Clinical trial NCT02202031: Controlling Urgency Through Relaxation Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urgency Urinary Symptoms
Urgency Incontinence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-07-28
Enrollment: 161
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.
timeFrame: Baseline to 12 weeks.
measure: Change From Baseline in Total Voiding Episodes at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks
timeFrame: Baseline to 12 weeks.
measure: Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.
timeFrame: Baseline to 12 weeks.
measure: Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.
timeFrame: Baseline to 12 Weeks
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.
timeFrame: Baseline to 12 Weeks
measure: Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alison Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: