Yoga for Treatment of Overactive Bladder in Pediatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorDuke University
About this trial
The goal of this pilot study is to assess the impact of yoga as a treatment modality in pediatric patients age 8-18 diagnosed with idiopathic overactive bladder as measured by validated questionnaires and urinary biomarkers. The main question it aims to answer is: Does yoga help improve overactive bladder symptoms in this patient population? Participants will take part in a weekly yoga session for a total of 6 weeks with validated questionnaires and urinary samples for biomarkers to be completed at the beginning, middle and end of the study. This study will follow a cross-over study design and patients will receive standard of care while not in the active treatment arm.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
8-18 years of age
History of non-neurogenic overactive bladder or detrusor overactivity and/or urinary incontinence (ICD 10 codes respectively - N32.81, N39.498)
Obtained legally effective informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization from the participant or the participant's parent/legal guardian
Minor participant is willing and able to provide assent (as applicable)
Disqualifiers
Known or apparent untreated anatomical abnormality of lower urinary tract (i.e. untreated ureterocele)
Known neurogenic bladder (e.g., spina bifida, history of spinal cord injury, tethered cord)
Nerve damage that may impact pelvic floor function
History of chemodenervation of the bladder (e.g., via intravesical instillation or intradetrusor injection of botulinum toxin)
Trial design
Design model
Crossover
Treatments tested in this trial
Yoga
BehavioralRestorative Vinyasa Yoga
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: 1.1: 8-12 yoga firstExperimental treatment 1 intervention
Group B: 1.2: 13-18 yoga firstExperimental treatment 1 intervention
Group C: 2.1: 8-12 yoga secondExperimental treatment 1 intervention
Group D: 2.2: 13-18 yoga secondExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in overactive bladder symptoms
Measured via Vancouver symptom score for Dysfunctional Elimination Syndrome with modified bother score (both parts of same survey assessment to be filled out). VDES score ranging from 5-65 with higher number representing worse symptoms; modified bother score ranges from 1-4 with 1= never bothered and 4= always bothered
Time frame
0, 6 and 12 weeks2
Change in expression of nerve growth factor
nerve growth factor urinary biomarker via urine specimen collection
Time frame
0, 6 and 12 weeks3
Change in expression of interleukin - 1B
Interleukin-1B urinary biomarker via urine specimen collection
Time frame
0, 6 and 12 weeks4
Change in expression of tumor necrosis factor-alpha
tumor necrosis factor-alpha urinary biomarker via urine specimen collection
Time frame
0, 6 and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov