Health TrialsbyHealthPanel

Uronephrological Complications Risk Factors in Spinal Dysraphism

ConditionSpinal Dysraphism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

language barrier with non-understanding of French language,

other neurologic pathologies except syringomyelia, Chiari malformation or hydrocephalus who are often associated to spinal dysraphism.

Trial population

Men and women over 18 years old with spinal dysraphism

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Individualisation of uronephrological complications risk factors

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: patient with spinal dysraphism1 intervention

Trial outcomes

Primary outcomes

1

sexual dysfunctions in term of spinal dysraphisms

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

Time frame
1 day
2

patient quality of life

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

Time frame
1 day
3

Urinary disorders

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

Time frame
1 day
4

cognitive disorders

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

Time frame
1 day

Secondary outcomes

1

urinary complications

number of infections, vesicoureteral reflux

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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