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Adult Bladder and Quality of Life Evaluation in Spina Bifida (ABLE-SB)
10 juni 2026 bijgewerkt door: Blayne Welk
Patient Reported Outcomes for Bladder Management Strategies in Young Adults With Spina Bifida
Spina bifida (SB) is a birth defect that affects the spine, often causing paralysis in the legs and problems with bladder and bowel control.
Managing these bladder issues is important, but different methods, like using a catheter or surgery, can impact a person's quality of life.
This study looks at how different bladder management methods affect the quality of life for young people with SB.
Researchers will ask people with SB to complete a survey about how they manage their bladder and how it impacts their daily lives.
The main goal is to find out if certain bladder management methods are associated with a better quality of life.
This information could help doctors make better treatment decisions and counsel young people living with SB.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
Spina bifida is a congenital defect of the spine where some of the spinal cord and its covering (meninges) are exposed through a gap in the lower back or sacrum; this often results in paralysis of the lower limbs.
The majority of spina bifida (SB) patients also have pelvic floor dysfunction (bladder, bowel, prolapse, sexual function) because of neurologic damage to this portion of the spinal nerves, and this increases the risk of their long-term morbidity.
These problems place a substantial burden on patients' physical health and quality of life (QoL).
Serious urological complications, such as urosepsis, skin breakdown, and renal failure, can occur in this patient population due to bladder dysfunction.
Approximately 50% of young adults with SB have renal dysfunction, 50% have urinary incontinence, and they are nine times more likely to present with urinary tract infections.
The "gold standard" bladder management strategy when a person with SB is unable to void spontaneously is to perform clean intermittent catheterization (CIC).
Alternatives to CIC include spontaneous voiding (if possible), incontinence products, an indwelling catheter (IDC), or reconstructive surgery (to create a urinary diversion or to enable CIC).
However, IDC and surgery have increased risks of specific complications, including the risk of bladder cancer, urethral damage, urinary infections, and surgical morbidity.
People with SB usually discuss bladder management options with their urologist, however they may prioritize a variety of factors around bladder management that directly affect their QOL, and these may not be as apparent to urologists.
This is further complicated when patients reach adolescence and young adulthood; at this age they transition from pediatric to adult care providers, all while transitioning in other areas of their life (such as increasing responsibility, cognitive growth, and a wish for more independence).
These factors may all impact thoughts about bladder management.
Few studies have addressed QoL in relation to different bladder/bowel management methods in this SB age group, and most have not considered things like health literacy and cognitive function.
Studietype
Observationeel
Inschrijving (Geschat)
300
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Mary McKibbon, BNSc
- Telefoonnummer: 519-646-6367
- E-mail: mary.mckibbon@sjhc.london.on.ca
Studie Locaties
-
-
Ontario
-
London, Ontario, Canada
- Werving
- St Joseph's Hospital
-
Contact:
- Mary McKibbon, BNSc
- Telefoonnummer: 5196466367
- E-mail: mary.mckibbon@sjhc.london.on.ca
-
Contact:
- Brenda Hodgins
- Telefoonnummer: 5196466000
- E-mail: brenda.hodgins@sjhc.london.on.ca
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
To be included in the study, participants have to be adolescents (13-17 years of age) or adults (≥18 years of age) with SB and no acute health changes.
SB included all types, including SB occulta, meningocele, lipomeningocele, and myelomeningocele.
The investigators are interested in including the SB transitional age group as well, recognizing this age group represents unique and diverse psychosocial, cognitive and functional abilities.
Beschrijving
Inclusion Criteria:
- Diagnosis of SB
- Age ≥13 years of age
- Able to effectively communicate in English or Spanish
- Willing to provide informed consent for participation and answer a set of questionnaires
Exclusion Criteria:
- Reconstructive surgery or urinary diversion in the last 3 months
- Hospital admission in the last 1 month
- Inconsistent or newly changed (within the last month) method of bladder management
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Voiding/incontinence
SB patients who manage their bladder with voiding/incontinence
|
|
CIC
SB patients who manage their bladder with clean intermittent catheters
|
|
Diversion
SB patients who manage their urination with a surgical bladder diversion
|
|
Indwelling catheter
SB patients who manage their bladder with an indwelling catheter
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
QUAlity of Life Assessment in Spina bifida (bladder and bowel quality of life domain)
Tijdsspanne: At the time of enrollment
|
The QUALAS is a validated quality of life measure for teens and adults with spina bifida.
It is scored from 0-100, with a higher score meaning better QOL
|
At the time of enrollment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Neurogenic Bladder Symptom Score-Short Form
Tijdsspanne: At time of enrollment
|
The NBSS-SF is a validated assessment of bladder symptom burden
|
At time of enrollment
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Blayne Welk, MD MSc, Western University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2025
Primaire voltooiing (Geschat)
31 oktober 2026
Studie voltooiing (Geschat)
1 november 2026
Studieregistratiedata
Eerst ingediend
4 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15140 (City of Hope Medical Center)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Beschrijving IPD-plan
The investigators will consider sharing data on a case by case basis, after the primary analysis is complete.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .