A Collaboration Between the EAU-ESPU Pediatric Urology Guidelines and the IFSBH

NCT06725745 | Completed

• 1 other identifier: EMCSophia1
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spina Bifida

Keywords

patient involvement; organization of care

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (3)

• Demographic parameters

  6 months

• IIEF score

  6 months

• FSFI score

  6 months

Study Arms (1)

People with spina bifida

People with spina bifida are approached through representative organizations by email to complete a digital survey at 1 timepoint.

Other: Survey

Interventions

Survey OTHER

Survey containing a primary survey regarding basic demographic features, medical treatment and organization of care and two validated questionnaires.

People with spina bifida

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with spina bifida who are approached by their representative organizations

You may qualify if:

• 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,
• Italian,
• French,
• Danish,
• Greek,
• Turkish,
• Dutch

You may not qualify if:

• Does not have spina bifida

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Spinal Dysraphism; Patient Participation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lisette 't Hoen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: June 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)