Controlling Urgency Through Relaxation Exercises

Study Overview
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Brief Summary
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We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation therapies in 160 ambulatory women who report an average of at least 3 urgency-associated voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to: 1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least 15 minutes/day at home using a portable guided-breathing device; or 2) use an identical-appearing device that plays relaxing music while monitoring their spontaneous breathing pattern. We do not know if either of the two types of relaxation therapies is effective in treating OAB. All women will also receive a usual care pamphlet providing basic information about other traditional self-management strategies for OAB.

Conditions
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Overactive Bladder, Urgency Urinary Symptoms, Urgency Incontinence

Intervention / Treatment
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* Behavioral: Paced Respiration
* Behavioral: Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 21 years or older who are able to walk to the bathroom without assistance Report recurrent episodes of urgency (sudden or strong urges to urinate) beginning at least 3 months prior to screening Able to record all voiding and incontinence episodes on a screening 3-day voiding diary29,30 and rate the severity of urgency associated with each episode using a validated urgency severity scale31 Document at least 9 voiding or incontinence episodes on the above 3-day voiding diary that are associated with at least moderate sensation of urgency (using the above validated urgency severity scale) 31 Willing to refrain from initiating other treatments that may affect voiding pattern during the trial period Exclusion Criteria: Use of anticholinergic OAB medications or other medications known to affect urinary function (i.e., diuretics, tricyclic antidepressants) within 1 month of screening Current urinary tract infection (detected via screening dipstick urinalysis or urine culture) or a history more than 3 urinary tract infections in the preceding 1 year Prior history of lower urinary tract surgery, pelvic cancer, or pelvic irradiation; or other pelvic or abdominal surgery within 6 months of screening History of interstitial cystitis, fistula in the bladder or rectum, or congenital or childhood defect leading to chronic urinary incontinence, retention, or other chronic urinary symptoms Known history of major neurologic conditions likely to have major or permanent effects on bladder function such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease Use of bladder botulinum injections, electrostimulation, or other invasive therapies for OAB or incontinence within 3 months of screening Formal pelvic floor rehabilitation or other formal behavioral therapy for bladder symptoms involving a physical therapist or other certified practitioner within 3 months of screening Started, stopped, or changed dosage of a psychoactive medication likely to affect anxiety (SSRIs/SNRIs, tricyclics) within 3 months of screening, or plans to start, stop, or change dosage during the trial Resting blood pressure (average of 2 measures) less than 100/60 at screening (women with baseline low blood pressure may theoretically be at increased risk of hypotension with use of RESPeRATE) Resting breathing rate already below 10 breaths/minute before treatment (as measured during run-in) History of chronic pulmonary disease likely to interfere with breathing exercises (e.g., emphysema) Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period Unable or willing to sign an informed consent, fill out questionnaires, or undergo study procedures

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy<br>Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. | Behavioral: Music Therapy<br>* Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.<br>|
| Experimental: Paced Respiration<br>Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. | Behavioral: Paced Respiration<br>* Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks. | Self-reported on voiding diary. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks. | Self-reported on voiding diary | Baseline to 12 weeks | 
| Change From Baseline in Urgency Incontinence Episodes at 12 Weeks. | Self-reported on voiding diary | Baseline to 12 weeks. | 
| Change From Baseline in Total Voiding Episodes at 12 Weeks. | Self-reported on voiding diary. | Baseline to 12 weeks | 
| Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks | A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome. | Baseline to 12 weeks. | 
| Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks. | A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe. | Baseline to 12 weeks. | 
| Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks. | A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life. | Baseline to 12 weeks | 
| Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks. | A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress. | Baseline to 12 weeks | 
| Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks. | A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe. | Baseline to 12 weeks | 
| Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks. | A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety. | Baseline to 12 Weeks | 
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks. | A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety. | Baseline to 12 Weeks | 
| Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks. | A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression. | Baseline to 12 weeks | 
| Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks. | A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress. | Baseline to 12 weeks | 
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks. | An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality. | Baseline to 12 weeks | 
| Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks. | Resting (neutral) state | Baseline to 12 weeks | 
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks. | Change in autonomic control as assessed by high frequency heart rate variability (RSA) | Baseline to 12 weeks | 
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks. | High frequency heart rate variability | Baseline to 12 weeks | 
| Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks | high frequency heart rate variability | Baseline to 12 weeks | 
| Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks. | PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography . | Baseline to 12 weeks | 
| Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks. | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Baseline to 12 weeks | 
| Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks | The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed | Baseline to 12 weeks |