Controlling Urgency Through Relaxation Exercises (CURE)

July 17, 2019 updated by: Alison Huang, MD, University of California, San Francisco
We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation therapies in 160 ambulatory women who report an average of at least 3 urgency-associated voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to: 1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least 15 minutes/day at home using a portable guided-breathing device; or 2) use an identical-appearing device that plays relaxing music while monitoring their spontaneous breathing pattern. We do not know if either of the two types of relaxation therapies is effective in treating OAB. All women will also receive a usual care pamphlet providing basic information about other traditional self-management strategies for OAB.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women aged 21 years or older who are able to walk to the bathroom without assistance
  2. Report recurrent episodes of urgency (sudden or strong urges to urinate) beginning at least 3 months prior to screening
  3. Able to record all voiding and incontinence episodes on a screening 3-day voiding diary29,30 and rate the severity of urgency associated with each episode using a validated urgency severity scale31
  4. Document at least 9 voiding or incontinence episodes on the above 3-day voiding diary that are associated with at least moderate sensation of urgency (using the above validated urgency severity scale) 31
  5. Willing to refrain from initiating other treatments that may affect voiding pattern during the trial period

Exclusion Criteria:

  1. Use of anticholinergic OAB medications or other medications known to affect urinary function (i.e., diuretics, tricyclic antidepressants) within 1 month of screening
  2. Current urinary tract infection (detected via screening dipstick urinalysis or urine culture) or a history more than 3 urinary tract infections in the preceding 1 year
  3. Prior history of lower urinary tract surgery, pelvic cancer, or pelvic irradiation; or other pelvic or abdominal surgery within 6 months of screening
  4. History of interstitial cystitis, fistula in the bladder or rectum, or congenital or childhood defect leading to chronic urinary incontinence, retention, or other chronic urinary symptoms
  5. Known history of major neurologic conditions likely to have major or permanent effects on bladder function such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease
  6. Use of bladder botulinum injections, electrostimulation, or other invasive therapies for OAB or incontinence within 3 months of screening
  7. Formal pelvic floor rehabilitation or other formal behavioral therapy for bladder symptoms involving a physical therapist or other certified practitioner within 3 months of screening
  8. Started, stopped, or changed dosage of a psychoactive medication likely to affect anxiety (SSRIs/SNRIs, tricyclics) within 3 months of screening, or plans to start, stop, or change dosage during the trial
  9. Resting blood pressure (average of 2 measures) less than 100/60 at screening (women with baseline low blood pressure may theoretically be at increased risk of hypotension with use of RESPeRATE)
  10. Resting breathing rate already below 10 breaths/minute before treatment (as measured during run-in)
  11. History of chronic pulmonary disease likely to interfere with breathing exercises (e.g., emphysema)
  12. Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period
  13. Unable or willing to sign an informed consent, fill out questionnaires, or undergo study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music Therapy
Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
Behavioral: Music Therapy
Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
Experimental: Paced Respiration
Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
Behavioral: Paced Respiration
Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.
Time Frame: Baseline to 12 weeks
Self-reported on voiding diary.
Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.
Time Frame: Baseline to 12 weeks
Self-reported on voiding diary
Baseline to 12 weeks
Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.
Time Frame: Baseline to 12 weeks.
Self-reported on voiding diary
Baseline to 12 weeks.
Change From Baseline in Total Voiding Episodes at 12 Weeks.
Time Frame: Baseline to 12 weeks
Self-reported on voiding diary.
Baseline to 12 weeks
Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks
Time Frame: Baseline to 12 weeks.
A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.
Baseline to 12 weeks.
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.
Time Frame: Baseline to 12 weeks.
A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.
Baseline to 12 weeks.
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.
Time Frame: Baseline to 12 weeks
A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.
Baseline to 12 weeks
Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.
Time Frame: Baseline to 12 weeks
A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.
Baseline to 12 weeks
Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.
Time Frame: Baseline to 12 weeks
A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.
Baseline to 12 weeks
Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.
Time Frame: Baseline to 12 Weeks
A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.
Baseline to 12 Weeks
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.
Time Frame: Baseline to 12 Weeks
A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.
Baseline to 12 Weeks
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.
Time Frame: Baseline to 12 weeks
A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.
Baseline to 12 weeks
Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.
Time Frame: Baseline to 12 weeks
A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.
Baseline to 12 weeks
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.
Time Frame: Baseline to 12 weeks
An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.
Baseline to 12 weeks
Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.
Time Frame: Baseline to 12 weeks
Resting (neutral) state
Baseline to 12 weeks
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.
Time Frame: Baseline to 12 weeks
Change in autonomic control as assessed by high frequency heart rate variability (RSA)
Baseline to 12 weeks
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.
Time Frame: Baseline to 12 weeks
High frequency heart rate variability
Baseline to 12 weeks
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks
Time Frame: Baseline to 12 weeks
high frequency heart rate variability
Baseline to 12 weeks
Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.
Time Frame: Baseline to 12 weeks
PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .
Baseline to 12 weeks
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.
Time Frame: Baseline to 12 weeks
The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed
Baseline to 12 weeks
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks
Time Frame: Baseline to 12 weeks
The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison Huang, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-13319
  • 1R01AG047894 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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