A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

NCT ID: NCT03672461

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2022-12-31

Brief 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. 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; Urgency Urinary

Study Design

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

Study Groups

Yoga Practice Program

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.

Group Type: EXPERIMENTAL

Yoga Practice Program

Intervention Type: OTHER

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 Program

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.

Group Type: ACTIVE_COMPARATOR

Physical Conditioning Program

Intervention Type: OTHER

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.

Interventions

Yoga Practice Program

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.

Intervention Type: OTHER

Physical Conditioning Program

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.

Intervention Type: OTHER

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 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

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)
• 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
• 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

Stanford University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Huang, MS, MAS, MPhil

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Stanford University

Palo Alto, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Huang 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.

Reference Type: DERIVED

PMID: 39186785 (View on PubMed)

Huang 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.

Reference Type: DERIVED

PMID: 35167358 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK116712-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0529491

Identifier Type: -

Identifier Source: org_study_id