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A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672461
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : May 11, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women and explore potential mediators of improvement in outcomes. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria will be recruited from multiple locations surrounding the San Francisco Bay area.

Condition or disease Intervention/treatment Phase
Stress Incontinence, Female Stress Incontinence, Urinary Stress Incontinence Urge Incontinence Urinary Incontinence, Stress Urinary Stress Incontinence Urgency Urinary Other: Yoga Practice Program Other: Physical Conditioning Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga Practice Program
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications.
Other: Yoga Practice Program
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.

Active Comparator: Physical Conditioning Program
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels.
Other: Physical Conditioning Program
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.




Primary Outcome Measures :
  1. Frequency of any urinary incontinence episodes [ Time Frame: 3 months ]
    Change in frequency of incontinence will be assessed using a standardized, validated voiding diary that has been shown to be a reliable method for assessing frequency and type of incontinence, is recommended by the FDA as a primary outcome measure for incontinence therapy trials and is sensitive to change for a variety of incontinence treatments.


Secondary Outcome Measures :
  1. Frequency of stress-type urinary incontinence episodes [ Time Frame: 3 months ]
    Change in frequency of any incontinence episodes will also be used to assess change in frequency of stress-type incontinence episodes

  2. Frequency of urgency-type urinary incontinence episodes [ Time Frame: 3 months ]
    assess change in frequency of any incontinence episodes will also be used to assess change in frequency of urgency-type incontinence episodes

  3. Incontinence Impact Questionnaire score [ Time Frame: 3 months ]
    assess change in incontinence-related functioning and quality of life, participants will complete the Incontinence Impact Questionnaire (IIQ)-- a validated, 28-item self-report measure of the impact of incontinence on 4 domains of functioning and quality of life (physical activity, emotional health, relationships, and travel)

  4. Urogenital Distress Inventory-6 score [ Time Frame: 3 months ]
    assess change in incontinence-related functioning and quality of life, participants will also complete the Urogenital Distress Inventory-6 (UDI-6)-- a validated, 6-item self-report measure that assesses subjective distress from frequent urination, urgency incontinence, stress incontinence, small-volume leakage, difficulty emptying the bladder, and genital pain

  5. Patient Perception of Bladder Condition score [ Time Frame: 3 months ]
    assess change in incontinence-related functioning and quality of life, participants will also complete the Patient Perception of Bladder Condition (PPBC)-- a validated single-item self-report measure assessing the degree to which respondents consider their condition to be a problem on a 6-point scale, widely used in clinical studies of both behavioral and pharmacologic incontinence treatments.

  6. Depression symptoms [ Time Frame: 3 months ]
    Depressive symptoms will be assessed by the Center for Epidemiologic Studies Depression (CES-D) scale, a validated 20-item self-administered questionnaire measure that has been widely used in clinical trials, including trials of bladder interventions, and has been shown to be sensitive to change.

  7. Somatic anxiety [ Time Frame: 3 months ]
    Somatic anxiety (i.e., the affective component of anxiety believed to be related to autonomic physiological arousal response) will be measured using the trait component of the Spielberger State Trait Anxiety Inventory (STAI), a 20-item self-administered measure validated in clinical populations, including patients with bladder symptoms.

  8. Cognitive anxiety [ Time Frame: 3 months ]
    Cognitive anxiety (i.e., the mental component of anxiety associated with fear of failure) will be measured by the Hospital Anxiety and Depression Scale (HADS), a validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials.

  9. Perceived Stress [ Time Frame: 3 months ]
    Perceived stress will be measured by the Perceived Stress Scale (PSS), a 10-item measure of thoughts and feelings related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40; higher scores indicated greater stress.

  10. Incontinence-related sexual function [ Time Frame: 3 months ]
    Sexual function related to urinary incontinence will be measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), validated 20-item measure of sexual function in women with pelvic floor disorders (PFDs), designed to be appropriate for both sexually active and inactive women. The global quality sub-scale has a score range from 1 to 4.75, with higher scores indicating worse quality.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 45 years or older who report urinary incontinence starting at least 3 months prior to screening
  • Self-report an average of at least one incontinence episode per day on a validated voiding diary
  • Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary
  • Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period

Exclusion Criteria:

  • Current participation in organized yoga classes or workshops, or any prior organized yoga training directed specifically at improving incontinence
  • Current participation in organized physical conditioning classes involving muscle strengthening exercises (e.g., Pilates)
  • Current urinary tract infection or hematuria detected by urinalysis at screening visit (women can re-present after evaluation and treatment through their usual care)
  • Currently pregnant (by self-report or screening urine pregnancy test), gave birth within the past 3 months, or planning pregnancy during the study period
  • Report use of medical devices (i.e. pessary) for incontinence within the past month (participants may stop use of device and re-present for study)
  • Report use of bladder botox, electrostimulation, formal bladder training, or formal pelvic floor exercise training (with certified practitioners) in the past 3 months
  • Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation
  • Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
  • Unable to walk 2 blocks on level ground without assistance (functional capacity < 4 metabolic equivalents)
  • Unable to get up from a supine to a standing position without assistance (assessed during the screening visit)
  • Report history of interstitial cystitis, bladder or rectal fistula, or congenital defect causing urinary incontinence
  • Report incontinence caused by a major neurologic conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease
  • Report use of medications with strong effects on urination (anticholinergic bladder medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics) within the past month
  • Report starting, stopping, or changing the dose of a medication with the potential to affect anxiety or depression symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period
  • Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
  • Unable to understand study procedures, complete study interviews, or and provide informed consent in English
  • Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672461


Contacts
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Contact: Alison Huang, MD, MAS, MPhil 415-514-8697 Alison.Huang@ucsf.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Leslee Subak, MD    650-723-5533    lsubak@stanford.edu   
Contact: Kathryn Batham    650-724-7826    kbatham@stanford.edu   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Traci Coggins Plaut    415-885-7547    Traci.Plaut@ucsf.edu   
Contact: Amy Du    415-885-7547    amy.du@ucsf.edu   
Principal Investigator: Alison Huang, MD         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Investigators
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Principal Investigator: Alison Huang, MS, MAS, MPhil University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03672461    
Other Study ID Numbers: P0529491
R01DK116712-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders