Lessening Incontinence Through Low-impact Activity (LILA)

Lessening Incontinence Through Low-impact Activity, a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Behavioral: Yoga Therapy; Behavioral: Physical Conditioning

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Report symptomatic pelvic organ prolapse (assessed using a standardized question, ""Have your pelvic organs (uterus, bladder, or rectum) been dropping out of your vagina causing a feeling of bulging, pressure, or protrusion or a sensation like your "insides are coming out"?")
• Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Therapy Group; 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
Experimental: Physical Conditioning Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress-type Incontinence Frequency	Change in the frequency of stress-type incontinence episodes 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
Urgency-type Incontinence	Change in frequency of urgency-type incontinence 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
Total Daytime Incontinence	Change in frequency of total daytime incontinence 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 to 3 months
Total Nighttime Incontinence	Change in frequency of total nighttime incontinence 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 to 3 months
Incontinence Impact Questionnaire	Change in questionnaire score for Incontinence Impact Questionnaire. Range 0-400, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes 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 to 3 months
Urogenital Distress Inventory-6	Change in the questionnaire score for Urogenital Distress Inventory-6. Range 0-100, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes 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 to 3 months
Patient Perception of Bladder Condition	Change in questionnaire score for Patient Perception of Bladder Condition. Range 1-6, with higher score mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes 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 to 3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Alison J Huang, MD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 14-14732; 1R34AT008028-01A1 (U.S. NIH Grant/Contract)