Yoga for Overactive Bladder

Recruiting in Durham (>99 mi)

Overseen By Jonathan Routh, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Neurogenic bladder, Nerve damage, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications. It seems that participants will continue their standard care while not in the active treatment arm.

What data supports the effectiveness of yoga and mindfulness programs as a treatment for overactive bladder?

Research suggests that yoga and mindfulness programs can help improve symptoms of urinary incontinence and lower urinary tract issues, which are related to overactive bladder. A study comparing mindfulness-based stress reduction and yoga found improvements in urinary urge incontinence, and a review indicated that yoga can enhance the functioning of the lower urinary tract. ^{1 2 3 4 5}

Is yoga generally safe for humans?

A review of 94 studies involving 8,430 participants found no significant differences in serious or nonserious adverse events between yoga and usual care or exercise, suggesting that yoga is generally safe for humans. ^{1 3 5 6 7}

How does yoga treatment for overactive bladder differ from other treatments?

Yoga for overactive bladder is unique because it combines physical postures, breathing exercises, and meditation to improve mental and physical well-being, unlike standard medical treatments that often involve medication or surgery. This mind-body approach can enhance relaxation and stress resilience, potentially reducing bladder symptoms without the side effects associated with drugs. ^{8 9 10 11 12}

Eligibility Criteria

This trial is for children and teenagers aged 8-18 with idiopathic overactive bladder, who have a specific score indicating the condition's severity. They must be able to give consent or have it provided by a guardian. Those with untreated urinary tract abnormalities, neurogenic bladder conditions, nerve damage affecting pelvic function, or recent toxin treatments for the bladder are excluded.

Inclusion Criteria

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)

I am between 8 and 18 years old.

Exclusion Criteria

Any condition that, in the judgment of the investigator or treating clinician, precludes participation because it could affect participant safety

I have an untreated abnormality in my lower urinary tract.

I have nerve damage that affects my pelvic floor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in a weekly yoga session for a total of 6 weeks, with validated questionnaires and urinary samples for biomarkers completed at the beginning, middle, and end of the study

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in overactive bladder symptoms and urinary biomarkers

6 weeks

2 visits (in-person)

Treatment Details

Interventions

• Yoga

Trial Overview The study tests if yoga can improve symptoms of overactive bladder in young patients through weekly sessions over six weeks. It uses questionnaires and urine tests to measure changes. The cross-over design means all participants receive both standard care and the yoga intervention at different times during the study.

Participant Groups

Group I: 2.2: 13-18 yoga second Experimental Treatment 1 Intervention

Group II: 2.1: 8-12 yoga second Experimental Treatment 1 Intervention

Group III: 1.2: 13-18 yoga first Experimental Treatment 1 Intervention

Group IV: 1.1: 8-12 yoga first Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Mindfulness-based stress reduction (MBSR) significantly reduced urinary urge incontinence episodes compared to yoga, with a median percent change of -55.6% at 8 weeks, -71.4% at 6 months, and -66.7% at 1 year, indicating its potential efficacy as a treatment.

Participants in the MBSR group reported greater improvements in quality of life related to overactive bladder symptoms compared to the yoga group, particularly at the 8-week mark, suggesting that MBSR may offer additional benefits beyond just reducing incontinence episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mindfulness-based stress reduction versus yoga on urinary urge incontinence: a randomized pilot study. with 6-month and 1-year follow-up visits. Baker, J., Costa, D., Guarino, JM., et al.[2015]

Overactive bladder is a common condition, especially in older adults, and current treatments often face challenges with patient adherence due to side effects or lack of effectiveness.

Recent advancements in treatment options, such as β3-adrenoreceptor agonists and intradetrusor botulinum toxin, show promise and are supported by strong evidence, along with ongoing research into combination therapies and new delivery methods to enhance treatment adherence and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug therapy for overactive bladder. Izett, M., Zacchè, M., Giarenis, I., et al.[2017]

A scoping review of 8 studies suggests that yoga can potentially reduce lower urinary tract symptoms (LUTS) by strengthening pelvic floor muscles and regulating the autonomic nervous system.

Yoga is a noninvasive approach that may improve LUTS, but more rigorous research is needed to fully understand the specific mechanisms behind its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga's Biophysiological Effects on Lower Urinary Tract Symptoms: A Scoping Review. Sha, K., Palmer, MH., Yeo, S.[2019]

Overactive bladder significantly affects quality of life, yet many patients remain untreated or inadequately treated despite various available therapies.

