary, bowel, sexual) disorders depending on the dysraphism's type and level of injury.

This description will help to determine a prognosis on symptoms and the risk of complication depending on the dysraphism's type and level of injury. It will provide targeted evaluation and cares: identifying patients who will be at risk of complications and needing acute monitoring or preventing cares on the symptoms' onset.

Pelvic disorders have an important impact on morbi-mortality (urinary dysfunction is the first cause of mortality in adults by renal failure or infection) and also on patients' quality of life.

详细描述

Spinal dysraphism consist of congenital malformations resulting of abnormalities in the formation of neural tube and/or surrounding structures during embryogenesis. The aim of this study is to assess if there are specific clinical and paraclinical patterns of pelvic (urinary, bowel, sexual) disorders depending on the dysraphism's type and level of injury.

This description will help to determine a prognosis on symptoms and the risk of complication depending on the dysraphism's type and level of injury. It will provide targeted evaluation and cares: identifying patients who will be at risk of complications and needing acute monitoring or preventing cares on the symptoms' onset.

Pelvic disorders have an important impact on morbi-mortality (urinary dysfunction is the first cause of mortality in adults by renal failure or infection) and also on patients' quality of life.

This is an observational descriptive study with prospective inclusions of patients over 18 years old with spinal dysraphism, evaluated for urinary, anorectal, sexual dysfunctions in a one-day hospitalization.

Inclusions will be recorded during this one-day hospitalization. On this day, patients will have a medical consultation and data concerning medical history, treatments, pelvic disorders' characteristics and physical examination will be recorded. They will answer questionnaires on pelvic dysfunctions, quality of life, anxiety and depression, cognitive disorders and self-catheterizations' adherence or difficulties. They will also undergo urodynamics. In case of peripheral neurological pattern, a perineal electrophysiology will be done with recording of bulbocavernosus reflex latency and somatosensory evoked potentials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women over 18 years old with spinal dysraphism,
  • urinary and/or bowel and/or sexual dysfunction,
  • evaluated in a one day consultation in a neuro-urology department.
  • Informed consent is required from the patient or his tutor/curator if he is under legal protection

排除标准

  • language barrier with non-understanding of French language,
  • other neurologic pathologies except syringomyelia, Chiari malformation or hydrocephalus who are often associated to spinal dysraphism.

结局指标

主要结局

cognitive disorders

时间窗: 1 day

Montreal Cognitive Assessment (MOCA) scale (score between 0 to 30, normal between \>=26)

sexual dysfunctions in term of spinal dysraphisms

时间窗: 1 day

Sexual dysfonctions according the scale Men Health Sexual Questionnaire (MHSQ) score between 5 to 125 (no problem)

Urinary disorders

时间窗: 1 day

Urinary Symptom Profile (USP) questionnaire (score between 0 (no problem) to 39)

pelvic disorders description thanks to exams

时间窗: 1 day

urinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.

patient quality of life

时间窗: 1 day

questionnaire "Qualiveen" (quality of life linked to health) to be completed by patient (score between 0 (no problem) to 4)

次要结局

  • urinary complications(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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