NCT04776720

Ancillary Study of the Lessening Incontinence With Low-impact Activity Study

Ancillary Study of a Randomized Controlled Trial of a Group Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	Yoga Practice Program	3 month group yoga classes
BEHAVIORAL	Physical Conditioning Program	3 month group physical conditioning classes

Timeline

• Start date: 2018-12-19
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2021-03-02
• Last updated: 2023-09-07
• Results posted: 2023-09-07

Locations

1 site across 1 country: United States