Overactive BladderNCT05895045
Yoga for Treatment of Overactive Bladder in Pediatric Patients
A study testing Yoga in people with Overactive Bladder and Overactive Bladder Syndrome, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27701
About this study
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.
Read the 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.
- Being tested
- Yoga
- Keywords
- bladder, overactive, detrusor, pediatric
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Restorative Vinyasa Yoga
| Study group | Role | What they receive |
|---|---|---|
| 1.1: 8-12 yoga first | Experimental | Not described Receives: Behavioral: Yoga |
| 1.2: 13-18 yoga first | Experimental | Not described Receives: Behavioral: Yoga |
| 2.1: 8-12 yoga second | Experimental | Not described Receives: Behavioral: Yoga |
| 2.2: 13-18 yoga second | Experimental | Not described Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 6 and 12 weeks
Change in expression of nerve growth factor
nerve growth factor urinary biomarker via urine specimen collection
Measured: 0, 6 and 12 weeks
Change in expression of interleukin - 1B
Interleukin-1B urinary biomarker via urine specimen collection
Measured: 0, 6 and 12 weeks
Change in expression of tumor necrosis factor-alpha
tumor necrosis factor-alpha urinary biomarker via urine specimen collection
Measured: 0, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start12 Oct 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Why it stopped: Lack of adequate accrual - single enrolled patient was immediately lost to follow-up despite many, many attempts at re-engagement and vigorous clinical recruiting of other potential participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895045
- Sponsor's protocol ID
- Pro00112833
- Status last verified
- Jul 2026
- First submitted
- 30 May 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Treatment of Overactive Bladder in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05895045
- Acronym / sponsor ID
- Pro00112833
- Keywords
- bladder, overactive, detrusor, pediatric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of adequate accrual - single enrolled patient was immediately lost to follow-up despite many, many attempts at re-engagement and vigorous clinical recruiting of other potential participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaRestorative Vinyasa Yoga | Behavioural | 1.1: 8-12 yoga first, 1.2: 13-18 yoga first, 2.1: 8-12 yoga second, 2.2: 13-18 yoga second |
Primary outcome
Change in overactive bladder symptoms
Time frame: 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
Change in expression of nerve growth factor
Time frame: 0, 6 and 12 weeks
nerve growth factor urinary biomarker via urine specimen collection
Change in expression of interleukin - 1B
Time frame: 0, 6 and 12 weeks
Interleukin-1B urinary biomarker via urine specimen collection
Change in expression of tumor necrosis factor-alpha
Time frame: 0, 6 and 12 weeks
tumor necrosis factor-alpha urinary biomarker via urine specimen collection
Results and safety
The study was stopped early (reason given: Lack of adequate accrual - single enrolled patient was immediately lost to follow-up despite many, many attempts at re-engagement and vigorous clinical recruiting of other potential participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Overactive Bladder and Overactive Bladder Syndrome, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of adequate accrual - single enrolled patient was immediately lost to follow-up despite many, many attempts at re-engagement and vigorous clinical recruiting of other potential participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overactive bladder symptoms (time frame: 0, 6 and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.