Urinary Incontinence, UrgeSHUWNCT03176901
Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial
A study testing Mindfulness-Based Stress Reduction and Health Enhancement Program in people with Urinary Incontinence, Urge and Urinary Incontinence in Old Age, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on… Read more about this study
- Who is it for?
- Ages 55 to 105 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urge, Urinary Incontinence in Old Age
- What is being tested?
- Mindfulness-Based Stress Reduction and Health Enhancement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to 12 Apr 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 55 to 105 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The following eligibility criteria must be met for the potential participant to be considered for enrollment.
- The study is enrolling older adult women, with urinary urge incontinence.
- They cannot be currently treating their urinary urge incontinence with medication as this will confound results.
- Women who have attempted more extreme treatments and are still experiencing urinary urge incontinence will not be considered as potential participants, as it is unlikely that mindfulness-based stress reduction would treat urinary urge incontinence that is refractory to that degree.
- Participants must be English speaking, as the interventions and homework will be delivered in English.
- postmenopausal women
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- Urge predominant urinary incontinence, defined as score of ≥ 3 (moderate to severe urinary incontinence) on the Incontinence Severity Index
- Urge predominant urinary incontinence as determined by question 3 on the 3 Incontinence Questions. The 3 Incontinence Questions has been shown to be a quick and accurate way of diagnosing stress, urge or mixed incontinence in most cases
- Has experienced urinary urge incontinence symptoms for at least three months
- Committed to attend 8 weekly sessions and one half day retreat between weeks 6 and 7
- No pharmacologic therapy for urinary urge incontinence within three weeks of enrollment and no plan to initiate such medications during the 8 week active treatment
- If on hormone therapy or vaginal estrogen, plan to remain on it for the duration of the study; if not on it, no plan to initiate
- No previous intradetrusor Botox injection for urinary urge incontinence and no plan to receive it during the intervention
- No previous neurostimulation for urinary urge incontinence and no plan to receive it during the intervention English speaking
- A score of >24 on the Montreal Cognitive Assessment
Who cannot join
- The following exclusions are applied, as they could seriously limit participation or confound participant response to the intervention:
- Predominantly stress, mixed, or other type of incontinence as determined by question 3 on the 3 Incontinence Questions
- Currently taking medications for Alzheimer's disease or other dementias; these medications could interfere with their participation
- Known neurologic disease acknowledged to impact bladder function including Parkinson's disease, spinal cord injury, or stroke affecting urinary control; these diseases provide cause for urinary urge incontinence and as such the participant would be unlikely to benefit from the intervention
- Current symptomatic urinary tract infection that has not resolved prior to the start of intervention
- Current bladder infection that has not resolved prior to the start of intervention
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- Use of an assistive device for ambulation (such as a cane, walker, or wheelchair) and feels that difficulties with bladder management are related to the slowed time in visiting the restroom ("Was urinary urge incontinence a problem before you began using the assistive device?")
- Functionally incontinent, in other words, having a mental or physical condition that prevents a person from visiting the restroom in time
- Ever diagnosed with interstitial cystitis
- Self-report of vaginal bulge protruding outside of the vagina
- Past participation in a formal program of mindfulness-based stress reduction
- Substantial, uncorrected hearing loss
- Substantial, uncorrected vision loss
- Limitations that preclude completing study questionnaires or surveys, such as difficulties with reading and writing or a cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Mindfulness-Based Stress Reduction With the Health Enhancement Program in the Treatment of Urinary Urge Incontinence in Older Adult Women: A Pilot Feasibility and Randomized Controlled Trial
The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.
Read the detailed description
The overarching goal of this research is to evaluate potential treatment options for older women with symptoms of urinary urge incontinence, with a specific focus on Mindfulness-Based Stress Reduction, a promising therapeutic approach in preliminary studies and one increasingly used to treat symptoms associated with brain-visceral interactions. Feasibility and preliminary efficacy will be tested in two randomized study arms: a Mindfulness-Based Stress Reduction intervention group and a Health Enhancement Program intervention comparison group.
This research study will explore the feasibility and preliminary efficacy of treating urinary urge incontinence in older adult women with mindfulness-based stress reduction in comparison to the health enhancement program through a randomized controlled pilot study. Feasibility determinants will include both research feasibility (recruitment, retention, treatment fidelity) and intervention feasibility (acceptability, tolerability, treatment adherence). Clinical outcomes to evaluate preliminary intervention efficacy will include severity of urinary urge incontinence symptoms, bother of urinary urge incontinence symptoms, perceived stress, and perceived level of self-efficacy of self-management of urinary urge incontinence symptoms. Preliminary efficacy of the intervention will also be evaluated with the Patient Global Impression of Improvement, a process measure that rates the patient's "response of a condition to a therapy" (Ryan, n.d., p. 1).
