Controlling Urgency Through Relaxation Exercises



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - Any
Updated:5/3/2018
Start Date:September 2014
End Date:March 2018

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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.


Inclusion Criteria:

1. Women aged 21 years or older who are able to walk to the bathroom without assistance

2. Report recurrent episodes of urgency (sudden or strong urges to urinate) beginning at
least 3 months prior to screening

3. 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

4. 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

5. Willing to refrain from initiating other treatments that may affect voiding pattern
during the trial period

Exclusion Criteria:

1. Use of anticholinergic OAB medications or other medications known to affect urinary
function (i.e., diuretics, tricyclic antidepressants) within 1 month of screening

2. 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

3. Prior history of lower urinary tract surgery, pelvic cancer, or pelvic irradiation; or
other pelvic or abdominal surgery within 6 months of screening

4. 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

5. 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

6. Use of bladder botulinum injections, electrostimulation, or other invasive therapies
for OAB or incontinence within 3 months of screening

7. 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

8. 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

9. 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)

10. Resting breathing rate already below 10 breaths/minute before treatment (as measured
during run-in)

11. History of chronic pulmonary disease likely to interfere with breathing exercises
(e.g., emphysema)

12. Currently pregnant, gave birth within the past 3 months, or planning pregnancy during
the study period

13. Unable or willing to sign an informed consent, fill out questionnaires, or undergo
study procedures
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Alison Huang, MD
Phone: 415-885-7547
?
mi
from
San Francisco, CA
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