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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 6 and 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if yoga helps children with overactive bladder. Patients will do yoga for 6 weeks and have questionnaires/urine tests to measure results.
Who is the study for?
This trial is for children and teenagers aged 8-18 with idiopathic overactive bladder, who have a specific score indicating the condition's severity. They must be able to give consent or have it provided by a guardian. Those with untreated urinary tract abnormalities, neurogenic bladder conditions, nerve damage affecting pelvic function, or recent toxin treatments for the bladder are excluded.
What is being tested?
The study tests if yoga can improve symptoms of overactive bladder in young patients through weekly sessions over six weeks. It uses questionnaires and urine tests to measure changes. The cross-over design means all participants receive both standard care and the yoga intervention at different times during the study.
What are the potential side effects?
Since this trial involves yoga as an intervention, side effects might include muscle soreness or strain from physical postures. However, serious side effects are unlikely given the nature of yoga as a gentle exercise practice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 18 years old.
Select...
I have a history of overactive bladder or urinary incontinence.
Select...
I have a high score for bladder problems and it bothers me.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an untreated abnormality in my lower urinary tract.
Select...
I have a bladder condition due to nerve problems.
Select...
I have had bladder treatments with Botox.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 6 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 6 and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in expression of interleukin - 1B
Change in expression of nerve growth factor
Change in expression of tumor necrosis factor-alpha
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: 2.2: 13-18 yoga secondExperimental Treatment1 Intervention
Group II: 2.1: 8-12 yoga secondExperimental Treatment1 Intervention
Group III: 1.2: 13-18 yoga firstExperimental Treatment1 Intervention
Group IV: 1.1: 8-12 yoga firstExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yoga
2008
Completed Phase 3
~3830
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,512 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an untreated abnormality in my lower urinary tract.I have nerve damage that affects my pelvic floor.I have a bladder condition due to nerve problems.I have had bladder treatments with Botox.I do not have an active, untreated urinary tract infection.I am between 8 and 18 years old.I have a history of overactive bladder or urinary incontinence.I have a high score for bladder problems and it bothers me.
Research Study Groups:
This trial has the following groups:- Group 1: 1.1: 8-12 yoga first
- Group 2: 1.2: 13-18 yoga first
- Group 3: 2.1: 8-12 yoga second
- Group 4: 2.2: 13-18 yoga second
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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