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

NCT03672461 | Completed Results DMC

• 2 other identifiers: P0529491R01DK116712-01A1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Urinary Incontinence Episodes

  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.

  Repeated change from baseline to 6 and 12 weeks

Secondary Outcomes (27)

• Change From Baseline in Stress-Type Urinary Incontinence Episodes

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Urgency-Type Urinary Incontinence Episodes

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Incontinence Impact Questionnaire (IIQ)

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)

  Repeated change from baseline to 6 and 12 weeks

• Change From Baseline in Patient Perception of Bladder Condition (PPBC)

  Repeated change from baseline to 6 and 12 weeks

Study Arms (2)

Yoga Practice Program

EXPERIMENTAL

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.

Other: Yoga Practice Program

Physical Conditioning Program

ACTIVE COMPARATOR

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.

Other: Physical Conditioning Program

Interventions

Yoga Practice Program 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.

Yoga Practice Program

Physical Conditioning Program 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.

Physical Conditioning Program

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• 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 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

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)
• 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

Sponsors & Collaborators

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

Study Sites (2)

Stanford University

Palo Alto, California, 94305, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (3)

• 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

• 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.

  PMID: 39186785 DERIVED

• 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.

  PMID: 35167358 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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
• Organization: University of California, San Francisco

Alison.Huang@ucsf.edu

415-353-7900

Study Officials

• Alison Huang, MS, MAS, MPhil

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 13, 2018
• First Posted: September 14, 2018
• Study Start: March 6, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 30, 2025
• Results First Posted: October 3, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)