Lessening Incontinence Through Low-impact Activity

NCT02342678 | Completed Results DMC

• 2 other identifiers: 14-147321R34AT008028-01A1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy program versus physical conditionin control program for treatment of urinary incontinence in ambulatory middle-aged and older women. Women aged 50 years and older who meet the criteria for frequency of incontinence episodes, are not using other clinical treatments for incontinence, and meet minimum physical mobility requirements and other eligibility criteria will be recruited from the general San Francisco Bay Area.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Total Incontinence Frequency

  Change in the frequency of urinary incontinence episodes of any type. Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.

  Baseline and 3 months

Secondary Outcomes (7)

• Stress-type Incontinence Frequency

  Baseline and 3 Months

• Urgency-type Incontinence

  Baseline and 3 months

• Total Daytime Incontinence

  Baseline to 3 months

• Total Nighttime Incontinence

  Baseline to 3 months

• Incontinence Impact Questionnaire

  Baseline to 3 months

Study Arms (2)

Yoga Therapy Group

EXPERIMENTAL

Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.

Behavioral: Yoga Therapy

Physical Conditioning Group

EXPERIMENTAL

Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.

Behavioral: Physical Conditioning

Interventions

Yoga Therapy BEHAVIORAL

Yoga Therapy Group

Physical Conditioning BEHAVIORAL

Physical Conditioning Group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50 years or older who report urinary incontinence starting at least 3 months prior to screening
• Self-report at least required frequency of urinary incontinence episodes on a screening 3-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:

• Participation in formal or organized yoga classes or instruction within the past 3 months; or any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
• Participation in at least weekly organized physical conditioning classes or instruction in the past 3 months involving muscle stretching and strengthening exercises (not including aerobic classes that do not emphasize stretching or strengthening).
• Currently pregnant (by self-report or screening urine pregnancy test), gave birth within the past 6 months, or planning pregnancy during the study period (approximately 2 to 6 months)
• Current urinary tract infection (screening dipstick urinalysis with leukocyte estrace, nitrites or blood) or a history or 3 or more urinary tract infections in the preceding year
• Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms
• Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance (i.e., functional capacity \< 4 METs)
• Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
• Morbid obesity defined by a measured body mass index of \>40 kg/m2 at the screening evaluation.
• Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason
• Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
• Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
• Report use of medications with the potential to affect incontinence (anticholinergic bladder medications, tricyclic antidepressants, selective norepinephrine reuptake inhibitors, mirabegron, loop diuretics) within the past month
• Report starting stopping, or changing the dose of a medication with the potential to affect anxiety or stress 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
• Report use of medical devices (i.e. pessary) for incontinence within the previous month (participants may stop use of device and re-present for study)
• Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (2)

• Nicosia FM, Lisha NE, Chesney MA, Subak LL, Plaut TM, Huang A. Strategies for evaluating self-efficacy and observed success in the practice of yoga postures for therapeutic indications: methods from a yoga intervention for urinary incontinence among middle-aged and older women. BMC Complement Med Ther. 2020 May 14;20(1):148. doi: 10.1186/s12906-020-02934-3.

  PMID: 32408868 DERIVED

• Huang AJ, Chesney M, Lisha N, Vittinghoff E, Schembri M, Pawlowsky S, Hsu A, Subak L. A group-based yoga program for urinary incontinence in ambulatory women: feasibility, tolerability, and change in incontinence frequency over 3 months in a single-center randomized trial. Am J Obstet Gynecol. 2019 Jan;220(1):87.e1-87.e13. doi: 10.1016/j.ajog.2018.10.031. Epub 2018 Oct 26.

  PMID: 30595143 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Yoga; Exercise Therapy

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Results Point of Contact

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

alison.huang@ucsf.edu

415-514-8697

Study Officials

• Alison J Huang, MD

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 19, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-11

Locations

US (1)