Yoga for Treatment of Overactive Bladder in Pediatric Patients

NCT05895045 | Recruiting

• 1 other identifier: Pro00112833
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Overactive Bladder Syndrome; Overactive Detrusor

Keywords

bladder; overactive; detrusor; pediatric

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

1.1: 8-12 yoga first

EXPERIMENTAL

Behavioral: Yoga

1.2: 13-18 yoga first

EXPERIMENTAL

Behavioral: Yoga

2.1: 8-12 yoga second

EXPERIMENTAL

Behavioral: Yoga

2.2: 13-18 yoga second

EXPERIMENTAL

Behavioral: Yoga

Interventions

Yoga BEHAVIORAL

Restorative Vinyasa Yoga

1.1: 8-12 yoga first; 1.2: 13-18 yoga first; 2.1: 8-12 yoga second; 2.2: 13-18 yoga second

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27701, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Yoga

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Rafael Tua-Caraccia, MD

CONTACT

7865546150; rdt25@duke.edu

Jonathan Routh, MD, MPH

CONTACT

(919) 684-6994; jonathan.routh@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)