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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK116712-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Stanford University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Practice Program | Experimental | 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. |
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| Physical Conditioning Program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Repeated change from baseline to 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Repeated change from baseline to 6 and 12 weeks |
| Change From Baseline in Urgency-Type Urinary Incontinence Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Huang, MS, MAS, MPhil | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42348866 | Derived | Yang N, Shatkin-Margolis A, Subak LL, Chesney M, Lisha NE, Schembri M, Ackerman AL, Huang AJ. Beyond the bladder: incontinence-specific, physical, and psychological contributors to sexual function in women with urinary incontinence. J Sex Med. 2026 Jun 5;23(7):qdag175. doi: 10.1093/jsxmed/qdag175. | |
| 41359336 | Derived | Hough E, Goldstein LA, Subak LL, Chesney MA, Schembri M, Raghunathan H, Balys Pawlowsky S, Huang AJ. Effects of Hatha Yoga vs Physical Conditioning on Sleep in Women With Urinary Incontinence: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2546499. doi: 10.1001/jamanetworkopen.2025.46499. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2023 |
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| 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. |
|
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 |
| Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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. | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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. | Repeated change from baseline to 6 and 12 weeks |
| 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. | Repeated change from baseline to 6 and 12 weeks |
| 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. | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| 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 | Repeated change from baseline to 6 and 12 weeks |
| San Francisco |
| California |
| 94115 |
| United States |
| 39186785 | Derived | Huang AJ, Chesney M, Schembri M, Raghunathan H, Vittinghoff E, Mendes WB, Pawlowsky S, Subak LL. Efficacy of a Therapeutic Pelvic Yoga Program Versus a Physical Conditioning Program on Urinary Incontinence in Women : A Randomized Trial. Ann Intern Med. 2024 Oct;177(10):1339-1349. doi: 10.7326/M23-3051. Epub 2024 Aug 27. |
| 35167358 | Derived | 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. |
| FG001 | 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. 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Total Urinary Incontinence Episodes | Mean | Standard Deviation | episodes per day |
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| Stress-Type Urinary Incontinence Episodes | Mean | Standard Deviation | episodes per day |
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| Urgency-Type Urinary Incontinence Episodes | Mean | Standard Deviation | episodes per day |
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| Incontinence Impact Questionnaire (IIQ) | Range 0-400, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| Urogenital distress inventory-6 score (UDI) | Range 0-100, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| Patient Perception of Bladder Condition (PPBC) | Range 1-6, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| Center for Epidemiologic Studies Depression Scale (CES-D) | Range 0-60, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| State/Trait Anxiety Inventory (STAI)--Trait | Range 20-80, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| Hospital Anxiety & Depression (HADS)--Anxiety score | Range 0-21, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| Perceived Stress Scale (PSS) score | Range 0-40, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| PROMIS Physical 8B, T-Score | (mean 50, Std Dev 10) no widely accepted thresholds have been published. Range 20.9-59.7, Higher score indicates better quality of life. | Mean | Standard Deviation | T-Score |
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| One-legged Balance Test | Range 0-30 seconds | Mean | Standard Deviation | seconds |
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| Chair Stands (in 30 seconds) | Mean | Standard Deviation | chair stands |
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| 2-Minute Step Test | Mean | Standard Deviation | steps |
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| Wake after sleep onset | Mean | Standard Deviation | minutes |
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| Total sleep time | Mean | Standard Deviation | Hours |
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| Pittsburgh Sleep Quality Index (PSQI) total score | Range 0-21, higher score indicates lower quality of life. | Mean | Standard Deviation | units on a scale |
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| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) | Range for each subscale 0-100. Higher score indicates higher quality of life. | The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | episodes per day | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | episodes per day | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | episodes per day | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | T-score | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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. | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | seconds | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | chair stands | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | steps | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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. | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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. | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | hours | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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. | Number of participants with outcomes data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
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| Secondary | 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 | Domain is relevant only the sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Repeated change from baseline to 6 and 12 weeks |
|
9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 121 | 1 | 121 | 37 | 121 |
| EG001 | 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. 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. | 0 | 119 | 1 | 119 | 43 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| High Grade B-Cell Lymphoma Burkitt-Like Lymphoma Nos | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Atrial Fibrillation | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Detached Retina | Eye disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Abdominal Cramps | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Dental Discomfort | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Epigastric Pain | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Tooth Pain | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Facial Pain | General disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Allergy Nos | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Hay Fever | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bladder Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Lower Urinary Tract Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Shingles | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Back Sprain | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Knee Injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Lateral Epicondylitis | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Leg Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Pulled Hamstring | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Shoulder Injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Toe Injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
| |
| Vaccination Adverse Reaction | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Colonoscopy | Investigations | MedDRA 22.1 | Non-systematic Assessment |
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| Endoscopy | Investigations | MedDRA 22.1 | Non-systematic Assessment |
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| Back Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Back Pain; Knee Injury | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Foot Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Frozen Shoulder | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Groin Discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Hand Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Hip Arthrosis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Hip Discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Knee Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Knee Swelling | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Leg Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Low Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Lumbar Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Muscle Soreness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Pain Ankle | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Pain In Ankle | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Pain In Elbow | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Pain In Hip | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Patellofemoral Pain Syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Rotator Cuff Injury | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Shoulder Deformity Nos | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Shoulder Soreness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Spinal Disorder Nos | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Melanoma In Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Non-systematic Assessment |
| |
| Cervical Radiculopathy | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Localised Numbness | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Migraine, Unspecified | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Neck Numbness | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Sciatica Aggravated | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Asthma Aggravated | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Asthmatic Attack | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Shortness Of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Cyst Epidermal | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Neck Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Back Surgery | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bladder Sling Procedure | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bunionectomy | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
| |
| Knee Arthroplasty | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
| |
| Oral Surgery | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
| |
| Shoulder Replacement | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
| |
| Hot Flashes | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Huang, MD | University of California, San Francisco | 415-353-7900 | Alison.Huang@ucsf.edu |
| Jul 31, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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| Native Hawaiian or Pacific Islander |
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| American Indian |
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| Other |
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| PISQ-IR Sexually Inactive, Condition Specific Reason for Not Being Active |
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| PISQ-IR Sexually Inactive, Global Quality |
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| PISQ-IR Sexually Inactive, Partner-Related Reasons for Not Being Active |
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| PISQ-IR Sexually Active, Assessment of Arousal, Orgasm |
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| PISQ-IR Sexually Active, Condition-specific Impact on Sexual Quality |
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| PISQ-IR Sexually Active, Condition-specifc Impacts on Activity |
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| PISQ-IR Sexually Active, Assessment of Desire |
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| PISQ-IR Sexually Active, Global Quality |
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| PISQ-IR Sexually Active Interest, Assessment of Partner Related Impacts |
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| PISQ-IR Sexually Active Interest, Summary Score |
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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.
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.
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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.
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.
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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.
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.
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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.
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.
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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.
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.
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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. 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. |
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