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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01048424
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Urge	Device: RESPeRATE; Other: Urinary Incontinence Pamphlet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Percent Change in Urgency Urinary Incontinence Episodes Per Week [baseline to 6 weeks]

   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

1. Percent Change in Any Urinary Incontinence Episodes Per Week [Baseline to 6 weeks]

   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.

2. Percent Change in Daytime Voiding Frequency. [Baseline to 6 weeks]

   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.

3. Change in Overactive Bladder Symptoms [Baseline to 6 weeks]

   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.

4. Change in Anxiety Symptoms [Baseline to 6 weeks]

   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.

5. Change in Depression Symptoms [Baseline to 6 weeks]

   Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).

6. Change in Perceived Stress [Baseline to 6 weeks]

   Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.

7. Change in Sleep Quality [Baseline to 6 weeks]

   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.

8. Change in Incontinence- or Bladder-specific Quality of Life [Baseline to 6 weeks]

   Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alison Huang, Assistant Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01048424
• Other Study ID Numbers: SPIRIT001
• First Posted: Jan 13, 2010
• Last Update Posted: Nov 21, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Alison Huang, Assistant Professor, University of California, San Francisco: Urinary incontinence; Paced respiration
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge

Study Results

Participant Flow

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Period Title: Overall Study
STARTED	10	10
COMPLETED	8	10
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Paced Respiration	Usual Care	Total
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 80%	6 60%	14 70%
>=65 years	2 20%	4 40%	6 30%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.7 (10.9)	54.73 (16.8)	56 (15)
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	20 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Urgency Urinary Incontinence Episodes Per Week
Description	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.
Time Frame	baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Control
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Percent Change]	-33 (40)	-6 (50)

2. Secondary Outcome

Title	Percent Change in Any Urinary Incontinence Episodes Per Week
Description	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.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Percent Change]	-18 (40)	-2 (40)

3. Secondary Outcome

Title	Percent Change in Daytime Voiding Frequency.
Description	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.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Percent Change]	-9 (20)	3 (30)

4. Secondary Outcome

Title	Change in Overactive Bladder Symptoms
Description	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.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Score on a Scale]	-.63 (0.9)	-.44 (0.8)

5. Secondary Outcome

Title	Change in Anxiety Symptoms
Description	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.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Score on a Scale]	-.78 (2.4)	-.57 (4.6)

6. Secondary Outcome

Title	Change in Depression Symptoms
Description	Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Score on a Scale]	-2.67 (3.7)	2.25 (4.3)

7. Secondary Outcome

Title	Change in Perceived Stress
Description	Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Score on a Scale]	-1.13 (3.5)	4.13 (7.2)

8. Secondary Outcome

Title	Change in Sleep Quality
Description	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.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Score on a Scale]	-1.43 (2.0)	-.38 (2.4)

9. Secondary Outcome

Title	Change in Incontinence- or Bladder-specific Quality of Life
Description	Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.
Time Frame	Baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paced Respiration	Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Measure Participants	8	10
Mean (Standard Deviation) [Score on a Scale]	-.15 (0.5)	-.06 (0.7)

Adverse Events

Arm/Group Title	Paced Respiration		Usual Care
Arm/Group Description	Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.		Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
All Cause Mortality
	Paced Respiration		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Paced Respiration		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Paced Respiration		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)		6/10 (60%)
Gastrointestinal disorders
Abdominal Pain	0/8 (0%)	0	1/8 (12.5%)	1
General disorders
Increased Fatigue Issues	1/8 (12.5%)	1	0/8 (0%)	0
Swelling of both feet	0/8 (0%)	0	1/8 (12.5%)	1
Infections and infestations
Cough	1/8 (12.5%)	1	2/8 (25%)	2
Investigations
Rapid Heart Beat Issues	1/8 (12.5%)	1	0/8 (0%)	0
Urinary Tract Infection	1/8 (12.5%)	1	0/8 (0%)	0
Musculoskeletal and connective tissue disorders
Lower Back Pain	0/8 (0%)	0	1/8 (12.5%)	1
Nervous system disorders
Headache Issues	0/8 (0%)	0	1/8 (12.5%)	1
Light-Headedness Issues	1/8 (12.5%)	1	0/8 (0%)	0
Respiratory, thoracic and mediastinal disorders
Laryngitis	0/8 (0%)	0	3/8 (37.5%)	3
Skin and subcutaneous tissue disorders
Skin Rash	0/8 (0%)	0	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.