Recent advancements in treatment options, including new drugs and therapies, offer promising alternatives for managing overactive bladder, emphasizing the importance of comprehensive management strategies that include behavioral modifications and innovative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary management of overactive bladder. Smith, AL., Wein, AJ.[2012]

A 63-year-old woman with stress urinary incontinence showed significant improvement after a 21-day program that included monitored yoga therapy, resulting in a reduction of daily pad usage from 3 to 1.

The patient's urinary incontinence questionnaire score improved from 16 to 9, indicating better continence and increased subjective well-being, suggesting that yoga therapy can be a feasible complementary treatment for urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating yoga therapy in the management of urinary incontinence: a case report. Vinchurkar, SA., Arankalle, DV.[2022]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

The Yoga of Immortals (YOI) intervention significantly reduced urinary incontinence symptoms and improved quality of life in 258 participants over 8 weeks, as measured by standardized questionnaires.

Participants reported feeling 'very much better' after the intervention, highlighting the effectiveness of this app-based program that allows for flexible practice anywhere and anytime.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Yoga of Immortals: A Novel, Easy-to-use Intervention in the Management of Urinary Incontinence. Tunuguntla, HSGR., Tunuguntla, R., Kathuria, H., et al.[2022]

A 46-year-old male aviator with a history of mild hypertension successfully managed his blood pressure through yoga relaxation training, allowing him to discontinue medication after 6 weeks.

This case suggests that yoga can be an effective nonpharmacological treatment for hypertension, particularly in occupations like aviation where medication side effects may pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of essential hypertension with yoga relaxation therapy in a USAF aviator: a case report. Brownstein, AH., Dembert, ML.[2008]

The paper provides a systematic approach for researchers to develop effective yoga treatment protocols for health concerns, emphasizing the need to carefully select the style of yoga, components, and specific protocols tailored to the condition being studied.

Key considerations include determining the frequency and duration of practice, instructor selection, and ensuring fidelity to the intervention, which are crucial for the efficacy of yoga as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for developing yoga interventions for randomized trials. Sherman, KJ.[2022]

The study will evaluate the effectiveness of the Yoga of Stress Resilience program, which combines yoga and psychotherapy, in improving mental health and reducing burnout among adults experiencing anxiety and burnout.

Using a before-after interventional trial design, the study will assess various mental health outcomes, including anxiety, depression, and functional impairment, to determine the program's impact over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. Alvarez, E., Sutton, A., Barton, B., et al.[2021]

A study involving 86 yoga teachers identified best practices for adapting community-based yoga for individuals with traumatic brain injury (TBI), emphasizing the importance of creating a safe and supportive environment with props and low sensory stimulation.

Teachers found the LoveYourBrain Yoga program manual very helpful, but many adapted its content to better meet the needs of TBI participants, highlighting the need for flexibility in instruction and the importance of slow, simple, and repeated cues for effective learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for Adapting and Delivering Community-Based Yoga for People with Traumatic Brain Injury in the United States and Canada. Chauhan, N., Zeller, S., Donnelly, KZ.[2020]

Yoga practice has shown significant benefits for various populations, including mentally handicapped individuals who improved in mental ability and social skills, and physically handicapped individuals who regained some functional abilities.

In specific studies, visually impaired children experienced reduced anxiety after three weeks of yoga, while socially disadvantaged adults and children reported improvements in sleep, appetite, and overall well-being, highlighting yoga's potential in rehabilitation across diverse groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for rehabilitation: an overview. Telles, S., Naveen, KV.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of mindfulness-based stress reduction versus yoga on urinary urge incontinence: a randomized pilot study. with 6-month and 1-year follow-up visits. [2015]

2. Italy pubmed.ncbi.nlm.nih.gov

Drug therapy for overactive bladder. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Yoga's Biophysiological Effects on Lower Urinary Tract Symptoms: A Scoping Review. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Contemporary management of overactive bladder. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Integrating yoga therapy in the management of urinary incontinence: a case report. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

App-Based Yoga of Immortals: A Novel, Easy-to-use Intervention in the Management of Urinary Incontinence. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of essential hypertension with yoga relaxation therapy in a USAF aviator: a case report. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Guidelines for developing yoga interventions for randomized trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Best Practices for Adapting and Delivering Community-Based Yoga for People with Traumatic Brain Injury in the United States and Canada. [2020]

12. India pubmed.ncbi.nlm.nih.gov

Yoga for rehabilitation: an overview. [2022]