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Uronephrological Complications Risk Factors in Spinal Dysraphism

Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05718440
Acronym
RUD
Enrollment
200
Registered
2023-02-08
Start date
2023-11-06
Completion date
2028-11-30
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Dysraphism

Keywords

spinal dysraphism, uronephrological complications, risk factors, urinary dysfunction, bowel dysfunction, sexual dysfunction

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.

Interventions

OTHERIndividualisation 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
sexual dysfunctions in term of spinal dysraphisms1 daySexual dysfonctions according the scale Men Health Sexual Questionnaire (MHSQ) score between 5 to 125 (no problem)
patient quality of life1 dayquestionnaire Qualiveen (quality of life linked to health) to be completed by patient (score between 0 (no problem) to 4)
Urinary disorders1 dayUrinary Symptom Profile (USP) questionnaire (score between 0 (no problem) to 39)
cognitive disorders1 dayMontreal Cognitive Assessment (MOCA) scale (score between 0 to 30, normal between \>=26)
pelvic disorders description thanks to exams1 dayurinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.

Secondary

MeasureTime frameDescription
urinary complications1 daynumber of infections, vesicoureteral reflux

Countries

France

Contacts

Primary ContactMaelys Teng, MD, MSc
maelys.teng@aphp.fr0156017954
Backup ContactClaire Hentzen, MD, MSc
claire.hentzen@aphp.fr0156017954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026