An observational study in Spina Bifida or Spinal Dysraphism, sponsored by Blayne Welk. Recruiting at 1 site in Canada. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Blayne Welk · Observational
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.
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 300 is above the median of 105 across 48 observational studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →This is the only study on the registry with Blayne Welk as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SB patients who manage their bladder with voiding/incontinence
SB patients who manage their bladder with clean intermittent catheters
SB patients who manage their urination with a surgical bladder diversion
SB patients who manage their bladder with an indwelling catheter
QUAlity of Life Assessment in Spina bifida (bladder and bowel quality of life domain)
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
Time frame: At the time of enrollment
Neurogenic Bladder Symptom Score-Short Form
The NBSS-SF is a validated assessment of bladder symptom burden
Time frame: At time of enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The investigators will consider sharing data on a case by case basis, after the primary analysis is complete.
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