Clinical trial NCT02342678: Lessening Incontinence Through Low-impact Activity
Official title: Lessening Incontinence Through Low-impact Activity, a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-01-21
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Incontinence Frequency
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Stress-type Incontinence Frequency
timeFrame: Baseline and 3 Months
measure: Urgency-type Incontinence
timeFrame: Baseline and 3 months
measure: Total Daytime Incontinence
timeFrame: Baseline to 3 months
measure: Total Nighttime Incontinence
timeFrame: Baseline to 3 months
measure: Incontinence Impact Questionnaire
timeFrame: Baseline to 3 months
measure: Urogenital Distress Inventory-6
timeFrame: Baseline to 3 months
measure: Patient Perception of Bladder Condition
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alison J Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.