Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alison Huang, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01048424
First received: January 11, 2010
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Urinary Incontinence, Urge
Device: RESPeRATE
Other: Urinary Incontinence Pamphlet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Percent Change in Urgency Urinary Incontinence Episodes Per Week [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
    The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.


Secondary Outcome Measures:
  • Percent Change in Any Urinary Incontinence Episodes Per Week [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.

  • Percent Change in Daytime Voiding Frequency. [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.

  • Change in Overactive Bladder Symptoms [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    The Overactive Bladder Questionnaire (OAB-Q). 0- to 100-point scale. Higher scores on the OAB-Q indicate greater bothersomeness and impact of overactive bladder symptoms.

  • Change in Anxiety Symptoms [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale. Anxiety Subscale range from 0 to 21, with scores of less than 8 indicative of absence of anxiety symptoms, 8 or above suggesting anxiety symptoms, and 12 or above suggesting generalized anxiety disorder.

  • Change in Depression Symptoms [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).

  • Change in Perceived Stress [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.

  • Change in Sleep Quality [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index. A global sleep quality score derived from the PSQI can be used to index overall quality of sleep over the prior one-week period. Global sleep quality scores are continuous (range 0-21), with high scores reflecting poor sleep quality.

  • Change in Incontinence- or Bladder-specific Quality of Life [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.


Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paced respiration
Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a Urinary Incontinence pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Device: RESPeRATE
RESPeRATE is a commercially available, "walkman-like" device manufactured by Intercure, Ltd. 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 FDA for treatment of mild hypertension and has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate.
Other: Urinary Incontinence Pamphlet
The urinary incontinence pamphlet will provide information about classification, pathophysiology, and management of urinary incontinence, including management strategies such as timed urination and pelvic muscle exercises.
Placebo Comparator: Control
Participants will be given a Urinary Incontinence pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Other: Urinary Incontinence Pamphlet
The urinary incontinence pamphlet will provide information about classification, pathophysiology, and management of urinary incontinence, including management strategies such as timed urination and pelvic muscle exercises.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048424

Locations
United States, California
UCSF-Mt. Zion Women's Health Clinical Research Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Alison Huang, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Alison Huang, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01048424     History of Changes
Other Study ID Numbers: SPIRIT001
Study First Received: January 11, 2010
Results First Received: May 22, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Urinary incontinence
Paced respiration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014