Clinical trial NCT05718440: Uronephrological Complications Risk Factors in Spinal Dysraphism
Official title: Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Dysraphism
Keywords: spinal dysraphism
uronephrological complications
risk factors
urinary dysfunction
bowel dysfunction
sexual dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women over 18 years old with spinal dysraphism

Brief summary: 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.

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.

Primary outcomes:
measure: sexual dysfunctions in term of spinal dysraphisms
timeFrame: 1 day
measure: patient quality of life
timeFrame: 1 day
measure: Urinary disorders
timeFrame: 1 day
measure: cognitive disorders
timeFrame: 1 day
measure: pelvic disorders description thanks to exams
timeFrame: 1 day
Secondary outcomes:
measure: urinary complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Tenon hospital
Study officials:
References: