Controlling Urgency Through Relaxation Exercises

Completed · Not applicable

Conditions studied: Overactive Bladder, Urgency Urinary Symptoms, Urgency Incontinence

In brief

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.

Key facts

Study ID

NCT02202031

Run by

University of California, San Francisco

People needed

161

Starts

2014-09-01

Expected to finish

2018-03-01

Last updated by the study team

2019-07-30

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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