Urinary IncontinenceLILYNCT01672190
Lessening Incontinence by Learning Yoga
A study testing Yoga Therapy Program in people with Urinary Incontinence and Stress Urinary Incontinence, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Incontinence
- What is being tested?
- Yoga Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
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.
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Incontinence, Over Active Bladder
- Being tested
- Yoga Therapy Program
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Therapy ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| Yoga Therapy | Experimental | Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks. Receives: Other: Yoga Therapy Program |
| Control | No intervention | Women in the Control Group will wait 6 weeks before receiving a gift certificate for yoga classes at an external yoga studio in the San Francisco Bay Area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Huang, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672190
- Sponsor's protocol ID
- 12-09389
- Acronym
- LILY
- Status last verified
- Jan 2013
- First submitted
- 16 Aug 2012
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lessening Incontinence by Learning Yoga
- ClinicalTrials.gov ID
- NCT01672190
- Acronym / sponsor ID
- LILY / 12-09389
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Incontinence, Over Active Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Therapy | Experimental | Other: Yoga Therapy ProgramWomen in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks. |
| Control | No intervention | –Women in the Control Group will wait 6 weeks before receiving a gift certificate for yoga classes at an external yoga studio in the San Francisco Bay Area |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Therapy Program | Other | Yoga Therapy |
Primary outcome
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Therapy Program in people with Urinary Incontinence and Stress Urinary Incontinence, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.