Yoga for Treatment of Overactive Bladder in Pediatric Patients

• Sponsor: Duke University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05895045
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 9.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Overactive Bladder Syndrome; Overactive Detrusor	Behavioral: Yoga	N/A

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 we hypothesize that yoga will lead to improved quality of life, reduced urinary symptoms and reduced expression of inflammatory urinary biomarkers.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: We 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.We 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: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Yoga for Treatment of Overactive Bladder in Pediatric Patients
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in overactive bladder symptoms [0, 6 and 12 weeks]

   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

2. Change in expression of nerve growth factor [0, 6 and 12 weeks]

   nerve growth factor urinary biomarker via urine specimen collection

3. Change in expression of interleukin - 1B [0, 6 and 12 weeks]

   Interleukin-1B urinary biomarker via urine specimen collection

4. Change in expression of tumor necrosis factor-alpha [0, 6 and 12 weeks]

   tumor necrosis factor-alpha urinary biomarker via urine specimen collection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27701

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05895045
• Other Study ID Numbers: Pro00112833
• First Posted: Jun 8, 2023
• Last Update Posted: Jun 8, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: bladder; overactive; detrusor; pediatric
• Additional relevant MeSH terms: Urinary Bladder, Overactive

Study Results

No Results Posted as of Jun 8, 2023