Adult Bladder and quality of Life Evaluation in Spina Bifida (ABLE-SB) Study Protocol

Background Neurogenic lower urinary tract dysfunction (NLUTD) in adults with spina bifida (SB) is an understudied problem with significant impacts on quality of life (QOL) and may lead to medically important complications including renal dysfunction, urinary infections, and incontinence. The goal of the ABLE-SB project is to investigate the QOL of an adolescent and adult SB population, with an emphasis on the impact of bladder management technique on overall QOL. Study Design This paper presents the protocol for the Adult Bladder and Quality of Life Evaluation in Spina Bifida (ABLE-SB) study, a multi-institutional (11 sites across North and South America) cross-sectional study of bladder-related patient-reported outcomes in adolescents and adults with spina bifida. Patients and Methods SB patients will be recruited from regular clinic visits with participating investigators. Inclusion criteria are SB patients ≥13 years old; exclusion criteria are recent health or bladder management changes. Estimated required sample size is calculated at 208 but has been increased to 300 to account for missing data and confounder adjustment. Demographic data will be collected by trained study coordinators, and patients will complete several patient-reported outcome measures (including the QUALAS, NBSS-SF, BRIEF health literacy assessment, and a cognitive function measure). The primary outcome is the QUALAS bladder and bowel domain, which is a validated measure of QOL in SB. The secondary outcome is bladder symptom burden, as measured by the NBSS-SF. Bladder management (primary exposure) will be grouped into 4 categories for the primary analysis: voiding/incontinent, CIC, indwelling catheter, or urinary diversion. Primary analysis will use multivariable linear regression to evaluate the association between bladder management strategy and QOL, with adjustment for prespecified demographic and clinical confounders, including age, sex, ambulatory status, cognitive function, prior urinary reconstruction, and bowel management. Study Registration: NCT07642466 (https://clinicaltrials.gov/study/NCT07642466, Registered June 4 2026). Protocol version 3.0, August 28, 2024.