Spina BifidaNCT06725745
A Collaboration Between the EAU-ESPU Pediatric Urology Guidelines and the IFSBH
An observational study of Spina Bifida, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Children with spina bifida require care from various medical and paramedical specialists throughout their life. The availability and organization of the care needed differs between the European countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Survey
- How many people
- 281 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with spina bifida who are approached by their representative organizations
Who may be able to join
- Must have spina bifida
- Must be able to complete the digital survey, with help of caregivers allowed.
- Speak one of the nine available languages:
- English,
- Spanish,
- German,
Show all 12Show fewer
- Italian,
- French,
- Danish,
- Greek,
- Turkish,
- Dutch
Who cannot join
- Does not have spina bifida
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Patient Centered Urological Care for Spina Bifida: a Collaboration Between the EAU-ESPU Pediatric Urology Guidelines Panel and the IFSBH.
Children with spina bifida require care from various medical and paramedical specialists throughout their life. The availability and organization of the care needed differs between the European countries. The EAU and IFSBH are both organizations with the aim to improve patient care and clinical outcomes for children with spina bifida.
The investigators have set up a collaboration to evaluate the differences in organization of care and clinical treatment received and how this affects outcomes with regard to quality of life and sexuality.
Read more
A digital survey has been constructed which will be distributed among children and adolescents with spina bifida and their caregivers. The IFSBH and national patient organizations will send out invitations to their members. Children and adolescents from 8 - 18 years of age with spina bifida are eligible for inclusion.
The survey includes a primary survey developed in collaboration between panel members of the EAU pediatric urology guidelines and patient representatives. The second part includes validated questionnaires to evaluate Quality of life with the QUALAS and sexual function with the IIEF-5/FSFI-6 for boys/girls respectively.
Primary outcome will be the quality of life in children and adolescents with spina bifida. The team will evaluate if their demographic differences influence the quality of life and if differences are seen between the different European countries. Secondary outcomes include differences in sexual function, organization of care, treatment received, treatment options available, with also a focus on differences between the different European countries.
The results of this survey will be evaluated and interpreted within a sounding board group consisting of children/adolescents/adults with spina bifida, patient representatives from IFSBH and panel members of the EAU Pediatric Urology guidelines panel. Finally, the interpreted results will be used to update the EAU Pediatric Urology guidelines to make these more patient centered.
There are no known risks of participating in the study given the fact that participation includes only completion of questionnaires and data about standard of care. Furthermore, the study is completely voluntary and the results will be completely anonymous.
Read the detailed description
Introduction and rationale Children with spina bifida require care from various medical and paramedical specialists throughout their life. The availability and organization of the care needed differs between the European countries. It can be expected that this variety results in differences in outcome of care.
Children with spina bifida have stated that for future research they feel it is important that quality of life and sexuality are investigated.
The EAU Pediatric Urology guidelines panel wants to ensure that patients with spina bifida receive the best possible care based on the best available clinical evidence. Additionally, this team wants to improve the clinical guidelines by including patients perspectives. The IFSBH represents patients with spina bifida and values the promotion and protection of the human rights of patients with spina bifida thereby improving quality of life.
Together with the IFSBH the investigators have set up a collaboration to investigate how the team can make the guidelines more patient centered and thereby improve quality of care and quality of life.
For this aim the investigators have developed a survey to evaluate the current organization of care, demographic features and received treatment. The outcome of this survey will show the exact differences in care between European countries. The investigators have included two validated questionnaires to measure the effect this has on quality of life and sexuality. The information gathered will be used to adapt the clinical EAU Pediatric Urology guidelines.
Objective(s) The main objective is to improve the quality of life of patients with spina bifida by updating the guidelines according to the differences found in care and how this impacts patients outcomes.
The team will evaluate the difference in organization of care between different European countries based on the outcomes of the primary survey. The baseline quality of life and sexuality reported will be evaluated with the QUALAS and the IIEF-5/FSFI-6 questionnaires. The investigators will then explore the relationship between how care is organized and how this affects quality of life and sexuality. The results of this study will be used to update the EAU Pediatric Urology clinical guidelines. Also, it will highlight the direction for future research to improve patients care and thereby quality of life and/or sexuality, which patients with spina bifida have stated they themselves find important.
Methods This digital survey includes a primary survey regarding basic demographic features, medical treatment and organization of care. This survey was constructed by the EAU guidelines panel and the IFSBH patient representatives. The second part of the digital survey includes two validated questionnaires. The QUALAS is a validated questionnaire regarding quality of life in patients with spina bifida. There are two different versions for the ages 8-12 and 13-18 years. To evaluate sexuality the IIEF-5 (for boys) and the FSFI-6 (for girls) are used. These questionnaires are validated and are used in patients with spina bifida to evaluate sexual function as standard of care. Only children aged 13 years or older will be asked if they want to answer questions about sexuality and if they answer yes they will be asked for which gender they want to answer questions about their sexuality. After this they'll get the IIEF-5 or FSFI-6 questionnaire.
