45 and older, female only, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in One-legged Balance Test (Winsorized)Primary· Repeated change from baseline to 6 and 12 weeks
Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance.
Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percen
Group
Value
95% CI
Yoga Program
1.34
0.52 – 2.16
Physical Conditioning Program
1.53
0.72 – 2.35
Change From Baseline in Chair Stands (in 30 Seconds)Primary· Repeated change from baseline to 6 and 12 weeks
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.
Higher score indicates better quality of life
Group
Value
95% CI
Yoga Program
1
0.32 – 1.68
Physical Conditioning Program
1.98
1.3 – 2.66
Change From Baseline in 2-Minute Step TestPrimary· Repeated change from baseline to 6 and 12 weeks
Assess change in aerobic endurance. In this test of aerobic endurance for older adults, participants are asked to step in place as many times as possible in a 2 minute period, each time raising the knee to a level midway between the patella and iliac crest.
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 scores indicating greater endurance.
Group
Value
95% CI
Yoga Program
8.05
4.58 – 11.51
Physical Conditioning Program
9.03
5.59 – 12.48
Change From Baseline in Perceived Stress Scale (PSS) ScoreSecondary· Repeated change from baseline to 6 and 12 weeks
Assess change in total score on Perceived Stress Scale (PSS), a 10-item measure of thoughts and feelings related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40; higher scores indicated greater perceived stress.
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
Group
Value
95% CI
Yoga Program
-0.44
-1.41 – 0.52
Physical Conditioning Program
-0.72
-1.68 – 0.24
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)Secondary· Repeated change from baseline to 6 and 12 weeks
Assess change in total score on Center for Epidemiologic Studies Depression (CES-D) scale, a validated 20-item self-administered questionnaire measure that has been widely used in clinical trials, including trials of bladder interventions, and has been shown to be sensitive to change. Total scores range from 0 to 60, with higher scores indicate greater burden of depression symptoms.
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
Group
Value
95% CI
Yoga Program
-0.82
-2.25 – 0.6
Physical Conditioning Program
-0.52
-1.93 – 0.9
Change From Baseline in State/Trait Anxiety Inventory (STAI)--TraitSecondary· Repeated change from baseline to 6 and 12 weeks
Assess change in somatic anxiety. Somatic anxiety (i.e., the affective component of anxiety believed to be related to autonomic physiological arousal response) is measured using the trait component of the Spielberger State Trait Anxiety Inventory (STAI), a 20-item self-administered measure validated in clinical populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.
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
Group
Value
95% CI
Yoga Program
-1.22
-2.41 – -0.03
Physical Conditioning Program
-1.34
-2.52 – -0.17
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety ScoreSecondary· Repeated change from baseline to 6 and 12 weeks
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range 0-21, Higher score indicates lower quality of life
Group
Value
95% CI
Yoga Program
-0.21
-0.72 – 0.3
Physical Conditioning Program
-0.33
-0.83 – 0.18
Change From Baseline in Wake After Sleep Onset (Winsorized)Secondary· Repeated change from baseline to 6 and 12 weeks
Assess change in sleep disruption. Average time spent awake after initial sleep onset is also assessed using the Pittsburgh Sleep Diary, based on participant recordings of nocturnal awakenings after initially falling asleep.
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 lower quality of life.
Group
Value
95% CI
Yoga Program
-3.55
-7.96 – 0.85
Physical Conditioning Program
-6.96
-11.3 – -2.61
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total ScoreSecondary· Repeated change from baseline to 6 and 12 weeks
Assess change in global sleep quality. Subjective sleep quality is being assessed using the Pittsburgh Sleep Quality Index (PSQI), an 18-item validated questionnaire originally designed to assess sleep quality, latency, efficiency, and problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep 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
Group
Value
95% CI
Yoga Program
-0.37
-0.78 – 0.04
Physical Conditioning Program
-0.66
-1.07 – -0.25
Change From Baseline in Total Sleep TimeSecondary· Repeated change from baseline to 6 and 12 weeks
Assess change in average nightly sleep duration. Average total sleep duration is assessed using the Pittsburgh Sleep Diary is a daily self-report measure previously validated against actigraphy data, and used in multiple past studies of older adults.
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.
Group
Value
95% CI
Yoga Program
0
-0.18 – 0.17
Physical Conditioning Program
0.09
-0.08 – 0.27
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Yoga Program
Serious: 1/121 (1%)
Deaths: 0/121
Physical Conditioning Program
Serious: 1/119 (1%)
Deaths: 0/119
Serious adverse events (2 terms)
Reaction
System
Yoga Program
Physical Conditioning Prog…
Atrial Fibrillation
Cardiac disorders
—
—
High Grade B-Cell Lymphoma Burkitt-Like Lymphoma Nos
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The parent trial that supports this ancillary research is 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.
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 are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N\~120) or a time-equivalent, non-specific muscle stretching and strengthening control program (N\~120).
During the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props.
For this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/severity/impact, examine intervention effects on these ancillary outcomes, and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequency/severity/impact.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03672461 — A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 7 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04776720.