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

Urinary Incontinence, Urge Clinical Trial

— SPIRIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048424
• Other study ID #: SPIRIT001
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: October 29, 2013
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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.

Locations

Country	Name	City	State
United States	UCSF-Mt. Zion Women's Health Clinical Research Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Urgency Urinary Incontinence Episodes Per Week	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.	baseline to 6 weeks	No
Secondary	Percent Change in Any Urinary Incontinence Episodes Per Week	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.	Baseline to 6 weeks	No
Secondary	Percent Change in Daytime Voiding Frequency.	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.	Baseline to 6 weeks	No
Secondary	Change in Overactive Bladder Symptoms	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.	Baseline to 6 weeks	No
Secondary	Change in Anxiety Symptoms	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.	Baseline to 6 weeks	No
Secondary	Change in Depression Symptoms	Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).	Baseline to 6 weeks	No
Secondary	Change in Perceived Stress	Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.	Baseline to 6 weeks	No
Secondary	Change in Sleep Quality	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.	Baseline to 6 weeks	No
Secondary	Change in Incontinence- or Bladder-specific Quality of Life	Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.	Baseline to 6 weeks	No