This digital survey is available in nine languages: English, Spanish, German, Italian, French, Danish, Greek, Turkish and Dutch.
The link to surveymonkey will be distributed by the IFSBH and local patient organizations among their members.
After the data have been collected, the general results of the survey will be evaluated and interpreted with a sounding board group. When patients participate with the digital survey they will not be involved in the sounding group. This sounding board group will consist of children/adolescents/adults with spina bifida who are representatives from the patient organization IFSBH and panel members of the EAU. This sounding board group will meet for a day. Finally, the results will be used to update the EAU Pediatric Urology guidelines.
- Conditions
- Spina Bifida
- Being tested
- Survey
- Keywords
- patient involvement, organization of care
- Medical subject headings
- Spinal Dysraphism, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey containing a primary survey regarding basic demographic features, medical treatment and organization of care and two validated questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| People with spina bifida | People with spina bifida are approached through representative organizations by email to complete a digital survey at 1 timepoint. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUALAS score
Score derived from the Quality of Life Assessment in Spina Bifida (QUALAS) survey Scores range from 0-100 with higher scores indicating better quality of life
Measured: 6 months
Secondary outcomes (3)
Demographic parameters
Gender, age, medication use, catheter use, organization of care
Measured: 6 months
IIEF score
Score derived from the International Index of Erectile Function (IIEF) survey Scores range from 1-25 with higher scores indicating better erectile function
Measured: 6 months
FSFI score
Score derived from the Female Sexual Function Index (FSFI) survey. Scores range from 2-30 with higher scores indicating better sexual function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start30 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisette 't Hoen, Erasmus Medical Center
- Investigators
- Lisette 't Hoen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725745
- Sponsor's protocol ID
- EMCSophia1
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
't Hoen L, Radmayr C, Gnech M, Bezuidenhout C, van Uitert A, Castagnetti M, Burgu B, O'Kelly F, Quaedackers J, Rawashdeh Y, Silay S, Bujons A, Bogaert G, Pakkasjarvi N, Skott M, Kennedy U, Banuelos Marco B, Roozen S. Assessing Patient Centered Urological Care for Spina Bifida: A Collaboration Between the European Association of Urology-European Society for Pediatric Urology (EAU-ESPU) Pediatric Urology Guidelines Panel and the International Federation for Spina Bifida and Hydrocephalus (IFSBH). Neurourol Urodyn. 2026 Jul 27. doi: 10.1002/nau.70386. Online ahead of print.
PubMed 42504464
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Centered Urological Care for Spina Bifida: a Collaboration Between the EAU-ESPU Pediatric Urology Guidelines Panel and the IFSBH.
- ClinicalTrials.gov ID
- NCT06725745
- Acronym / sponsor ID
- EMCSophia1
- Conditions
- Spina Bifida
- Keywords
- patient involvement, organization of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Dec 2024 (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.
Children with spina bifida require care from various medical and paramedical specialists throughout their life. The availability and organization of the care needed differs between the European countries. The EAU and IFSBH are both organizations with the aim to improve patient care and clinical outcomes for children with spina bifida.
The investigators have set up a collaboration to evaluate the differences in organization of care and clinical treatment received and how this affects outcomes with regard to quality of life and sexuality.
A digital survey has been constructed which will be distributed among children and adolescents with spina bifida and their caregivers. The IFSBH and national patient organizations will send out invitations to their members. Children and adolescents from 8 - 18 years of age with spina bifida are eligible for inclusion.
The survey includes a primary survey developed in collaboration between panel members of the EAU pediatric urology guidelines and patient representatives. The second part includes validated questionnaires to evaluate Quality of life with the QUALAS and sexual function with the IIEF-5/FSFI-6 for boys/girls respectively.
Primary outcome will be the quality of life in children and adolescents with spina bifida. The team will evaluate if their demographic differences influence the quality of life and if differences are seen between the different European countries. Secondary outcomes include differences in sexual function, organization of care, treatment received, treatment options available, with also a focus on differences between the different European countries.
The results of this survey will be evaluated and interpreted within a sounding board group consisting of children/adolescents/adults with spina bifida, patient representatives from IFSBH and panel members of the EAU Pediatric Urology guidelines panel. Finally, the interpreted results will be used to update the EAU Pediatric Urology guidelines to make these more patient centered.
There are no known risks of participating in the study given the fact that participation includes only completion of questionnaires and data about standard of care. Furthermore, the study is completely voluntary and the results will be completely anonymous.
Detailed description
Introduction and rationale Children with spina bifida require care from various medical and paramedical specialists throughout their life. The availability and organization of the care needed differs between the European countries. It can be expected that this variety results in differences in outcome of care.
