Urinary IncontinenceLILANCT02342678
Lessening Incontinence Through Low-impact Activity
A study testing Yoga Therapy and Physical Conditioning in people with Urinary Incontinence, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Yoga Therapy and Physical Conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: 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.
- Conditions
- Urinary Incontinence
- Being tested
- Yoga Therapy, Physical Conditioning
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TherapyBehavioural
Physical ConditioningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Alison J Huang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342678
- Sponsor's protocol ID
- 14-14732
- Other IDs
- 1R34AT008028-01A1
- Acronym
- LILA
- Status last verified
- Nov 2018
- First submitted
- 15 Jan 2015
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 32408868Huang 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.
PubMed 30595143
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lessening Incontinence Through Low-impact Activity, a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT02342678
- Acronym / sponsor ID
- LILA / 14-14732
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Therapy Group | Experimental | Behavioral: Yoga TherapyParticipants 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. |
| Physical Conditioning Group | Experimental | Behavioral: Physical ConditioningPatricipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Therapy | Behavioural | Yoga Therapy Group |
| Physical Conditioning | Behavioural | Physical Conditioning Group |
Primary outcome
Total Incontinence Frequency
Time frame: Baseline and 3 months
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.
7 secondary outcomes
Stress-type Incontinence Frequency
Time frame: Baseline and 3 Months
Urgency-type Incontinence
Time frame: Baseline and 3 months
Total Daytime Incontinence
Time frame: Baseline to 3 months
Total Nighttime Incontinence
Time frame: Baseline to 3 months
Incontinence Impact Questionnaire
Time frame: Baseline to 3 months
Urogenital Distress Inventory-6
Time frame: Baseline to 3 months
Patient Perception of Bladder Condition
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32408868Nicosia 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.
- Derived from this study: PubMed 30595143Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison J Huang, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Therapy and Physical Conditioning in people with Urinary Incontinence, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Incontinence Frequency (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342678, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.