Stress Incontinence, FemaleNCT03672461
A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
A study testing Yoga Practice Program and Physical Conditioning Program in people with Stress Incontinence, Female and Stress Incontinence, Urinary, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Incontinence, Female, Stress Incontinence, Urinary, Stress Incontinence
- What is being tested?
- Yoga Practice Program and Physical Conditioning Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University
Palo Alto, California, 94305
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women and explore potential mediators of improvement in outcomes. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria will be recruited from multiple locations surrounding the San Francisco Bay area.
- Conditions
- Stress Incontinence, Female, Stress Incontinence, Urinary, Stress Incontinence, Urge Incontinence, Urinary Incontinence, Stress, Urinary Stress Incontinence
- Being tested
- Yoga Practice Program, Physical Conditioning Program
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Practice ProgramOther
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Yoga Practice Program |
| 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. Receives: Other: Physical Conditioning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Repeated change from baseline to 6 and 12 weeks
Secondary outcomes (27)
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
Measured: Repeated change from baseline to 6 and 12 weeks
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Repeated change from baseline to 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start6 Mar 2019
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Incontinence, FemaleStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
- Responsible party
- Sponsor
- Investigators
- Alison Huang, MS, MAS, MPhil, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672461
- Sponsor's protocol ID
- P0529491
- Other IDs
- R01DK116712-01A1
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2018
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42348866Hough 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.
PubMed 41359336Huang 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.
PubMed 39186785Huang 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.
PubMed 35167358
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
- ClinicalTrials.gov ID
- NCT03672461
- Acronym / sponsor ID
- P0529491
- Conditions
- Stress Incontinence, Female, Stress Incontinence, Urinary, Stress Incontinence, Urge Incontinence, Urinary Incontinence, Stress, Urinary Stress Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 3 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Practice Program | Experimental | Other: Yoga Practice ProgramThe 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. |
| Physical Conditioning Program | Active comparator | Other: Physical Conditioning ProgramThe 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Practice ProgramThe 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. | Other | Yoga Practice Program |
| Physical Conditioning ProgramThe 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. | Other | Physical Conditioning Program |
Primary outcome
Change From Baseline in Total Urinary Incontinence Episodes
Time frame: Repeated change from baseline to 6 and 12 weeks
Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points.
27 secondary outcomes
Change From Baseline in Stress-Type Urinary Incontinence Episodes
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Urgency-Type Urinary Incontinence Episodes
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Incontinence Impact Questionnaire (IIQ)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Perceived Stress Scale (PSS) Score
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in One-legged Balance Test (Winsorized)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Chair Stands (in 30 Seconds)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in 2-Minute Step Test
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Wake After Sleep Onset (Winsorized)
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Total Sleep Time
Time frame: Repeated change from baseline to 6 and 12 weeks
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Repeated change from baseline to 6 and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42348866Yang 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.
- Derived from this study: PubMed 41359336Hough 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.
- Derived from this study: PubMed 39186785Huang 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.
- Derived from this study: PubMed 35167358Huang 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.
- Individual participant dataSharing planned: No
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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Huang, MS, MAS, MPhil principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Practice Program and Physical Conditioning Program in people with Stress Incontinence, Female and Stress Incontinence, Urinary, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Urinary Incontinence Episodes (time frame: Repeated change from baseline to 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672461, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.