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Completed

NCT Number: NCT01048424

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percent Change in Any 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.

  2. Percent Change in Daytime Voiding Frequency.

    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.

  3. Change in Overactive Bladder Symptoms

    Time frame: 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.

  4. Change in Anxiety Symptoms

    Time frame: 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.

  5. Change in Depression Symptoms

    Time frame: Baseline to 6 weeks

    Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).

  6. Change in Perceived Stress

    Time frame: Baseline to 6 weeks

    Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.

  7. Change in Sleep Quality

    Time frame: 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.

  8. Change in Incontinence- or Bladder-specific Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: SPIRIT

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2010
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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