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

NCT ID: NCT04776720

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Yoga Program

The 3-month yoga intervention provides 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.

Group Type: EXPERIMENTAL

Yoga Practice Program

Intervention Type: BEHAVIORAL

3 month group yoga classes

Physical Conditioning Program

The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.

Group Type: ACTIVE_COMPARATOR

Physical Conditioning Program

Intervention Type: BEHAVIORAL

3 month group physical conditioning classes

Interventions

Yoga Practice Program

3 month group yoga classes

Intervention Type: BEHAVIORAL

Physical Conditioning Program

3 month group physical conditioning classes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women aged 45 years or older who report urinary incontinence starting at least 3 months prior to screening
• Self-report an average of at least one incontinence episodes per day voiding diary
• Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary
• Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period

Exclusion Criteria

• Current participation in organized yoga classes or workshops, or any prior organized yoga training directed specifically at improving incontinence
• Current participation in organized physical conditioning classes involving muscle strengthening exercises (e.g., Pilates)
• Current urinary tract infection or hematuria detected by urinalysis at screening visit (women can re-present after evaluation and treatment through their usual care)
• Report use of medical devices (i.e. pessary) for incontinence within the past month (participants may stop use of device and re-present for study)
• Report use of bladder botox, electrostimulation, formal bladder training, or formal pelvic floor exercise training (with certified practitioners) in the past 3 months
• Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation
• Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
• Unable to walk 2 blocks on level ground without assistance (functional capacity < 4 metabolic equivalents)
• Unable to get up from a supine to a standing position without assistance (assessed during the screening visit)
• Report history of interstitial cystitis, bladder or rectal fistula, or congenital defect causing urinary incontinence
• Report incontinence caused by a major neurologic conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease
• Report use of medications with strong effects on urination (anticholinergic bladder medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics) within the past month
• Report starting, stopping, or changing the dose of a medication with the potential to affect anxiety or depression symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period
• Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
• Unable to understand study procedures, complete study interviews, or and provide informed consent in English
• Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Huang, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

1R01DK116712-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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K24AG068601

Identifier Type: NIH

Identifier Source: secondary_id

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K24AG068601

Identifier Type: NIH

Identifier Source: org_study_id

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