Yoga for Overactive Bladder
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Neurogenic bladder, Nerve damage, Pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
13567How 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.
89101112Eligibility 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.
+2 more
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.
+4 more
Trial 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)
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: 2.2: 13-18 yoga secondExperimental Treatment1 Intervention
Group II: 2.1: 8-12 yoga secondExperimental Treatment1 Intervention
Group III: 1.2: 13-18 yoga firstExperimental Treatment1 Intervention
Group IV: 1.1: 8-12 yoga firstExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University HospitalDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
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]The objective of this study is to compare the effects of mindfulness-based stress reduction (MBSR) versus yoga on urinary urge incontinence (UI) at 8 weeks, 6 months, and 1 year after beginning an 8-week program.
Drug therapy for overactive bladder. [2017]Overactive bladder is a syndrome with a significant worldwide prevalence and economic impact on health resources. With ageing populations, the health burden of this condition that is more common in older people, is likely to increase. Following conservative therapies, medical management of overactive bladder is the mainstay of treatment, usually with antimuscarinic therapy. However, adherence is poor either due to adverse events or lack of efficacy of therapy. There have been recent developments that include a β3-adrenoreceptor agonist and intradetrusor botulinum toxin, both of which are increasingly supported by a robust evidence base. Additionally there are emerging combination therapies and novel target agents that aim to treat this troubling syndrome. Alternative modes of delivery for existing therapies are also being explored with a view to improving adherence and efficacy. This article aims to outline the evidence base for existing and novel therapies as well as inform readers of emerging therapeutic options.
Yoga's Biophysiological Effects on Lower Urinary Tract Symptoms: A Scoping Review. [2019]Yoga is a mind and body practice that includes relaxation, meditation, breathing exercises, and body postures. It can be effective in enhancing the functioning of several body systems, including the lower urinary tract. Normal lower urinary tract functioning depends in part on the coordination of the bladder, urethra, pelvic floor and other muscles, and the nerves that control them. Lower urinary tract dysfunction can lead to symptoms, that is, stress urinary incontinence (UI), urinary frequency, nocturia, urinary urgency with and without incontinence, and mixed UI. Recent evidence suggests that yoga can improve lower urinary tract symptoms (LUTS). Thus, we performed a scoping review of the literature with regard to the evidence for the effects of yoga on LUTS and factors that may mediate yoga's effects on LUTS with the goal to identify gaps in knowledge regarding the relationship between yoga practice and LUTS.
Contemporary management of overactive bladder. [2012]Overactive bladder is a prevalent condition with bothersome symptoms that greatly impact health-related quality of life. Despite a multitude of treatment options, many patients go untreated or undertreated. This article addresses the contemporary management of overactive bladder, including behavioral and lifestyle modifications, pelvic floor muscle therapy, biofeedback, drug therapy, neuromodulation, and botulinum toxin. We highlight the new drugs and therapies that have been brought into clinical use over the past few years, and discuss important clinical implications of therapy as well as promising new agents that are currently in advanced stages of development.
Integrating yoga therapy in the management of urinary incontinence: a case report. [2022]A 63-year-old overweight female prediagnosed of stress urinary incontinence presented with exacerbated events of urine leakage. She was advised a residential lifestyle and behavioral program, primarily consisting of a monitored yoga therapy module, apart from her ongoing anticholinergic medicine, for 21 days. Assessments were based on a frequency volume chart, a bladder diary for the entire duration of treatment, and the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form questionnaire on the days of admission and discharge. A total of 1.9 kg of weight loss was observed during her stay. Usage of pad, as reported in her diary, reduced from 3 to 1 per day. Her International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form score reduced from 16 to 9, indicating better continence. She expressed subjective well-being and confidence in her social interactions. This is probably the first case report demonstrating feasibility of integration of yoga therapy in the management of urinary incontinence.
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P
App-Based Yoga of Immortals: A Novel, Easy-to-use Intervention in the Management of Urinary Incontinence. [2022]To study the effectiveness Yoga of Immortals (YOI) intervention in participants with urinary incontinence (UI) of all types. YOI uniquely combines specific yogic postures, breathing exercises, sound therapy & meditation and is practiced by many for general well-being.
