Yoga for Treatment of Overactive Bladder in Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Overactive Detrusor; Overactive Bladder Syndrome
• Intervention / Treatment: Behavioral: Yoga

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael Tua-Caraccia, MD; Phone Number: 7865546150; Email: rdt25@duke.edu
• Study Contact Backup: Name: Jonathan Routh, MD, MPH; Phone Number: (919) 684-6994; Email: jonathan.routh@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Recruiting
      • Duke University Hospital
      • Contact: Jonathan Routh, MD, MPH; Phone Number: 919-684-6994; Email: jonathan.routh@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.1: 8-12 yoga first	Behavioral: Yoga; Restorative Vinyasa Yoga
Experimental: 1.2: 13-18 yoga first	Behavioral: Yoga; Restorative Vinyasa Yoga
Experimental: 2.1: 8-12 yoga second	Behavioral: Yoga; Restorative Vinyasa Yoga
Experimental: 2.2: 13-18 yoga second	Behavioral: Yoga; Restorative Vinyasa Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0, 6 and 12 weeks
Change in expression of nerve growth factor	nerve growth factor urinary biomarker via urine specimen collection	0, 6 and 12 weeks
Change in expression of interleukin - 1B	Interleukin-1B urinary biomarker via urine specimen collection	0, 6 and 12 weeks
Change in expression of tumor necrosis factor-alpha	tumor necrosis factor-alpha urinary biomarker via urine specimen collection	0, 6 and 12 weeks

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; bladder; overactive; detrusor
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: Pro00112833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No