Trial Search Results

Lessening Incontinence Through Low-impact Activity

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

University of California, San Francisco

Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Yoga Therapy
  • Behavioral: Physical Conditioning

Phase:

N/A

Eligibility


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

Ages Eligible for Study

50 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham
650-724-7826
Recruiting