Uronephrological Complications Risk Factors in Spinal Dysraphism

Recruiting

• Conditions: Spinal Dysraphism
• Interventions: Other: Individualisation of uronephrological complications risk factors

• Registration Number: NCT05718440
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-08
• Study Start: 2023-11-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with spinal dysraphism	Individualisation of uronephrological complications risk factors	-

Primary Outcome Measures

Name	Time	Method
cognitive disorders	1 day	Montreal Cognitive Assessment (MOCA) scale (score between 0 to 30, normal between \>=26)
sexual dysfunctions in term of spinal dysraphisms	1 day	Sexual dysfonctions according the scale Men Health Sexual Questionnaire (MHSQ) score between 5 to 125 (no problem)
Urinary disorders	1 day	Urinary Symptom Profile (USP) questionnaire (score between 0 (no problem) to 39)
pelvic disorders description thanks to exams	1 day	urinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.
patient quality of life	1 day	questionnaire "Qualiveen" (quality of life linked to health) to be completed by patient (score between 0 (no problem) to 4)

Secondary Outcome Measures

Name	Time	Method
urinary complications	1 day	number of infections, vesicoureteral reflux

Trial Locations

Locations (1)

Tenon hospital; 🇫🇷 Paris, France