Treatment of essential hypertension with yoga relaxation therapy in a USAF aviator: a case report. [2008]A 46-year-old Caucasian male USAF aviator with a 6-year history of mild essential hypertension (medical waiver for flight duty) under unsuccessful treatment with hydrochlorothiazide, dietary modification, and exercise, was subsequently trained in yoga relaxation. After 6 weeks, medication had been discontinued, and his diastolic blood pressure remained within normal levels. The patient was subsequently returned to full flight status without recurrence of diastolic hypertension at followup 6 months later. Relaxation training, of which yoga is one type, has been reported in the medical literature to have wide clinical application. It should be considered as a nonpharmacological therapy adjunct or alternative for medical disorders among personnel in occupations (e.g., aviation) where the side effects from medications are of great concern and could be disqualifying from those duties.
Guidelines for developing yoga interventions for randomized trials. [2022]Little guidance is available to assist researchers in developing treatment protocols for research on yoga for health concerns. Because yoga is a complex multifactorial mind-body discipline historically developed for nonmedical purposes, numerous decisions must be made in order to thoughtfully develop such protocols. In this paper, a systematic approach is proposed to assist researchers in selecting an intervention that is appropriate for the condition under consideration and explicitly developed. Researchers need to consider the type or "style" of yoga, the components to include (e.g., breathing exercises, postures) as well as the specific protocol for each component, the dose to be delivered (frequency, duration of practice, and the total duration of practice), and issues related to selection of instructors and monitoring the fidelity to the intervention. Each of these domains and the key issues for the development of protocols is discussed. Finally, some areas for further research related to protocol development are recommended.
Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. [2021]Rates of mental health illnesses and burnout are increasing internationally. Therapeutic yoga is increasingly used to improve and maintain physical, mental and emotional well-being and general health. This protocol describes a study to evaluate the effectiveness of an existing primary care group-based therapeutic yoga programme, the Yoga of Stress Resilience programme, which combines yoga and psychotherapeutic techniques, in improving mental health and decreasing burnout. Implementation factors will also be evaluated for potential scale-up.
Best Practices for Adapting and Delivering Community-Based Yoga for People with Traumatic Brain Injury in the United States and Canada. [2020]Emerging benefits of yoga for traumatic brain injury (TBI) suggest that broader accessibility to community-based yoga programming is important. This cross-sectional, mixed methods study sought to identify best practices for adapting and delivering community-based yoga to people with TBI. An online survey was sent to 175 yoga teachers trained to teach LoveYourBrain Yoga, a community-based, 6-week, manualized program for people with TBI and their care-givers. The survey instrument included open- and closed-text questions assessing teachers' perspectives on the most and least helpful adaptions for asana, meditation, pranayama, and group discussion, and on the LoveYourBrain Yoga training and support. Responses we re analyzed using d e s c r i p t i ve statistics and qualitative content analysis. Eighty-six teachers (50%) responded. Best practices for adapting yoga for TBI revealed six themes: (1) simple, slow, and repeated; (2) creating a safe space; (3) position of the head and neck; (4) demonstration; (5) importance of props; and (6) special considerations for yoga studios. Three themes emerged for yoga program delivery: (1) structured yet flexible; (2) acceptability of compensation; and (3) time management. Eighty-nine percent of teachers reported that the program manual was very/extremely helpful, yet nearly half (49%) adapted the manual content often/always. To deliver community-based yoga services for TBI, we recommend an environment with props, low light and noise, and sufficient space, along with the facilitation of consistent instruction with a manual that allows for flexibility. We recommend that yoga teachers have skills in physical modifications for the head and neck; slow, simple, and repeated cueing to facilitate cognitive processing; managing challenging behaviors through redirection techniques; and promoting safety through inclusivity, compassion, and personal agency.
Yoga for rehabilitation: an overview. [2022]The use of yoga for rehabilitation has diverse applications. Yoga practice benefited mentally handicapped subjects by improving their mental ability, also the motor co-ordination and social skills. Physically handicapped subjects had a restoration of some degree of functional ability after practicing yoga. Visually impaired children children showed a significant decrease in their abnormal anxiety levels when they practiced yoga for three weeks, while a program of physical activity had no such effect. Socially disadvantaged adults (prisoners in a jail) and children in a remand home showed significant improvement in sleep, appetite and general well being, as well as a decrease in physiological arousal. The practice of meditation was reported to decrease the degree of substance (marijuana) abuse, by strengthening the mental resolve and decreasing the anxiety. Another important area is the application of yoga (and indeed, lifestyle change), in the rehabilitation of patients with coronary artery disease. Finally, the possible role of yoga in improving the mental state and general well being of HIV positive persons and patients with AIDS, is being explored.