Brain-Centered Therapy versus Medication for Urgency Urinary Incontinence RCT Project Summary/Abstract Urinary urgency incontinence, involuntary urine loss associated with a sudden, compelling desire to urinate, is a common and costly public health problem without cure. Urgency incontinence increases with age and its sufferers are primarily women. These women have severely compromised quality of life from the stigma and humiliation of urgency incontinence. They have attendant depression and loss of work productivity, income and independence. They must bear the burden of medication costs, despite medication's limited effectiveness. Due to unprecedented growth of the U.S. population older than 65, urgency incontinence will consume 86.2 billion dollars by 2020. Finding successful, durable treatment for this burgeoning public health problem is an unmet need. This project will evaluate hypnotherapy treatment to meet this need. This proposal will compare efficacy of hypnotherapy to pharmacotherapy in urgency incontinence. Preliminary evidence supports pursuit of hypnotherapy in urgency incontinence treatment. Patients with functional disorders such as urgency incontinence respond differently to physiologic stimulus. This abnormal stress response, """"""""hyper-vigilance,"""""""" is associated with abnormal brain activation on functional brain imaging. Hypnotherapy offers the hope of modifying this abnormal response in urgency incontinence. A case series and our own pilot data support hypnotherapy's effectiveness in urgency incontinence. Therefore, the long term goal of this proposal is to shift focus of urgency incontinence treatment towards the brain and away from the peripheral nervous system, the target of pharmacotherapy. The objective of this application is to determine whether hypnotherapy can be more effective than current pharmacologic therapy of urgency incontinence. Its central hypothesis is that hypo- therapy modulates interactions between the brain and bladder, providing effective urgency incontinence treatment. This hypothesis will be tested pursuing 2 specific aims: 1) Determine whether a mind/body therapy (hypnotherapy) is a more effective and durable treatment of urgency urinary incontinence than a non- mind/body treatment (pharmacotherapy) 2) Determine whether hypnotherapy treatment of urgency urinary incontinence is associated with greater modification of limbic cortex activation and connectivity on functional MRI than that which occurs following pharmacotherapy. Urge incontinent women (N=152) will be randomized to medications or hypnotherapy and evaluated at months 2, 6 &12. Sixty women will undergo imaging before and after treatment. The rationale for the proposal is based on work which suggests that brain activation is abnormal in subjects with urgency incontinence, that urgency incontinence responds to hypnotherapy, and that the hypnotic state affects sites of abnormal brain activation. This proposal is significant because it seeks to treat urgency incontinence, a growing public health problem, with hypnotherapy, a mind/body intervention. This novel approach uses hypnotherapy to treat urgency incontinence and offers innovative use of brain imaging to elucidate hypnotherapy's mechanism of action and shifts the treatment paradigm from the bladder to the mind.
The proposed research is relevant to public health because it offers the potential of finding a durable and effective treatment for urgency incontinence, a costly and burgeoning public health problem which will increase over time. The positive impact of this work, relevant to the NIH mission, is that it defines a useful &safe mind/body intervention, hypnotherapy, to improve health of women affected by urgency incontinence, increases evidence-based knowledge of hypnotherapy's durability &efficacy in urgency incontinence treatment, and utilizes a translational research tool (functional magnetic resonance brain imaging) to build a biological foundation for study of hypnotherapy and other mind/body therapies. .
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