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

Primary Purpose

Stress Incontinence, Female, Stress Incontinence, Urinary, Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Practice Program
Physical Conditioning Program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Incontinence, Female

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga Practice Program

Physical Conditioning Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Total Urinary Incontinence Episodes
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 Outcome Measures

Change From Baseline in Stress-Type Urinary Incontinence Episodes
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
Change From Baseline in Urgency-Type Urinary Incontinence Episodes
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
Change From Baseline in Incontinence Impact Questionnaire (IIQ)
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
Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)
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
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
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
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
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
Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
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
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
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
Change From Baseline in Perceived Stress Scale (PSS) Score
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
Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score
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
Change From Baseline in One-legged Balance Test (Winsorized)
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.
Change From Baseline in Chair Stands (in 30 Seconds)
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
Change From Baseline in 2-Minute Step Test
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
Change From Baseline in Wake After Sleep Onset (Winsorized)
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.
Change From Baseline in Total Sleep Time
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.
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
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.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality
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
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)
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

Full Information

First Posted
September 13, 2018
Last Updated
September 5, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03672461
Brief Title
A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Official Title
A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Incontinence, Female, Stress Incontinence, Urinary, Stress Incontinence, Urge Incontinence, Urinary Incontinence, Stress, Urinary Stress Incontinence, Urgency Urinary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Practice Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Conditioning Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga Practice Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Conditioning Program
Intervention Description
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 Measure Information:
Title
Change From Baseline in Total Urinary Incontinence Episodes
Description
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.
Time Frame
Repeated change from baseline to 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Stress-Type Urinary Incontinence Episodes
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Urgency-Type Urinary Incontinence Episodes
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Incontinence Impact Questionnaire (IIQ)
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Perceived Stress Scale (PSS) Score
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in One-legged Balance Test (Winsorized)
Description
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.
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Chair Stands (in 30 Seconds)
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in 2-Minute Step Test
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Wake After Sleep Onset (Winsorized)
Description
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.
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Total Sleep Time
Description
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.
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
Description
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.
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks
Title
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)
Description
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
Time Frame
Repeated change from baseline to 6 and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Huang, MS, MAS, MPhil
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35167358
Citation
Huang AJ, Chesney MA, Schembri M, Pawlowsky S, Nicosia F, Subak LL. Rapid Conversion of a Group-Based Yoga Trial for Diverse Older Women to Home-Based Telehealth: Lessons Learned Using Zoom to Deliver Movement-Based Interventions. J Integr Complement Med. 2022 Feb;28(2):188-192. doi: 10.1089/jicm.2021.0268. Epub 2022 Jan 10.
Results Reference
derived

Learn more about this trial

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

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