Uronephrological Complications Risk Factors in Spinal Dysraphism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individualisation of uronephrological complications risk factors.
- Who it may be relevant to
- Registry conditions: Spinal Dysraphism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism
Overview
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.
Detailed description
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.
Outpatient examinations (urinary ultrasound, urethrocystography, anorectal manometry, defecography blood test with serum creatinine, glycemia, TSH, lipids) will be collected at the next consultation.
Patients' participation will last 12 months maximum (time period between the one-day hospitalization (inclusion) and the follow up consultation where the outpatients' examinations results will be recorded).
A better understanding of pelvic dysfunctions, according to neurological systematization and type of spinal dysraphism, will help to focus the evaluation and therapeutic managements on patients with spinal dysraphism at risk of uronephrological complications.
Interventions
- Other Individualisation of uronephrological complications risk factors
description of pelvic disorders in terms of clinical presentation, electrophysiology/urodynamics/anorectal manometry patterns, urethrocystography/urinary ultrasound/defecography results and urinary complications (infections, vesicoureteral reflux), depending on the dysraphim's type and level of injury and to correlate these parameters to the uronephrological risk factors and complications recorded.
Primary outcome measures
- sexual dysfunctions in term of spinal dysraphisms [Time frame: 1 day]
- patient quality of life [Time frame: 1 day]
- Urinary disorders [Time frame: 1 day]
- cognitive disorders [Time frame: 1 day]
- pelvic disorders description thanks to exams [Time frame: 1 day]
Secondary outcome measures (1)
- urinary complications [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- language barrier with non-understanding of French language,
- other neurologic pathologies except syringomyelia, Chiari malformation or hydrocephalus who are often associated to spinal dysraphism.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Tenon hospital — Paris
Identifiers
NCT: NCT05718440 · APHP221008