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Yoga for Treatment of Overactive Bladder in Pediatric Patients

Primary Purpose

Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring bladder, overactive, detrusor, pediatric

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Vancouver Dysfunctional Elimination Syndrome[15] score of ≥11 and a positive modified bother score within 30 days of consent Exclusion Criteria: 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) Active, untreated UTI at the time of enrollment (UTI undergoing active treatment is allowable) Current or previous pregnancy at screening or planned pregnancy during the duration of the study, for females of childbearing potential Any condition that, in the judgment of the investigator or treating clinician, precludes participation because it could affect participant safety

Sites / Locations

  • Duke University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1.1: 8-12 yoga first

1.2: 13-18 yoga first

2.1: 8-12 yoga second

2.2: 13-18 yoga second

Arm Description

Outcomes

Primary Outcome Measures

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
Change in expression of nerve growth factor
nerve growth factor urinary biomarker via urine specimen collection
Change in expression of interleukin - 1B
Interleukin-1B urinary biomarker via urine specimen collection
Change in expression of tumor necrosis factor-alpha
tumor necrosis factor-alpha urinary biomarker via urine specimen collection

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
September 12, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05895045
Brief Title
Yoga for Treatment of Overactive Bladder in Pediatric Patients
Official Title
Yoga for Treatment of Overactive Bladder in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Detrusor overactivity, otherwise known as overactive bladder (OAB) is the most common disease of voiding dysfunction in children and is characterized by urgency with or without incontinence. Current understanding of OAB suggests that it is a component of central sensitization whereby the central nervous system is in a persistent state of high reactivity. In this state, patients have lower thresholds for pain and for normal physiologic signals such as the sensation of bladder fullness. Yoga has been shown to favor parasympathetic output and appears to be effective in reversing central sensitization for patients with chronic pain. Further, both central sensitization and OAB have been associated with inflammation and so observation of urinary markers of inflammation allow an objective measurement, along with subjective symptom reporting, to measure treatment effects. Children with OAB are likely to become adults with similar urinary complaints and are also more likely to have anxiety, depression and other problems throughout development and maturation. Treatment for OAB in children is comprised of first conservative management with behavioral therapies including biofeedback, subsequent addition of pharmacologic treatment options and finally more invasive therapies including intradetrusor botulinum toxin injections and neuromodulation. Yoga has been shown to have some positive health benefits in pediatric patients with pulmonary dysfunction, epilepsy, anxiety/depression and even in pediatric oncology patients with regards to quality of life during treatment. Additionally, yoga has been assessed as an adjunctive therapy for the treatment of urinary incontinence and overactive bladder in predominantly adult female populations. That said, to date there have been no studies assessing the impact of yoga on detrusor overactivity in pediatric patient populations (< 19 years old). This is a pilot study in which the investigators hypothesize that yoga will lead to improved quality of life, reduced urinary symptoms and reduced expression of inflammatory urinary biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
Keywords
bladder, overactive, detrusor, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study will start with two treatment arms. Arm 1 will receive standard behavioral modification and possible pharmacologic intervention for six weeks without other intervention. Arm 2 will receive the same therapies in addition to participating in a weekly yoga session for six weeks. At six weeks, arms 1 and 2 we will switch intervention - Arm 1 will then initiate a weekly yoga session for six weeks with emphasis on the pelvic floor relaxation while Arm 2 will continue with standard behavioral / pharmacologic therapy. Patients will be divided into two separate yoga groups based on age. The first group will be comprised of 8-12-year-old and the second group will be comprised of 13 - 18-year-old. These will be divided within each treatment arm (i.e Arm 1.1 and 1.2) and the interventions will remain the same.
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.1: 8-12 yoga first
Arm Type
Experimental
Arm Title
1.2: 13-18 yoga first
Arm Type
Experimental
Arm Title
2.1: 8-12 yoga second
Arm Type
Experimental
Arm Title
2.2: 13-18 yoga second
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Restorative Vinyasa Yoga
Primary Outcome Measure Information:
Title
Change in overactive bladder symptoms
Description
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 weeks
Title
Change in expression of nerve growth factor
Description
nerve growth factor urinary biomarker via urine specimen collection
Time Frame
0, 6 and 12 weeks
Title
Change in expression of interleukin - 1B
Description
Interleukin-1B urinary biomarker via urine specimen collection
Time Frame
0, 6 and 12 weeks
Title
Change in expression of tumor necrosis factor-alpha
Description
tumor necrosis factor-alpha urinary biomarker via urine specimen collection
Time Frame
0, 6 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Vancouver Dysfunctional Elimination Syndrome[15] score of ≥11 and a positive modified bother score within 30 days of consent Exclusion Criteria: 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) Active, untreated UTI at the time of enrollment (UTI undergoing active treatment is allowable) Current or previous pregnancy at screening or planned pregnancy during the duration of the study, for females of childbearing potential Any condition that, in the judgment of the investigator or treating clinician, precludes participation because it could affect participant safety
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Tua-Caraccia, MD
Phone
7865546150
Email
rdt25@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Routh, MD, MPH
Phone
(919) 684-6994
Email
jonathan.routh@duke.edu
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Routh, MD, MPH
Phone
919-684-6994
Email
jonathan.routh@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Yoga for Treatment of Overactive Bladder in Pediatric Patients

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