This combined pilot feasibility study and randomized controlled trial will evaluate specific factors crucial to the success of a large trial to evaluate the effect of Mindfulness-Based Stress Reduction on urinary urge incontinence in older adult women. Moore (2011) recommended that the pilot study design parallel the future larger study, particularly when evaluating feasibility in the pilot study. The capacity for hypothesis testing, or establishing causal inference is limited in a pilot study due to insufficient power; however, the information from efficacy testing is vital in informing future larger scale clinical trials. This study will serve as a necessary step for the development of effectiveness trials of Mindfulness-Based Stress Reduction in treatment of urinary urge incontinence in older adult women by informing and guiding evaluation, implementation, and dissemination.
- Being tested
- Mindfulness-Based Stress Reduction, Health Enhancement Program
- Keywords
- urinary urge incontinence, urinary incontinence, older adult women, older adults, mindfulness-based stress reduction, health enhancement program, feasibility, randomized controlled trial, complementary, integrative, therapies
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
This experimental arm presents the actual Mindfulness-Based Stress Reduction program as developed in the late seventies and early eighties in its original eight week format
Health Enhancement ProgramBehavioural
This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | 8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Health Enhancement Program | Active comparator | 8 week manualized, standardized health enhancement program, taught by a certified health education specialist Receives: Behavioral: Health Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of potential participants contacted
number of people who contacted PI during recruitment process, including the place they heard about the study
Measured: 10 weeks
number of enrolled participants completing the study
number of participants who attended at least five of nine classes number of excused absences number of unexcused absences
Measured: 12 weeks
percentage of course content delivered during intervention
weekly interventionist report on what was taught participants perception of course content delivered measured by a checklist of concepts covered in the weekly interventions at study completion
Measured: 44 weeks
positive or negative coded responses to the question "How did it go today?"
data coded from two participants' responses after each class in each arm
Measured: 8 weeks
number of participants who completed each week's homework practice
participants mark on homework practice log and submit weekly
Measured: 8 weeks
number of participants recruited for enrollment
potential participants who were interested in the study
Measured: 10 weeks
number of potential participants who are eligible to enroll
number of people who passed the screening process via calls or emails
Measured: 10 weeks
consent rate
number of participants who are willing to sign consent document at enrollment interview; number who pass the Montreal Cognitive Assessment and are willing to sign consent document
Measured: 10 weeks
number of participants enrolled
number of people who enrolled into the study
Measured: 10 weeks
number of dropouts due to stated distress from or dislike of either intervention experience (as opposed to someone needing to withdraw due to a family emergency or illness)
participant self-report of what made the intervention challenging - why they were unable or unwilling to complete the course
Measured: 8 weeks
- number of minutes of homework practice each week
totaled from daily numbers reported by participant
Measured: 8 weeks
Secondary outcomes (5)
change in symptom severity
measured by the Incontinence Severity Index
Measured: 16 weeks, 6 months
change in symptom bother
measured by the Overactive Bladder questionnaire, short form
Measured: 16 weeks, 6 months
change in perceived stress
measured by the Perceived Stress Scale
Measured: 16 weeks, 6 months
change in perceived self-efficacy
measured by the Geriatric Self Efficacy Index for Urinary Incontinence
Measured: 16 weeks, 6 months
self report of rate and trajectory of change in participant impression of improvement
measured by the Patient Global Impression of Improvement
Measured: 16 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start3 Feb 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two armed study with intervention and comparison groups running parallel to one another
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Felsted, University of Utah
- Investigators
- Katarina F Felsted, MS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176901
- Sponsor's protocol ID
- 00095461
- Acronym
- SHUW
- Status last verified
- Feb 2019
- First submitted
- 27 Apr 2017
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Mindfulness-Based Stress Reduction With the Health Enhancement Program in the Treatment of Urinary Urge Incontinence in Older Adult Women: A Pilot Feasibility and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03176901
- Acronym / sponsor ID
- SHUW / 00095461
- Keywords
- urinary urge incontinence, urinary incontinence, older adult women, older adults, mindfulness-based stress reduction, health enhancement program, feasibility, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 6 Jun 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.
The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.
Detailed description
The overarching goal of this research is to evaluate potential treatment options for older women with symptoms of urinary urge incontinence, with a specific focus on Mindfulness-Based Stress Reduction, a promising therapeutic approach in preliminary studies and one increasingly used to treat symptoms associated with brain-visceral interactions. Feasibility and preliminary efficacy will be tested in two randomized study arms: a Mindfulness-Based Stress Reduction intervention group and a Health Enhancement Program intervention comparison group.
This research study will explore the feasibility and preliminary efficacy of treating urinary urge incontinence in older adult women with mindfulness-based stress reduction in comparison to the health enhancement program through a randomized controlled pilot study. Feasibility determinants will include both research feasibility (recruitment, retention, treatment fidelity) and intervention feasibility (acceptability, tolerability, treatment adherence). Clinical outcomes to evaluate preliminary intervention efficacy will include severity of urinary urge incontinence symptoms, bother of urinary urge incontinence symptoms, perceived stress, and perceived level of self-efficacy of self-management of urinary urge incontinence symptoms. Preliminary efficacy of the intervention will also be evaluated with the Patient Global Impression of Improvement, a process measure that rates the patient's "response of a condition to a therapy" (Ryan, n.d., p. 1).
