Urinary Incontinence, UrgeSPIRITNCT01048424
Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
A study testing RESPeRATE and Urinary Incontinence Pamphlet in people with Urinary Incontinence, Urge, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- RESPeRATE and Urinary Incontinence Pamphlet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF-Mt. Zion Women's Health Clinical Research Center
San Francisco, California, 94115
About this study
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.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- RESPeRATE, Urinary Incontinence Pamphlet
- Keywords
- Urinary incontinence, Paced respiration
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPeRATEDevice
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.
Urinary Incontinence PamphletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RESPeRATE; Other: Urinary Incontinence Pamphlet |
| Control | Placebo comparator | Participants will be given a Urinary Incontinence pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms. Receives: Other: Urinary Incontinence Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 6 weeks
Secondary outcomes (8)
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.
Measured: Baseline to 6 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Huang, University of California, San Francisco
- Investigators
- Alison Huang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048424
- Sponsor's protocol ID
- SPIRIT001
- Acronym
- SPIRIT
- Status last verified
- Oct 2013
- First submitted
- 11 Jan 2010
- Last updated
- 21 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
- ClinicalTrials.gov ID
- NCT01048424
- Acronym / sponsor ID
- SPIRIT / SPIRIT001
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Urinary incontinence, Paced respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 21 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paced respiration | Experimental | Device: RESPeRATE, Other: Urinary Incontinence PamphletParticipants 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 | Other: Urinary Incontinence PamphletParticipants will be given a Urinary Incontinence pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPeRATERESPeRATE 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. | Device | Paced respiration |
| Urinary Incontinence PamphletThe 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. | Other | Control, Paced respiration |
Primary outcome
Percent Change in Urgency Urinary Incontinence Episodes Per Week
Time frame: 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.
8 secondary outcomes
Percent Change in Any Urinary Incontinence Episodes Per Week
Time frame: Baseline to 6 weeks
Percent Change in Daytime Voiding Frequency.
Time frame: Baseline to 6 weeks
Change in Overactive Bladder Symptoms
Time frame: Baseline to 6 weeks
Change in Anxiety Symptoms
Time frame: Baseline to 6 weeks
Change in Depression Symptoms
Time frame: Baseline to 6 weeks
Change in Perceived Stress
Time frame: Baseline to 6 weeks
Change in Sleep Quality
Time frame: Baseline to 6 weeks
Change in Incontinence- or Bladder-specific Quality of Life
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Huang, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPeRATE and Urinary Incontinence Pamphlet in people with Urinary Incontinence, Urge, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Urgency Urinary Incontinence Episodes Per Week (time frame: baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.