Children with spina bifida have stated that for future research they feel it is important that quality of life and sexuality are investigated.
The EAU Pediatric Urology guidelines panel wants to ensure that patients with spina bifida receive the best possible care based on the best available clinical evidence. Additionally, this team wants to improve the clinical guidelines by including patients perspectives. The IFSBH represents patients with spina bifida and values the promotion and protection of the human rights of patients with spina bifida thereby improving quality of life.
Together with the IFSBH the investigators have set up a collaboration to investigate how the team can make the guidelines more patient centered and thereby improve quality of care and quality of life.
For this aim the investigators have developed a survey to evaluate the current organization of care, demographic features and received treatment. The outcome of this survey will show the exact differences in care between European countries. The investigators have included two validated questionnaires to measure the effect this has on quality of life and sexuality. The information gathered will be used to adapt the clinical EAU Pediatric Urology guidelines.
Objective(s) The main objective is to improve the quality of life of patients with spina bifida by updating the guidelines according to the differences found in care and how this impacts patients outcomes.
The team will evaluate the difference in organization of care between different European countries based on the outcomes of the primary survey. The baseline quality of life and sexuality reported will be evaluated with the QUALAS and the IIEF-5/FSFI-6 questionnaires. The investigators will then explore the relationship between how care is organized and how this affects quality of life and sexuality. The results of this study will be used to update the EAU Pediatric Urology clinical guidelines. Also, it will highlight the direction for future research to improve patients care and thereby quality of life and/or sexuality, which patients with spina bifida have stated they themselves find important.
Methods This digital survey includes a primary survey regarding basic demographic features, medical treatment and organization of care. This survey was constructed by the EAU guidelines panel and the IFSBH patient representatives. The second part of the digital survey includes two validated questionnaires. The QUALAS is a validated questionnaire regarding quality of life in patients with spina bifida. There are two different versions for the ages 8-12 and 13-18 years. To evaluate sexuality the IIEF-5 (for boys) and the FSFI-6 (for girls) are used. These questionnaires are validated and are used in patients with spina bifida to evaluate sexual function as standard of care. Only children aged 13 years or older will be asked if they want to answer questions about sexuality and if they answer yes they will be asked for which gender they want to answer questions about their sexuality. After this they'll get the IIEF-5 or FSFI-6 questionnaire.
This digital survey is available in nine languages: English, Spanish, German, Italian, French, Danish, Greek, Turkish and Dutch.
The link to surveymonkey will be distributed by the IFSBH and local patient organizations among their members.
After the data have been collected, the general results of the survey will be evaluated and interpreted with a sounding board group. When patients participate with the digital survey they will not be involved in the sounding group. This sounding board group will consist of children/adolescents/adults with spina bifida who are representatives from the patient organization IFSBH and panel members of the EAU. This sounding board group will meet for a day. Finally, the results will be used to update the EAU Pediatric Urology guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with spina bifida | – | Other: SurveyPeople with spina bifida are approached through representative organizations by email to complete a digital survey at 1 timepoint. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with spina bifida who are approached by their representative organizations
Key inclusion criteria (12 listed)
- Must have spina bifida
- Must be able to complete the digital survey, with help of caregivers allowed.
- Speak one of the nine available languages:
Key exclusion criteria (1 listed)
- Does not have spina bifida
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 |
|---|---|---|
| SurveySurvey containing a primary survey regarding basic demographic features, medical treatment and organization of care and two validated questionnaires. | Other | People with spina bifida |
Primary outcome
QUALAS score
Time frame: 6 months
Score derived from the Quality of Life Assessment in Spina Bifida (QUALAS) survey Scores range from 0-100 with higher scores indicating better quality of life
3 secondary outcomes
Demographic parameters
Time frame: 6 months
IIEF score
Time frame: 6 months
FSFI score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 42504464't Hoen L, Radmayr C, Gnech M, Bezuidenhout C, van Uitert A, Castagnetti M, Burgu B, O'Kelly F, Quaedackers J, Rawashdeh Y, Silay S, Bujons A, Bogaert G, Pakkasjarvi N, Skott M, Kennedy U, Banuelos Marco B, Roozen S. Assessing Patient Centered Urological Care for Spina Bifida: A Collaboration Between the European Association of Urology-European Society for Pediatric Urology (EAU-ESPU) Pediatric Urology Guidelines Panel and the International Federation for Spina Bifida and Hydrocephalus (IFSBH). Neurourol Urodyn. 2026 Jul 27. doi: 10.1002/nau.70386. Online ahead of print.
- 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. This study is not recruiting at the moment.
Lisette 't Hoen, MD, PhD principal investigator
Erasmus Medical Center
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 Spina Bifida, run by Erasmus Medical Center at 1 site in Netherlands.
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 12 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUALAS score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06725745, which also lists 1 linked publication.
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 10 Dec 2024.