Lessening Incontinence Through Low-impact Activity



Status:Completed
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:50 - Any
Updated:12/21/2018
Start Date:January 2015
End Date:April 2017

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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.


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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Alison Huang, MD
Phone: 415-885-7547
?
mi
from
San Francisco, CA
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