Controlling Urgency Through Relaxation Exercises

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