Assessing risk factors for urinary and bowel issues in spinal dysraphism
Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism
This study is trying to find out what causes urinary and bowel problems in adults with spinal dysraphism to help improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05718440 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify specific clinical and paraclinical patterns of pelvic disorders, such as urinary, bowel, and sexual dysfunctions, in adults with spinal dysraphism. Patients over 18 years old will be evaluated during a one-day hospitalization, where their medical history, treatments, and characteristics of pelvic disorders will be recorded. The study seeks to determine the prognosis of symptoms and the risk of complications based on the type and level of dysraphism. By identifying at-risk patients, the study aims to provide targeted evaluations and care to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years old diagnosed with spinal dysraphism who experience urinary, bowel, or sexual dysfunction.
Not a fit: Patients with other neurologic pathologies, except for those commonly associated with spinal dysraphism, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and management of pelvic disorders in patients with spinal dysraphism, ultimately improving their quality of life.
How similar studies have performed: While this study addresses a specific aspect of spinal dysraphism, similar observational studies have shown success in identifying risk factors for complications in related conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- Tenon hospital — Paris, France (Recruiting)
Study contacts
- Study coordinator: Maelys Teng, MD, MSc
- Email: maelys.teng@aphp.fr
- Phone: 0156017954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.