Stress Urinary IncontinenceY-PEENCT04298671
Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
A study testing Yoga-Pilates in people with Stress Urinary Incontinence, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a prospective interventional study conducted at Oregon Health \& Science University that will measure the pre- and post-intervention characteristics of women with stress urinary incontinence undergoing an 8-week home yoga-Pilates intervention. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Yoga-Pilates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 31 Jan 2022
- 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 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- >50% episodes of leakage are stress over urge incontinence on a 1-day voiding diary and/OR an answer of "when you are performing some physical activities, such as coughing, sneezing, lifting, or exercise" on the 3-Incontinence Questions (3IQ) Questionnaire
- Access to the Internet and active email address
Who cannot join
- Inability to perform yoga or Pilates due to mobility issues (specifically, inability to get up from chair without assistance or to get up from prone position on floor without assistance)
- Chronic back or neck injury that would prevent yoga or Pilates
- Dementia
- Multiple sclerosis and other neurological disorders such as stroke
- Engaged in yoga, Pilates, or pelvic floor physical therapy in past 6 months
- Current pregnancy or pregnancy in the last 6 months
Show all 14Show fewer
- Untreated urinary tract infection (UTI), unevaluated hematuria, history of >3 diagnosed UTIs in past year
- History of bladder or rectal fistula
- Pelvic cancer or radiation
- Interstitial cystitis or chronic pelvic pain
- Congenital defect leading to urinary incontinence
- Prior anti-incontinence or urethral surgery, prior surgery for pelvic floor disorder
- Current symptomatic pelvic organ prolapse (Stage 2 or greater on exam, i.e. prolapse more than 1cm beyond the hymen)
- Majority of incontinence episodes related to urgency urinary incontinence
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This is a prospective interventional study conducted at Oregon Health \& Science University that will measure the pre- and post-intervention characteristics of women with stress urinary incontinence undergoing an 8-week home yoga-Pilates intervention. The investigators plan to deliver this method of exercise to patients through a web-based video in order to increase accessibility and compliance and decrease patient costs. The investigators will assess changes using a pre- and post-treatment 1-day voiding diary, answers to questionnaires International Consultation on Incontinence Questionnaire-Short Form and Patient Global Impression of Improvement questionnaire), transperineal ultrasound, and physical exam.
Read the detailed description
Stress urinary incontinence (SUI) affects up to 1/3 of women and negatively impacts multiple aspects of a woman's life. Pelvic floor physical therapy has been shown to improve stress incontinence through multiple mechanisms, including rhabdosphincter hypertrophy. Yoga and Pilates have also been shown to improve stress incontinence but there is a key gap in understanding how yoga-Pilates impacts urethral function and if these exercises represent a viable option for treating SUI.
To fill this gap a new exercise is proposed: a web-based 8-week yoga-Pilates pelvic floor workout. The investigators plan to enroll women with SUI and compare urethral rhabdosphincter cross-sectional area in a pre-post intervention study. The investigators will also administer validated quality of life and severity measures for SUI to evaluate the potential efficacy of yoga-Pilates. The overarching goal of this project is to determine how yoga-Pilates impact urethral function and if these exercises decrease SUI symptoms.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Yoga-Pilates
- Keywords
- Yoga, Pilates, Rhabdosphincter
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-PilatesBehavioural
As above
| Study group | Role | What they receive |
|---|---|---|
| Yoga-Pilates Group | Experimental | The 30-minute web-based video exercise program will combine the best yoga-Pilates exercises focused on the pelvic floor, based on prior research and expert opinion, in collaboration with yoga-Pilates instructors that participants will complete 4 times per week for 8 weeks. Receives: Behavioral: Yoga-Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.
The investigators hypothesize that participants will report a minimally important change score difference of -2.5 utilizing the International Consultation on Incontinence Questionnaire-Short Form (range 0-21, lower scores indicate less bother from incontinence).
Measured: 8 weeks
Estimate the effect of an 8-week intervention on urethral rhabdosphincter morphology as measured by transperineal ultrasound.
The investigators hypothesize that this program will cause hypertrophy of the urethral rhabdosphincter with an increase in urethral cross sectional area of 0.25cm2 +/- 0.6cm2.
Measured: 8 weeks
Secondary outcomes (4)
Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention
The investigators hypothesize that the majority of patients will report an answer of at least "a little better" on the PGI-I post-intervention (range 1-7; 1: "very much better", 2: "much better", 3: "a little better", 4: "no change", 5: "a little worse", 6: "much worse", 7: "very much worse")
Measured: 8 weeks
Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.
