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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paced respiration | Experimental | 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. |
|
| Control | Placebo Comparator | Participants will be given a Urinary Incontinence pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESPeRATE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percent Change in Daytime Voiding Frequency. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Huang, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF-Mt. Zion Women's Health Clinical Research Center | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percent Change | baseline to 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Huang, MD | University of California, San Francisco | 415-353-9751 | ahuang@medicine.ucsf.edu |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Urinary Incontinence Pamphlet | Other | 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Usual Care |
Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline to 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline to 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to 6 weeks |
|
|
|
| Secondary | Change in Depression Symptoms | Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe). | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to 6 weeks |
|
|
|
| Secondary | Change in Perceived Stress | Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to 6 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to 6 weeks |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Usual Care | Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms. | 0 | 10 | 6 | 10 |
| Cough | Infections and infestations |
|
| Headache Issues | Nervous system disorders |
|
| Increased Fatigue Issues | General disorders |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders |
|
| Light-Headedness Issues | Nervous system disorders |
|
| Lower Back Pain | Musculoskeletal and connective tissue disorders |
|
| Rapid Heart Beat Issues | Investigations |
|
| Skin Rash | Skin and subcutaneous tissue disorders |
|
| Swelling of both feet | General disorders |
|
| Urinary Tract Infection | Investigations |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |