Clinical trial NCT01672190: Lessening Incontinence by Learning Yoga
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Urge Urinary Incontinence
Over Active Bladder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of recruiting women with urinary incontinence into a randomized controlled trial of a yoga therapy program.


Eligibility criteria: Inclusion Criteria:

* Women aged 40 years or older who report urinary incontinence for \> 3 months prior to screening
* Self-report at least 7 urinary incontinence episodes per week on a screening 7-day voiding diary
* Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the screening voiding diary
* Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study period
* Capable of understanding study procedures and giving informed consent

Exclusion Criteria:

* Participation in a yoga class or other formal or organized yoga instruction in the past year
* Any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
* Current use of medical therapy or device (i.e. pessary) for incontinence or use within the previous month
* Currently pregnant, gave birth within the past 6 months, or planning pregnancy during the study period
* Current urinary tract infection 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
* Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
* Severe obesity, defined as body mass index \> 35 kg/m2 on screening examination
* Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
* 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 symptomatic pelvic organ prolapse
* 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

Primary outcomes:
measure: Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References: