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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01048424

Acronym

SPIRIT

Enrollment

Registered

2010-01-13

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Urge

Keywords

Urinary incontinence, Paced respiration

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.

Interventions

DEVICERESPeRATE

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.

OTHERUrinary Incontinence Pamphlet

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Urgency Urinary Incontinence Episodes Per Week	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.

Secondary

Measure	Time frame	Description
Percent Change in Any Urinary Incontinence Episodes Per Week	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.
Change in Overactive Bladder Symptoms	Baseline to 6 weeks	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 Perceived Stress	Baseline to 6 weeks	Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.
Percent Change in Daytime Voiding Frequency.	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.
Change in Depression Symptoms	Baseline to 6 weeks	Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).
Change in Sleep Quality	Baseline to 6 weeks	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	Baseline to 6 weeks	Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.
Change in Anxiety Symptoms	Baseline to 6 weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	10
Usual Care Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.	10
Total	20

Baseline characteristics

Characteristic	Usual Care	Paced Respiration	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4 Participants	2 Participants	6 Participants
Age, Categorical Between 18 and 65 years	6 Participants	8 Participants	14 Participants
Age Continuous	54.73 years STANDARD_DEVIATION 16.8	56.7 years STANDARD_DEVIATION 10.9	56 years STANDARD_DEVIATION 15
Region of Enrollment United States	10 participants	10 participants	20 participants
Sex: Female, Male Female	10 Participants	10 Participants	20 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 8	6 / 10
serious Total, serious adverse events	0 / 8	0 / 10

Outcome results

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.

Time frame: baseline to 6 weeks

Arm	Measure	Value (MEAN)	Dispersion
Paced Respiration	Percent Change in Urgency Urinary Incontinence Episodes Per Week	-33 Percent Change	Standard Deviation 40
Control	Percent Change in Urgency Urinary Incontinence Episodes Per Week	-6 Percent Change	Standard Deviation 50

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.