A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Status: | Recruiting |
---|---|
Conditions: | Overactive Bladder, Urology, Urology |
Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
Healthy: | No |
Age Range: | 45 - Any |
Updated: | 1/16/2019 |
Start Date: | January 1, 2019 |
End Date: | December 31, 2024 |
Contact: | Alison Huang, MD, MAS, MPhil |
Email: | Alison.Huang@ucsf.edu |
Phone: | 415-514-8697 |
A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a
group-based yoga intervention to decrease the frequency and impact of urinary incontinence in
ambulatory middle-aged and older women and explore potential mediators of improvement in
outcomes. Women aged 50 years and older who report daily or more frequent stress-, urgency-,
or mixed-type incontinence, are not already engaged in formal yoga or muscle
stretching/strengthening programs, are willing to temporarily forgo other clinical treatments
for incontinence, are able to walk to and use the bathroom without assistance, and meet other
eligibility criteria will be recruited from multiple locations surrounding the San Francisco
Bay area.
group-based yoga intervention to decrease the frequency and impact of urinary incontinence in
ambulatory middle-aged and older women and explore potential mediators of improvement in
outcomes. Women aged 50 years and older who report daily or more frequent stress-, urgency-,
or mixed-type incontinence, are not already engaged in formal yoga or muscle
stretching/strengthening programs, are willing to temporarily forgo other clinical treatments
for incontinence, are able to walk to and use the bathroom without assistance, and meet other
eligibility criteria will be recruited from multiple locations surrounding the San Francisco
Bay area.
Inclusion Criteria:
- Women aged 45 years or older who report urinary incontinence starting at least 3
months prior to screening
- Self-report an average of at least one incontinence episode per day on a validated
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:
- Current participation in organized yoga classes or workshops, or any prior organized
yoga training directed specifically at improving incontinence
- Current participation in organized physical conditioning classes involving muscle
strengthening exercises (e.g., Pilates)
- Current urinary tract infection or hematuria detected by urinalysis at screening visit
(women can re-present after evaluation and treatment through their usual care)
- Currently pregnant (by self-report or screening urine pregnancy test), gave birth
within the past 3 months, or planning pregnancy during the study period
- Report use of medical devices (i.e. pessary) for incontinence within the past month
(participants may stop use of device and re-present for study)
- Report use of bladder botox, electrostimulation, formal bladder training, or formal
pelvic floor exercise training (with certified practitioners) in the past 3 months
- Report any history of prior anti-incontinence or urethral surgery (not including
urethral dilation), pelvic cancer, or pelvic irradiation
- Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery,
bladder surgery, colon surgery) within the past 3 months
- Unable to walk 2 blocks on level ground without assistance (functional capacity < 4
metabolic equivalents)
- Unable to get up from a supine to a standing position without assistance (assessed
during the screening visit)
- Report history of interstitial cystitis, bladder or rectal fistula, or congenital
defect causing urinary incontinence
- Report incontinence caused by a major neurologic conditions such as multiple
sclerosis, spinal cord injury, or Parkinson's disease
- Report use of medications with strong effects on urination (anticholinergic bladder
medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics)
within the past month
- Report starting, stopping, or changing the dose of a medication with the potential to
affect anxiety or depression 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
- 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
- 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
We found this trial at
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sites
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San Francisco, California 94143
Principal Investigator: Alison Huang, MD
Phone: 415-885-7547
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