The investigators hypothesize that the intervention will cause a change in number of incontinence episodes on a 24-hour voiding diary.
Measured: 8 weeks
Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.
The investigators also hypothesize that the levator hiatus area and anteroposterior diameter will change over time due to hypertrophy of the levator muscles.
Measured: 8 weeks
Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.
The investigators hypothesize that the degree of bladder neck descent will change over time with Valsalva.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start13 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/Post
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Cichowski, Oregon Health and Science University
- Investigators
- Sara Cichowski, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298671
- Sponsor's protocol ID
- STUDY00020675
- Acronym
- Y-PEE
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04298671
- Acronym / sponsor ID
- Y-PEE / STUDY00020675
- Conditions
- Stress Urinary Incontinence
- Keywords
- Yoga, Pilates, Rhabdosphincter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- 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.
This is a prospective interventional study conducted at Oregon Health \& Science University that will measure the pre- and post-intervention characteristics of women with stress urinary incontinence undergoing an 8-week home yoga-Pilates intervention. The investigators plan to deliver this method of exercise to patients through a web-based video in order to increase accessibility and compliance and decrease patient costs. The investigators will assess changes using a pre- and post-treatment 1-day voiding diary, answers to questionnaires International Consultation on Incontinence Questionnaire-Short Form and Patient Global Impression of Improvement questionnaire), transperineal ultrasound, and physical exam.
Detailed description
Stress urinary incontinence (SUI) affects up to 1/3 of women and negatively impacts multiple aspects of a woman's life. Pelvic floor physical therapy has been shown to improve stress incontinence through multiple mechanisms, including rhabdosphincter hypertrophy. Yoga and Pilates have also been shown to improve stress incontinence but there is a key gap in understanding how yoga-Pilates impacts urethral function and if these exercises represent a viable option for treating SUI.
To fill this gap a new exercise is proposed: a web-based 8-week yoga-Pilates pelvic floor workout. The investigators plan to enroll women with SUI and compare urethral rhabdosphincter cross-sectional area in a pre-post intervention study. The investigators will also administer validated quality of life and severity measures for SUI to evaluate the potential efficacy of yoga-Pilates. The overarching goal of this project is to determine how yoga-Pilates impact urethral function and if these exercises decrease SUI symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/Post
| Arm | Type | Receives |
|---|---|---|
| Yoga-Pilates Group | Experimental | Behavioral: Yoga-PilatesThe 30-minute web-based video exercise program will combine the best yoga-Pilates exercises focused on the pelvic floor, based on prior research and expert opinion, in collaboration with yoga-Pilates instructors that participants will complete 4 times per week for 8 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- >50% episodes of leakage are stress over urge incontinence on a 1-day voiding diary and/OR an answer of "when you are performing some physical activities, such as coughing, sneezing, lifting, or exercise" on the 3-Incontinence Questions (3IQ) Questionnaire
- Access to the Internet and active email address
Key exclusion criteria (14 listed)
- Inability to perform yoga or Pilates due to mobility issues (specifically, inability to get up from chair without assistance or to get up from prone position on floor without assistance)
- Chronic back or neck injury that would prevent yoga or Pilates
- Dementia
- Multiple sclerosis and other neurological disorders such as stroke
- Engaged in yoga, Pilates, or pelvic floor physical therapy in past 6 months
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-PilatesAs above | Behavioural | Yoga-Pilates Group |
Primary outcome
Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.
Time frame: 8 weeks
The investigators hypothesize that participants will report a minimally important change score difference of -2.5 utilizing the International Consultation on Incontinence Questionnaire-Short Form (range 0-21, lower scores indicate less bother from incontinence).
Estimate the effect of an 8-week intervention on urethral rhabdosphincter morphology as measured by transperineal ultrasound.
Time frame: 8 weeks
The investigators hypothesize that this program will cause hypertrophy of the urethral rhabdosphincter with an increase in urethral cross sectional area of 0.25cm2 +/- 0.6cm2.
4 secondary outcomes
Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention
Time frame: 8 weeks
Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.
Time frame: 8 weeks
Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.
Time frame: 8 weeks
Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.
Time frame: 8 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 14 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Sara Cichowski, MD principal investigator
Oregon Health and Science University
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-Pilates in people with Stress Urinary Incontinence, run by Oregon Health and Science University 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 3 inclusion and 14 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 14 Jul 2022. 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?
Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention. (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 14 Jul 2022.