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

NCT01048424 | Completed Results

• 1 other identifier: SPIRIT001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Urge

Keywords

Urinary incontinence; Paced respiration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Percent Change in Any Urinary Incontinence Episodes Per Week

  Baseline to 6 weeks

• Percent Change in Daytime Voiding Frequency.

  Baseline to 6 weeks

• Change in Overactive Bladder Symptoms

  Baseline to 6 weeks

• Change in Anxiety Symptoms

  Baseline to 6 weeks

• Change in Depression Symptoms

  Baseline to 6 weeks

Study Arms (2)

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.

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.

Other: Urinary Incontinence Pamphlet

Interventions

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.

Paced respiration

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.

Control; Paced respiration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

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

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alison Huang, MD
• Organization: University of California, San Francisco

ahuang@medicine.ucsf.edu

415-353-9751

Study Officials

• Alison Huang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 21, 2013
• Results First Posted: November 21, 2013

Record last verified: 2013-10

Locations

US (1)