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

Primary Purpose

Urinary Incontinence, Urge

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RESPeRATE
Urinary Incontinence Pamphlet
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Urinary incontinence, Paced respiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF-Mt. Zion Women's Health Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paced respiration

Control

Arm 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 Urinary Incontinence pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.

Participants will be given a Urinary Incontinence pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Change in Depression Symptoms
Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).
Change in Perceived Stress
Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.
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.
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.

Full Information

First Posted
January 11, 2010
Last Updated
October 29, 2013
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01048424
Brief Title
Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
Acronym
SPIRIT
Official Title
Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
Urinary incontinence, Paced respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paced respiration
Arm Type
Experimental
Arm 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 Urinary Incontinence pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will be given a Urinary Incontinence pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
Intervention Type
Device
Intervention Name(s)
RESPeRATE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Urinary Incontinence Pamphlet
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Huang, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF-Mt. Zion Women's Health Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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

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