Clinical trial NCT01048424: Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
Official title: Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Urge
Keywords: Urinary incontinence
Paced respiration
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urgency incontinence is a common and burdensome problem in women. Current treatments for this condition, while effective, are associated with potentially disabling side effects and high rates of discontinuation. There is an urgent need for alternate treatments for urgency incontinence that are both clinically effective and well-tolerated by women in the community.

RESPeRATE is a commercially available "walkman-like" device that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the US Food and Drug Administration (FDA) for treatment of mild hypertension, and use of the device has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate. Because anxiety and stress are strongly associated with urgency incontinence, and common behavioral strategies for managing incontinence emphasize relaxation and slow breathing at the time of an urgency episode, paced respiration may also be useful in treating urgency incontinence and/or decreasing its burden on quality of life.

We propose to conduct a 6-week pilot randomized controlled trial of slow paced respiration using the RESPeRATE device among 30 women with urgency incontinence to assess the feasibility of recruiting and teaching women to use the RESPeRATE device as well as to gather preliminary data on the efficacy of slow paced respiration for treatment of urgency incontinence and related symptoms. Participants will complete a 7-day voiding diary and complete questionnaires to measure outcome.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 years or older who report urinary incontinence for greater than or equal to 3 months prior to screening
* Report that the majority of their incontinence episodes are associated with a sensation of urgency
* Record at least 7 urgency incontinence episodes per week on a screening 7-day voiding diary
* Able to walk to the toilet and use the toilet by themselves without difficulty
* Willing to refrain from initiating treatments that may affect their voiding pattern during the trial period
* Capable of understanding study procedures and giving informed consent

Exclusion Criteria:

* Current use of medical therapy for incontinence or use within the previous month (participants may be able to stop use of therapy and re-present for study)
* Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period (approximately 2 months)
* Current urinary tract infection (screening dipstick urinalysis with leukocyte estrace, nitrites or blood) or a history or 4 or more urinary tract infections in the preceding year
* Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, Parkinson's disease
* Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
* Report history of pulmonary disease including emphysema, chronic bronchitis, or chronic obstructive pulmonary disease
* Measured resting blood pressure (average of 2 measures) less than 100/60 at screening or baseline examination
* Report any history of prior anti-incontinence or urethral surgery, pelvic cancer, or pelvic irradiation for any reason
* Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
* Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) during the past 3 months
* Report conditions that, in the judgment of the clinical center Principal Investigator, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia
* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study

Primary outcomes:
measure: Percent Change in Urgency Urinary Incontinence Episodes Per Week
timeFrame: baseline to 6 weeks
Secondary outcomes:
measure: Percent Change in Any Urinary Incontinence Episodes Per Week
timeFrame: Baseline to 6 weeks
measure: Percent Change in Daytime Voiding Frequency.
timeFrame: Baseline to 6 weeks
measure: Change in Overactive Bladder Symptoms
timeFrame: Baseline to 6 weeks
measure: Change in Anxiety Symptoms
timeFrame: Baseline to 6 weeks
measure: Change in Depression Symptoms
timeFrame: Baseline to 6 weeks
measure: Change in Perceived Stress
timeFrame: Baseline to 6 weeks
measure: Change in Sleep Quality
timeFrame: Baseline to 6 weeks
measure: Change in Incontinence- or Bladder-specific Quality of Life
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF-Mt. Zion Women's Health Clinical Research Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alison Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: