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

NCT04776720 | Completed Results DMC

• 2 other identifiers: K24AG0686011R01DK116712-01A1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in One-legged Balance Test (Winsorized)

  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 percentile. 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 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

  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.

  Repeated change from baseline to 6 and 12 weeks

Secondary Outcomes (7)

• Change From Baseline in Perceived Stress Scale (PSS) Score

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Wake After Sleep Onset (Winsorized)

  Repeated change from baseline to 6 and 12 weeks

Study Arms (2)

Yoga Program

EXPERIMENTAL

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.

Behavioral: Yoga Practice Program

Physical Conditioning Program

ACTIVE COMPARATOR

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.

Behavioral: Physical Conditioning Program

Interventions

Yoga Practice Program BEHAVIORAL

3 month group yoga classes

Yoga Program

Physical Conditioning Program BEHAVIORAL

3 month group physical conditioning classes

Physical Conditioning Program

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 41359336 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alison Huang, MD, MAS, MPhil
• Organization: University of California, San Francisco

alison.huang@ucsf.edu

415-353-7900

Study Officials

• Alison Huang, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: December 19, 2018
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)