Uronephrological Complications Risk Factors in Spinal Dysraphism

NCT05718440 | Recruiting

• 1 other identifier: APHP221008
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Dysraphism

Keywords

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

Outcome Measures

Primary Outcomes (5)

• sexual dysfunctions in term of spinal dysraphisms

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

  1 day

• patient quality of life

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

  1 day

• Urinary disorders

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

  1 day

• cognitive disorders

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

  1 day

• pelvic disorders description thanks to exams

  urinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.

  1 day

Secondary Outcomes (1)

• urinary complications

  1 day

Study Arms (1)

patient with spinal dysraphism

Other: Individualisation of uronephrological complications risk factors

Interventions

Individualisation of uronephrological complications risk factors OTHER

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.

patient with spinal dysraphism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women over 18 years old with spinal dysraphism

You may qualify if:

• 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

You may not qualify if:

• language barrier with non-understanding of French language,
• other neurologic pathologies except syringomyelia, Chiari malformation or hydrocephalus who are often associated to spinal dysraphism.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Tenon hospital

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism; Intestinal Diseases; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Maelys Teng, MD, MSc

CONTACT

0156017954; maelys.teng@aphp.fr

Claire Hentzen, MD, MSc

CONTACT

0156017954; claire.hentzen@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 8, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)