Yoga for Overactive Bladder

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether yoga can reduce symptoms of overactive bladder in children and teens. Participants will attend weekly yoga sessions for six weeks, complete surveys, and provide urine samples to track progress. The study compares results from the yoga sessions with usual care to determine if yoga offers additional benefits. Children and teens aged 8 to 18 who experience frequent urges to urinate or urinary incontinence without a known cause might be suitable for this trial. As an unphased trial, it offers participants the opportunity to explore a non-invasive, holistic approach to managing their symptoms.

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 prior data suggests that yoga is safe for pediatric patients with overactive bladder?

Research shows that yoga is generally safe and easy to practice. Studies have examined various age groups with urinary problems, such as urinary incontinence, and have shown promising results. For example, one study on women found that yoga significantly improved their incontinence symptoms. No major safety issues emerged, indicating that yoga is a low-risk option.

Although most research involves adults, yoga is a gentle activity and is usually safe for children and teens as well. Yoga doesn't involve medication or surgery, which typically means fewer side effects. As with any exercise, it's important to pay attention to how the body feels and consult healthcare providers if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using yoga for overactive bladder because it offers a non-drug approach to managing symptoms. Unlike the standard treatments, which often include medications like anticholinergics or beta-3 adrenergic agonists, yoga focuses on strengthening pelvic muscles and reducing stress, potentially improving bladder control without the side effects commonly associated with drugs. Additionally, yoga promotes overall well-being, which could enhance quality of life for those affected by overactive bladder. By exploring yoga as a treatment, researchers hope to find a holistic and accessible alternative that could benefit a wide range of individuals.

What evidence suggests that yoga might be an effective treatment for overactive bladder?

Research has shown that yoga might be a helpful treatment for overactive bladder. One study on mindfulness-based stress reduction found that participants experienced significant improvements in their quality of life and symptoms related to overactive bladder. Another study discovered that a group yoga program reduced the frequency of urinary incontinence (loss of bladder control) by 76% over three months. This trial will explore different yoga programs, with some participants starting yoga earlier and others later. Yoga may help manage symptoms by strengthening the pelvic floor muscles and reducing stress. While more research is needed, these early results are promising for those considering yoga as a treatment option. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 have a history of overactive bladder or urinary incontinence.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22453268/

Mindfulness-based stress reduction for treatment of urinary ... Significant improvements on both Health-Related Quality of Life and Overactive Bladder Symptom and Quality of Life-Short Form were reported after treatment.

2. auajournals.org auajournals.org/doi/10.1097/01.JU.0001110120.10144.d3.10

PD31-10 PELVIC YOGA FOR THE MANAGEMENT OF ... Pelvic floor yoga is a non-invasive, community-based therapy option for women with urinary incontinence (UI). However, efficacy data is lacking.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6314206/

A Group-Based Yoga Program for Urinary Incontinence in ... Over 3 months, total incontinence frequency decreased by an estimated 76% from baseline in the yoga group and 56% from baseline in the control group (P=.072 for ...

4. ics.org ics.org/2020/abstract/54

ICS 2020 Abstract #54 Feasibility and effectiveness of an ... The program was developed by two physical therapists with extensive training and clinical experience in physical therapy management of overactive bladder and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937818309153

A group-based yoga program for urinary incontinence in ... Over 3 months, total incontinence frequency decreased by an average of 76% from baseline in the yoga and 56% in the control group (P = .07 for between-group ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4310548/

A Group-Based Yoga Therapy Intervention for Urinary ... To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01470560

Mindfulness-Based Stress Reduction Techniques and ... Secondary Outcome Measures are a change from baseline in the Overactive Bladder Questionnaire (OABq-SF) scores and proportion of subjects ...

8. ajog.org ajog.org/article/S0002-9378(18)30915-3/fulltext

A group-based yoga program for urinary incontinence in ... Women in the yoga group also demonstrated a more than 75% average improvement in incontinence frequency over 3 months, although those assigned ...

9. escholarship.org escholarship.org/content/qt24m5j3tn/qt24m5j3tn.pdf

Efficacy of a Therapeutic Pelvic Yoga Program Versus ... This study is a randomized, investigator-blinded, superiority trial to evaluate the efficacy and safety of a group-based pelvic yoga ...