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

Sponsor
University of California, San Francisco (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03672461
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Stanford University (Other)
240
2
2
45.9
120
2.6

Study Details

Study Description

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
  • Other: Yoga Practice Program
  • Other: Physical Conditioning Program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
240 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 :
Mar 6, 2019
Actual Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Frequency of any urinary incontinence episodes [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94305
2 University of California, San Francisco San Francisco California United States 94115

Sponsors and Collaborators

  • University of California, San Francisco
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Stanford University

Investigators

  • Principal Investigator: Alison Huang, MS, MAS, MPhil, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03672461
Other Study ID Numbers:
  • P0529491
  • R01DK116712-01A1
First Posted:
Sep 14, 2018
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022