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Completed

NCT Number: NCT03672461

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

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Yoga Practice Program

Other

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.

Physical Conditioning Program

Other

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 outcomes

  1. Change From Baseline in Total Urinary Incontinence Episodes

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points.

Secondary outcomes

  1. Change From Baseline in Stress-Type Urinary Incontinence Episodes

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points

  2. Change From Baseline in Urgency-Type Urinary Incontinence Episodes

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points

  3. Change From Baseline in Incontinence Impact Questionnaire (IIQ)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-400, Higher score indicates lower quality of life

  4. Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-100, Higher score indicates lower quality of life

  5. Change From Baseline in Patient Perception of Bladder Condition (PPBC)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range 1-6, Higher score indicates lower quality of life

  6. Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-60, Higher score indicates lower quality of life

  7. Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 20-80, Higher score indicates lower quality of life

  8. Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-21, Higher score indicates lower quality of life

  9. Change From Baseline in Perceived Stress Scale (PSS) Score

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-40, Higher score indicates lower quality of life

  10. Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points (Mean 50, Std Dev 10) no widely accepted thresholds have been published. Higher score indicates better quality of life

  11. Change From Baseline in One-legged Balance Test (Winsorized)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life.

  12. Change From Baseline in Chair Stands (in 30 Seconds)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life

  13. Change From Baseline in 2-Minute Step Test

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life

  14. Change From Baseline in Wake After Sleep Onset (Winsorized)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the follow-up value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points.

    Higher score indicates lower quality of life.

  15. Change From Baseline in Total Sleep Time

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.

    Higher score indicates better quality of life.

  16. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.

    Range of 0-21, higher score indicates lower quality of life.

  17. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  18. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  19. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  20. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  21. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  22. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  23. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  24. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  25. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  26. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

  27. Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)

    Time frame: Repeated change from baseline to 6 and 12 weeks

    Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Stanford University

Registry information

Official study title

A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2018
Registry last updated
Mar 30, 2025

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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