Urinary IncontinenceNCT03869918
Physical Exercise and Bladder Training Program for Urinary Incontinence
A study testing Exercise Program in people with Urinary Incontinence, run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall objective of this project is to reduce the risk of falls in elderly community dwelling women over 60 years of age with urgency urinary incontinence (UUI). In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention (bladder… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2014to 1 Sep 2018
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- age 60+ years
- community dwelling
- Moderate to severe UUI (as measured by International Consultation on Incontinence Questionnaire Short Form)
- low physical activity (Physical Activity Staging questionnaire)
- cognitively able to complete the study (in opinion of the referring provider) Women currently on anti-cholinergic medication for urinary incontinence will be allowed if particpants meet the above criteria.
Who cannot join
- cognitive impairment (in opinion of the referring provider)
- unable to provide informed consent or communicate in English
- desire for surgical management
- osteoporosis
- lack of medical clearance from the physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparative Effectiveness of Integrated Exercise and Urge Suppression Verses Usual Care for Reducing the Risk of Falls in Women With Urgency Urinary Incontinence
The overall objective of this project is to reduce the risk of falls in elderly community dwelling women over 60 years of age with urgency urinary incontinence (UUI). In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention (bladder training) that targets functional mobility, reduces anxiety urgency and physical barriers and is implemented in partnership with all stakeholders. Key eligibility criteria: women over 60 years of age, with moderate to severe UUI, and low physical activity.
Read the detailed description
Over 40% women age 65 and older or an estimated million women in the US suffer from urgency urinary incontinence (UUI), a condition characterized by urgency to urinate. UUI is a well-known marker for frailty and older women with UUI are at two fold higher risk for falls. According to the biopsycho- ecological paradigm, UUI and its associated falls are the result of interaction of the patients physical abilities (bladder urgency and reduced balance and strength to reach the toilet), mental attitudes (anxiety related to urgency, shame and stigma of leakage), social expectations (life demand and roles that limit access to bathroom), and physical environment (physical barriers to reach the toilet).
Anti-muscarinic medications, the most common treatment for UUI, address only bladder urgency and their side-effects may exacerbate falls. The investigators plan an innovative treatment approach that will integrate each of the bio-psycho-ecological levels implicated in UUI and falls. Strength and balance exercises improve functional mobility and have been shown to reduce both fall risk as well as UUI in high risk frail older adults. Behavioral urge suppression reduces anxiety related to urgency and improves mental abilities to handle life demands and roles. Simple home improvements can reduce environmental barriers. Adherence is an important barrier in the implementation of exercise and behavior modification. Prior studies, including those by the investigators, have shown that preferred treatments are associated with improved adherence, satisfaction and outcomes in women with UUI. The investigators hypothesize that an integrated exercise and urge suppression program targeted to improving physical performance relevant to continence behavior will reduce the risk of falls in appropriately selected community dwelling women with urinary incontinence. In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention that targets functional mobility, reduces anxiety urgency and physical barriers and is implemented in partnership with all stakeholders. The proposed pilot study for a planned submission in June 2014 fulfills PCORIs national priorities and research agenda through improving patient centered outcome measures, informed decision making based on risks and benefits, innovative Page 9 of 17 community based delivery of the intervention, addressing barriers to care, and engaging all stakeholders involved in the care of older women with UUI including patients, providers, and community advocates.
The overall objective of this project is to reduce the risk of falls in elderly frail community dwelling women with urgency urinary incontinence (UUI). The specific aim is: To determine the feasibility of enrollment and randomization of a comparative effectiveness trial of integrated exercise and urge suppression program versus usual care in older community dwelling women with urge urinary incontinence. Hypothesis: Older women with UUI who receive their preferred treatment option, exercises and urge suppression, will have better objective (fewer functional limitations, falls risk and urinary incontinence) and subjective (HRQOL, satisfaction with care, and psychological wellbeing) outcomes than women who receive usual care.
- Conditions
- Urinary Incontinence
- Being tested
- Exercise Program
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
Exercise at home or through a class as chosen by the subject.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participant is assigned to undergo standard of care. |
| Exercise Group | Experimental | If the participant is assigned to the exercise group, she will either exercise at home or take a class at the participating facility under the supervision of an instructor. Receives: Other: Exercise Program |
| Observational Group | No intervention | If a subject is eligible, but does not want to exercise, she will be in a third group that is an observation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function as measured by the Short Physical Performance Battery
An objective measure of physical function as measured by the Short Physical Performance Battery that measures balance, gait speed, and lower extremity strength and has high validity and sensitivity to change for predicting fall risk.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start30 Mar 2014
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
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 PennsylvaniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized comparative effectiveness trial of integrated exercise and urge suppression versus usual care in older women with UUI.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869918
- Sponsor's protocol ID
- 819469
- Status last verified
- Feb 2020
- First submitted
- 8 Mar 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Integrated Exercise and Urge Suppression Verses Usual Care for Reducing the Risk of Falls in Women With Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03869918
- Acronym / sponsor ID
- 819469
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Mar 2014 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 11 Mar 2019 (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.
