Spinal DysraphismRUDNCT05718440
Uronephrological Complications Risk Factors in Spinal Dysraphism
An observational study of Spinal Dysraphism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Dysraphism
- What is being tested?
- Individualisation of uronephrological complications risk factors
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2023to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women over 18 years old with spinal dysraphism
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Tenon hospital
Paris, 75020
Maelys Teng, MD, MSc, 0156017954 ext. +33, maelys.teng@aphp.fr
Claire Hentzen, MD, MSc, 0156017954 ext. +33, claire.hentzen@aphp.fr
About this study
Official title: Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism
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.
Read the 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.
- Conditions
- Spinal Dysraphism
- Being tested
- Individualisation of uronephrological complications risk factors
- Keywords
- spinal dysraphism, uronephrological complications, risk factors, urinary dysfunction, bowel dysfunction, sexual dysfunction
- Medical subject headings
- Spinal Dysraphism, Intestinal Diseases, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualisation of uronephrological complications risk factorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patient with spinal dysraphism | Not described Receives: Other: Individualisation of uronephrological complications risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual dysfunctions in term of spinal dysraphisms
Sexual dysfonctions according the scale Men Health Sexual Questionnaire (MHSQ) score between 5 to 125 (no problem)
Measured: 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)
Measured: 1 day
Urinary disorders
Urinary Symptom Profile (USP) questionnaire (score between 0 (no problem) to 39)
Measured: 1 day
cognitive disorders
Montreal Cognitive Assessment (MOCA) scale (score between 0 to 30, normal between >=26)
Measured: 1 day
pelvic disorders description thanks to exams
urinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.
Measured: 1 day
Secondary outcomes (1)
urinary complications
number of infections, vesicoureteral reflux
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Nov 2023
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DysraphismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718440
- Sponsor's protocol ID
- APHP221008
- Acronym
- RUD
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism
- ClinicalTrials.gov ID
- NCT05718440
- Acronym / sponsor ID
- RUD / APHP221008
- Conditions
- Spinal Dysraphism
- Keywords
- spinal dysraphism, uronephrological complications, risk factors, urinary dysfunction, bowel dysfunction, sexual dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with spinal dysraphism | – | Other: Individualisation of uronephrological complications risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over 18 years old with spinal dysraphism
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- language barrier with non-understanding of French language,
- other neurologic pathologies except syringomyelia, Chiari malformation or hydrocephalus who are often associated to spinal dysraphism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualisation of uronephrological complications risk factorsdescription 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. | Other | patient with spinal dysraphism |
Primary outcome
sexual dysfunctions in term of spinal dysraphisms
Time frame: 1 day
Sexual dysfonctions according the scale Men Health Sexual Questionnaire (MHSQ) score between 5 to 125 (no problem)
patient quality of life
Time frame: 1 day
questionnaire "Qualiveen" (quality of life linked to health) to be completed by patient (score between 0 (no problem) to 4)
Urinary disorders
Time frame: 1 day
Urinary Symptom Profile (USP) questionnaire (score between 0 (no problem) to 39)
cognitive disorders
Time frame: 1 day
Montreal Cognitive Assessment (MOCA) scale (score between 0 to 30, normal between >=26)
pelvic disorders description thanks to exams
Time frame: 1 day
urinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.
1 secondary outcome
urinary complications
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Dysraphism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maelys Teng, MD, MSc (0156017954, maelys.teng@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual dysfunctions in term of spinal dysraphisms (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.