Trial Outcomes & Findings for Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT) (NCT NCT01048424)
NCT ID: NCT01048424
Last Updated: 2013-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
baseline to 6 weeks
Results posted on
2013-11-21
Participant Flow
Participant milestones
| Measure |
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 pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
Usual Care
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
Baseline characteristics by cohort
| Measure |
Paced Respiration
n=10 Participants
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.
|
Usual Care
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age Continuous
|
56.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
54.73 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
56 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 weeksThe 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.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Percent Change in Urgency Urinary Incontinence Episodes Per Week
|
-33 Percent Change
Standard Deviation 40
|
-6 Percent Change
Standard Deviation 50
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThe 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.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Percent Change in Any Urinary Incontinence Episodes Per Week
|
-18 Percent Change
Standard Deviation 40
|
-2 Percent Change
Standard Deviation 40
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThe 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.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Percent Change in Daytime Voiding Frequency.
|
-9 Percent Change
Standard Deviation 20
|
3 Percent Change
Standard Deviation 30
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThe 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.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Change in Overactive Bladder Symptoms
|
-.63 Score on a Scale
Standard Deviation 0.9
|
-.44 Score on a Scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksHospital 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.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Change in Anxiety Symptoms
|
-.78 Score on a Scale
Standard Deviation 2.4
|
-.57 Score on a Scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksBeck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Change in Depression Symptoms
|
-2.67 Score on a Scale
Standard Deviation 3.7
|
2.25 Score on a Scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksCohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Change in Perceived Stress
|
-1.13 Score on a Scale
Standard Deviation 3.5
|
4.13 Score on a Scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksThe 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.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Change in Sleep Quality
|
-1.43 Score on a Scale
Standard Deviation 2.0
|
-.38 Score on a Scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksIncontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.
Outcome measures
| Measure |
Paced Respiration
n=8 Participants
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.
|
Control
n=10 Participants
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Change in Incontinence- or Bladder-specific Quality of Life
|
-.15 Score on a Scale
Standard Deviation 0.5
|
-.06 Score on a Scale
Standard Deviation 0.7
|
Adverse Events
Paced Respiration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paced Respiration
n=8 participants at risk
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.
|
Usual Care
n=10 participants at risk
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Cough
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Headache Issues
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Increased Fatigue Issues
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/8
|
37.5%
3/8 • Number of events 3
|
|
Nervous system disorders
Light-Headedness Issues
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Rapid Heart Beat Issues
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Swelling of both feet
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
Additional Information
Alison Huang, MD
University of California, San Francisco
Phone: 415-353-9751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place