| NCT ID | NCT06723951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Spina Bifida |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-12-09 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale Patients with spina bifida often experience a decreased quality of life compared to patients without spina bifida. The Quality of Life Assessment for Spina Bifida (QUALAS) is a validated questionnaire to assess the quality of life in children, teenagers and adults with spina bifida, accounting for specific factors, such as bladder and bowel dysfunction. This questionnaire enables us to assess the current spina bifida related quality of life and identify if bladder and bowel dysfunction is of influence. Objective(s) To validate the Quality of Life Assessment for Spina Bifida in Children, Teenagers and Adults in Dutch. Study type A multicenter prospective validation cohort study. Study population Children aged 8 - 17 years and adults who are diagnosed with spina bifida. As a control group children aged 8 - 17 years and adults without spina bifida will be approached at the Ear-Nose-Throat (ENT) and paediatric clinics. Methods The main study parameter is the validation of the Dutch version of the questionnaire. Patients with spina bifida are asked to fill out the QUALAS at two time-points. They are also asked to fill out an extra questionnaire at two time-points, in order to validate the QUALAS. Children and adults in the control groups are asked to fill out the two questionnaires only once. Burden and risks No (extra) outpatient visit is required. The questions in the questionnaires are similar to the medical history during an outpatient visit. The burden is therefore minimal for these patients. Participation in this study will not influence patient treatment. Recruitment and consent Parents of children and children and adults who meet the inclusion criteria and none of the exclusion criteria will be informed orally about this study by their treating urologist during a regular visit. A patient information and consent form will be handed over to the parents and children over eight years of age and adults. Parents of children and children and adults at the ENT clinic will be approached by the local urologist for participation for this study. If they are willing to participate they will be asked to sign informed consent and fill out the questionnaire.
Eligibility Criteria
Inclusion Criteria: Patient group: * Male or female patients aged 8 -12 years (QUALAS-C) * Male or female patients aged 13 - 17 years (QUALAS-T) * Adult patients (QUALAS-A) * Has spina bifida * Adult or child and at least one parent fluent in the Dutch language * Signed informed consent Control group: * Male or female children aged 8 -12 years (QUALAS-C) * Male or female adolescents aged 13 - 17 years (QUALAS-T) * Adults (QUALAS-A) * Has no spina bifida * Adult or child and at least one parent fluent in the Dutch language * Signed informed consent Exclusion Criteria: * Has a neurogenic disease other than spina bifida * Has had surgery in the last month
Contact & Investigator
Lisette 't Hoen, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06723951 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Spina Bifida. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06723951 currently recruiting?
Yes, NCT06723951 is actively recruiting participants. Contact the research team at l.thoen@erasmusmc.nl for enrollment information.
Where is the NCT06723951 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT06723951 clinical trial?
NCT06723951 is sponsored by Erasmus Medical Center. The principal investigator is Lisette 't Hoen, MD, PhD at Erasmus Medical Center. The trial plans to enroll 300 participants.