- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07642466
Adult Bladder and Quality of Life Evaluation in Spina Bifida (ABLE-SB)
10. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Antatt)
300
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mary McKibbon, BNSc
- Telefonnummer: 519-646-6367
- E-post: mary.mckibbon@sjhc.london.on.ca
Studiesteder
-
-
Ontario
-
London, Ontario, Canada
- Rekruttering
- St Joseph's Hospital
-
Ta kontakt med:
- Mary McKibbon, BNSc
- Telefonnummer: 5196466367
- E-post: mary.mckibbon@sjhc.london.on.ca
-
Ta kontakt med:
- Brenda Hodgins
- Telefonnummer: 5196466000
- E-post: brenda.hodgins@sjhc.london.on.ca
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
QUAlity of Life Assessment in Spina bifida (bladder and bowel quality of life domain)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neurogenic Bladder Symptom Score-Short Form
Tidsramme: At time of enrollment
|
The NBSS-SF is a validated assessment of bladder symptom burden
|
At time of enrollment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Blayne Welk, MD MSc, Western University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2025
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
1. november 2026
Datoer for studieregistrering
Først innsendt
4. juni 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15140 (City of Hope Medical Center)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
The investigators will consider sharing data on a case by case basis, after the primary analysis is complete.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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