Neurogenic Bladder Clinical Trial
Official title:
Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life for Patients With Spina Bifida and Spinal Cord Injury
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.
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