This combined pilot feasibility study and randomized controlled trial will evaluate specific factors crucial to the success of a large trial to evaluate the effect of Mindfulness-Based Stress Reduction on urinary urge incontinence in older adult women. Moore (2011) recommended that the pilot study design parallel the future larger study, particularly when evaluating feasibility in the pilot study. The capacity for hypothesis testing, or establishing causal inference is limited in a pilot study due to insufficient power; however, the information from efficacy testing is vital in informing future larger scale clinical trials. This study will serve as a necessary step for the development of effectiveness trials of Mindfulness-Based Stress Reduction in treatment of urinary urge incontinence in older adult women by informing and guiding evaluation, implementation, and dissemination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two armed study with intervention and comparison groups running parallel to one another
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress Reduction8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor |
| Health Enhancement Program | Active comparator | Behavioral: Health Enhancement Program8 week manualized, standardized health enhancement program, taught by a certified health education specialist |
Who may qualify
- Ages
- 55 to 105 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The following eligibility criteria must be met for the potential participant to be considered for enrollment.
- The study is enrolling older adult women, with urinary urge incontinence.
- They cannot be currently treating their urinary urge incontinence with medication as this will confound results.
- Women who have attempted more extreme treatments and are still experiencing urinary urge incontinence will not be considered as potential participants, as it is unlikely that mindfulness-based stress reduction would treat urinary urge incontinence that is refractory to that degree.
- Participants must be English speaking, as the interventions and homework will be delivered in English.
Key exclusion criteria (14 listed)
- The following exclusions are applied, as they could seriously limit participation or confound participant response to the intervention:
- Predominantly stress, mixed, or other type of incontinence as determined by question 3 on the 3 Incontinence Questions
- Currently taking medications for Alzheimer's disease or other dementias; these medications could interfere with their participation
- Known neurologic disease acknowledged to impact bladder function including Parkinson's disease, spinal cord injury, or stroke affecting urinary control; these diseases provide cause for urinary urge incontinence and as such the participant would be unlikely to benefit from the intervention
- Current symptomatic urinary tract infection that has not resolved prior to the start of intervention
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 |
|---|---|---|
| Mindfulness-Based Stress ReductionThis experimental arm presents the actual Mindfulness-Based Stress Reduction program as developed in the late seventies and early eighties in its original eight week format | Behavioural | Mindfulness-Based Stress Reduction |
| Health Enhancement ProgramThis active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009. | Behavioural | Health Enhancement Program |
Primary outcome
Number of potential participants contacted
Time frame: 10 weeks
number of people who contacted PI during recruitment process, including the place they heard about the study
number of enrolled participants completing the study
Time frame: 12 weeks
number of participants who attended at least five of nine classes number of excused absences number of unexcused absences
percentage of course content delivered during intervention
Time frame: 44 weeks
weekly interventionist report on what was taught participants perception of course content delivered measured by a checklist of concepts covered in the weekly interventions at study completion
positive or negative coded responses to the question "How did it go today?"
Time frame: 8 weeks
data coded from two participants' responses after each class in each arm
number of participants who completed each week's homework practice
Time frame: 8 weeks
participants mark on homework practice log and submit weekly
number of participants recruited for enrollment
Time frame: 10 weeks
potential participants who were interested in the study
number of potential participants who are eligible to enroll
Time frame: 10 weeks
number of people who passed the screening process via calls or emails
consent rate
Time frame: 10 weeks
number of participants who are willing to sign consent document at enrollment interview; number who pass the Montreal Cognitive Assessment and are willing to sign consent document
number of participants enrolled
Time frame: 10 weeks
number of people who enrolled into the study
number of dropouts due to stated distress from or dislike of either intervention experience (as opposed to someone needing to withdraw due to a family emergency or illness)
Time frame: 8 weeks
participant self-report of what made the intervention challenging - why they were unable or unwilling to complete the course
- number of minutes of homework practice each week
Time frame: 8 weeks
totaled from daily numbers reported by participant
5 secondary outcomes
change in symptom severity
Time frame: 16 weeks, 6 months
change in symptom bother
Time frame: 16 weeks, 6 months
change in perceived stress
Time frame: 16 weeks, 6 months
change in perceived self-efficacy
Time frame: 16 weeks, 6 months
self report of rate and trajectory of change in participant impression of improvement
Time frame: 16 weeks, 6 months
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 15 Feb 2019.
- 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.
Katarina F Felsted, MS principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction and Health Enhancement Program in people with Urinary Incontinence, Urge and Urinary Incontinence in Old Age, run by University of Utah 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 15 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 15 Feb 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?
Number of potential participants contacted (time frame: 10 weeks). The study lists 11 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 15 Feb 2019.