Status:
COMPLETED
Controlling Urgency Through Relaxation Exercises
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Overactive Bladder
Urgency Urinary Symptoms
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
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 incontinenc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT02202031
Start Date
September 1 2014
End Date
March 1 2018
Last Update
July 30 2019
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94115