The overall objective of this project is to reduce the risk of falls in elderly community dwelling women over 60 years of age with urgency urinary incontinence (UUI). In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention (bladder training) that targets functional mobility, reduces anxiety urgency and physical barriers and is implemented in partnership with all stakeholders. Key eligibility criteria: women over 60 years of age, with moderate to severe UUI, and low physical activity.
Detailed description
Over 40% women age 65 and older or an estimated million women in the US suffer from urgency urinary incontinence (UUI), a condition characterized by urgency to urinate. UUI is a well-known marker for frailty and older women with UUI are at two fold higher risk for falls. According to the biopsycho- ecological paradigm, UUI and its associated falls are the result of interaction of the patients physical abilities (bladder urgency and reduced balance and strength to reach the toilet), mental attitudes (anxiety related to urgency, shame and stigma of leakage), social expectations (life demand and roles that limit access to bathroom), and physical environment (physical barriers to reach the toilet).
Anti-muscarinic medications, the most common treatment for UUI, address only bladder urgency and their side-effects may exacerbate falls. The investigators plan an innovative treatment approach that will integrate each of the bio-psycho-ecological levels implicated in UUI and falls. Strength and balance exercises improve functional mobility and have been shown to reduce both fall risk as well as UUI in high risk frail older adults. Behavioral urge suppression reduces anxiety related to urgency and improves mental abilities to handle life demands and roles. Simple home improvements can reduce environmental barriers. Adherence is an important barrier in the implementation of exercise and behavior modification. Prior studies, including those by the investigators, have shown that preferred treatments are associated with improved adherence, satisfaction and outcomes in women with UUI. The investigators hypothesize that an integrated exercise and urge suppression program targeted to improving physical performance relevant to continence behavior will reduce the risk of falls in appropriately selected community dwelling women with urinary incontinence. In this pilot study, the investigators plan to develop, validate and test a home based integrated exercise and urge suppression intervention that targets functional mobility, reduces anxiety urgency and physical barriers and is implemented in partnership with all stakeholders. The proposed pilot study for a planned submission in June 2014 fulfills PCORIs national priorities and research agenda through improving patient centered outcome measures, informed decision making based on risks and benefits, innovative Page 9 of 17 community based delivery of the intervention, addressing barriers to care, and engaging all stakeholders involved in the care of older women with UUI including patients, providers, and community advocates.
The overall objective of this project is to reduce the risk of falls in elderly frail community dwelling women with urgency urinary incontinence (UUI). The specific aim is: To determine the feasibility of enrollment and randomization of a comparative effectiveness trial of integrated exercise and urge suppression program versus usual care in older community dwelling women with urge urinary incontinence. Hypothesis: Older women with UUI who receive their preferred treatment option, exercises and urge suppression, will have better objective (fewer functional limitations, falls risk and urinary incontinence) and subjective (HRQOL, satisfaction with care, and psychological wellbeing) outcomes than women who receive usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A pilot randomized comparative effectiveness trial of integrated exercise and urge suppression versus usual care in older women with UUI.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participant is assigned to undergo standard of care. |
| Exercise Group | Experimental | Other: Exercise ProgramIf the participant is assigned to the exercise group, she will either exercise at home or take a class at the participating facility under the supervision of an instructor. |
| Observational Group | No intervention | –If a subject is eligible, but does not want to exercise, she will be in a third group that is an observation group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female
- age 60+ years
- community dwelling
- Moderate to severe UUI (as measured by International Consultation on Incontinence Questionnaire Short Form)
- low physical activity (Physical Activity Staging questionnaire)
Key exclusion criteria (5 listed)
- cognitive impairment (in opinion of the referring provider)
- unable to provide informed consent or communicate in English
- desire for surgical management
- osteoporosis
- lack of medical clearance from the physician.
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 |
|---|---|---|
| Exercise ProgramExercise at home or through a class as chosen by the subject. | Other | Exercise Group |
Primary outcome
Physical Function as measured by the Short Physical Performance Battery
Time frame: 2 months
An objective measure of physical function as measured by the Short Physical Performance Battery that measures balance, gait speed, and lower extremity strength and has high validity and sensitivity to change for predicting fall risk.
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 5 Feb 2020.
- 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.
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 Exercise Program in people with Urinary Incontinence, run by University of Pennsylvania 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 5 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 5 Feb 2020. 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?
Physical Function as measured by the Short Physical Performance Battery (time frame: 2 months). 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 5 Feb 2020.