Stress Urinary IncontinenceNCT03118557
Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence
A study testing Pilates pelvic floor strengthening in people with Stress Urinary Incontinence, run by Mayo Clinic at 1 site in United States.
Trial summary
Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age? Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pilates pelvic floor strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 11 Dec 2017
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-70 years of age.
- Able to provide informed consent.
- Able to lower and rise from the floor safely and independently.
- Anticipated to be able to attend at least 9 of the first 12 classes (75%) in weeks 1-6.
- Anticipated to be able to attend at least 9 of the final 12 classes (75%) in weeks 7-12.
- Score of 6+ on ICIQ-UI Short Form.
Who cannot join
- Pregnancy
- Unable to speak and comprehend English
- Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: HLP-16-003H: Does a Twice Weekly, 12-week Pilates Pelvic Floor Strengthening Program Improve Short- and Long-term Measures of Stress Urinary Incontinence Symptoms in Women Ages 45-70 Years of Age.
Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pilates pelvic floor strengthening
- Keywords
- pelvic floor, strengthening, Stress, urinary, incontinence
- 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.
Pilates pelvic floor strengtheningOther
Pilates pelvic floor strengthening.
| Study group | Role | What they receive |
|---|---|---|
| Pilates pelvic floor strengthening exercise | Experimental | Not described Receives: Other: Pilates pelvic floor strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on International Consultation on Incontinence (ICIQ-UI Short Form)
The ICIQ-UI Short Form consists of 3 questions. The ICIQ score is a sum of the responses to the 3 questions with a total possible range of 0 (none) to 21 (all the time/a great deal).
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire
The MESA Urinary Incontinence Questionnaire consists of 3 sections: General questions (unscored), Urge Incontinence (6 questions), and Stress Incontinence (9 questions). The scored questions can range from 0 (never) to 3 (often). The score for the Urge Incontinence is the sum of the responses/18, and the score for the Stress Incontinence section is the sum of the responses/27.
Measured: Baseline, 12 weeks
Change in score on Linear Analogue Self Assessment (LASA)
The LASA questionnaire consists of 6 questions, each ranging from 0 (as bad as it can be) to 10 (as good as it can be). Therefore, the total possible scores would range from 0 (as bad as it can be) to 60 (as good as it can be).
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start19 Apr 2017
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
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 Mayo ClinicThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Rhodes, Mayo Clinic
- Investigators
- Deborah J Rhodes, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118557
- Sponsor's protocol ID
- 17-001061
- Status last verified
- Mar 2019
- First submitted
- 13 Apr 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLP-16-003H: Does a Twice Weekly, 12-week Pilates Pelvic Floor Strengthening Program Improve Short- and Long-term Measures of Stress Urinary Incontinence Symptoms in Women Ages 45-70 Years of Age.
- ClinicalTrials.gov ID
- NCT03118557
- Acronym / sponsor ID
- 17-001061
- Conditions
- Stress Urinary Incontinence
- Keywords
- pelvic floor, strengthening, Stress, urinary, incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 18 Apr 2017 (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.
Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilates pelvic floor strengthening exercise | Experimental | Other: Pilates pelvic floor strengthening |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 45-70 years of age.
- Able to provide informed consent.
- Able to lower and rise from the floor safely and independently.
- Anticipated to be able to attend at least 9 of the first 12 classes (75%) in weeks 1-6.
- Anticipated to be able to attend at least 9 of the final 12 classes (75%) in weeks 7-12.
Key exclusion criteria (3 listed)
- Pregnancy
- Unable to speak and comprehend English
- Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.
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 |
|---|---|---|
| Pilates pelvic floor strengtheningPilates pelvic floor strengthening. | Other | Pilates pelvic floor strengthening exercise |
Primary outcome
Change in score on International Consultation on Incontinence (ICIQ-UI Short Form)
Time frame: Baseline, 12 weeks
The ICIQ-UI Short Form consists of 3 questions. The ICIQ score is a sum of the responses to the 3 questions with a total possible range of 0 (none) to 21 (all the time/a great deal).
2 secondary outcomes
Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire
Time frame: Baseline, 12 weeks
Change in score on Linear Analogue Self Assessment (LASA)
Time frame: Baseline, 12 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 25 Mar 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Deborah J Rhodes principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates pelvic floor strengthening in people with Stress Urinary Incontinence, run by Mayo Clinic 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 6 inclusion and 3 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 25 Mar 2019. 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 score on International Consultation on Incontinence (ICIQ-UI Short Form) (time frame: Baseline, 12 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 25 Mar 2019; AzTrials last refreshed its copy on 31 Oct 2026.