This is an interventional study examining the effects of closed diurnal indwelling catheterization (CDIC) for neurogenic bladder management.
This is an interventional study examining the effects of indwelling diurnal catheter use in 10 to 21 year old individuals with neurogenic bladder due to Spina Bifida or spinal cord injury.Subject participation is expected to last up to 6 months.Eligible, interested patients will complete a pre-study visit for a clinical assessment by a pediatric urologist, informed consent completion and education regarding the diurnal use of indwelling foley catheters. Each patient will be screened to ensure that they have completed standard studies of urologic function within the last six months including a serum chemistry panel, renal ultrasound, KUB, and urodynamic studies. Within four weeks prior to study onset, a UA and culture, pad weighing test and voiding diary will be completed. After initiation of diurnal catheter use, weekly screening calls and adverse event screening will be completed by the study coordinator with involvement of a pediatric urologist for evaluation and management as required for all screens with responses concerning for either symptomatic urinary tract infection or adverse event. There will be clinical assessments at SHCNC by the nurse practitioner or pediatric urologist at Week 4, 12 and 24 of participation (adverse event assessment, quality of life questionnaire completion, pad weight tests, voiding diary completion and UA/ culture). At the Week 12 and 24 visits, a renal ultrasound will be completed. The option that the investigators propose is novel and is the use of an indwelling urethral catheter placed in the morning, remaining in place for 8 hours ('diurnal' indwelling catheter). Bladder drainage will occur on a scheduled basis during the school day or workday by the simple opening of the closed catheter. After eight hours, each evening, the indwelling catheter will be removed with resumption of CIC. This would be a convenient and practical solution that could simultaneously avoid many of the risks associated with long-term indwelling urethral catheter use, while still allowing for the improved independence, convenience and privacy desired by youth with spina bifida or spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
Each participant underwent an evaluation during standard of care CIC use vs evaluations during use of the study intervention (CDIC).
Medical Outcomes Trust SF-36
Quality of Life is measured by questionnaire Medical Outcomes Trust SF-36. The physical component and mental component summary measures were selected from the SF-36 questionnaire. It measures change from baseline on CIC to week 4 of CDIC use in health related quality of life. We obtained the SF-36 site license from Quality Metric (Lincoln, RI) and are utilizing the proprietary software for all composite analyses.
Time frame: at baseline, week 4,12, and 24
Urinary continence
Urinary specific quality of life will be assessed by the validated King's Health Questionnaire (KHQ). The King's Health Questionnaire (KHQ) consists of two portions, 21 questions total, which address general health and the impact of incontinence including limitations to roles, physical, emotional, social and personal domains, sleep disturbance and incontinence severity. Differences in component summary scores will be assessed at each endpoint weeks 4, 12, and 24 and compared to baseline scores as noted for the SF-36.
Time frame: at baseline, week 4,12, and 24
PedsQL
Pediatric quality of life will be assessed by the PedsQL (pediatric quality of life) 4.0 Generic Core Scales includes scales that assess child self-report and parent proxy-report of generic core health outcomes from the physical, emotional, social and school domains. Outcome endpoints and analyses are as described for the SF-36 and KHQ above and will evaluate each summary domain score at 4, 12 and 24 weeks on trial in comparison to baseline evaluation.
Time frame: at baseline, week 4,12, and 24
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