Bowel and Bladder Continence Among Children with Spina Bifida
January 31, 2005
Principle Investigator: Eric B. Levey, MD
AUCD Institution: The Kennedy Krieger Research Institute
AUCD RTOI #: 2005-5/6-01
Abstract
Background: Spina bifida (SB) remains a common birth
defect in the United States, affecting approximately one in three
thousand live births. Even with medical and surgical advances made
in the treatment of SB over the past 3 decades, management of neurogenic
bladder and bowel remains a major challenge. A significant proportion
of individuals with SB fail to ever achieve bladder and bowel continence.
Specific Aims
The overall goal of this research project is to systematically
define and describe the physiological, behavioral and environmental
variables that moderate interdisciplinary clinical practices for
management of neurogenic bladder and bowel in children with SB.
Design
Both retrospective clinical data and prospective experimental
data will be obtained and analyzed to address study aims. A retrospective
chart review study will be done on about 100 individuals who were
seen through the Kennedy Krieger Institute Spina Bifida Center in
the past 3 years. The prospective study will utilize a two group
experimental design with study participants randomized to an intervention
group and a control group, with plans to enroll 30 subjects per
group. The intervention group will receive Usual Care + Behavioral
Intervention Protocol and the control group will receive Usual Care.
Study Population
Study subjects will be individuals with spina
bifida ages 5 to 18 years old. Subjects will be recruited through
the KKI Spina Bifida Center, Johns Hopkins Pediatric Urology Clinic
and from the surrounding area through the Chesapeake-Potomac Spina
Bifida Association.
Behavioral Intervention
The intervention group will participate
in an 8-week behavioral intervention. A tool assessing barriers
to medical adherence will be developed using our experience and
findings of the retrospective study. Each subject in the intervention
group will have an individualized assessment and development of
a behavioral plan. Intervention will include antecedent management
(a written daily schedule), pager prompting for medication and CIC,
a behavioral incentive (positive reinforcement) program, coping
skills training, and behavioral support therapy in clinic and by
phone.
Measurement
Measures will include a standard interview about medical
and surgical history, current medical regiment and barriers to adherence.
Baseline results of creatinine, BUN, GFR, kidney and bladder ultrasounds,
and VCUG will be documented. Urodyanamic studies will be done at
study entry and at one year. Measurement tools will include ratings
of bladder and bowel continence, health-related quality of life,
medical adherence, self-perception, and social support.