Urinary IncontinencePhase 2TULIPNCT01599715
Translating Unique Learning for Incontinence Prevention
A Phase 2 study testing Instructional DVD and Bladder Health Class in people with Urinary Incontinence, run by University of Michigan at 2 sites in United States.
Trial summary
More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Instructional DVD and Bladder Health Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jan 2015
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, aged 55 years or older
- An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
- Negative for demonstrable UI on the standardized Paper Towel Test
- Willing to undergo vaginal/pelvic examination
- Willing and able to be compliant with visit schedule and study procedures for the study duration
- Provide written informed consent form
- Able to understand and read English
Who cannot join
- Non-ambulatory (patient confined to bed or wheelchair)
- Persistent pelvic pain (defined as daily pelvic pain)
- History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
- Actively taking UI, OAB, or any other bladder control medication.
- Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
- Participation in another research project that may influence the results of this trial
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- Pelvic organ prolapse protruding past the introitus upon straining
- Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
- Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
- History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
- Post void residual > 150 cc
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
University of Pennsylvania Department of Urology
Philadelphia, Pennsylvania, 19104
About this study
Official title: Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55
More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. They also may decrease symptoms of urgency and frequency that do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.
Read the detailed description
The study will attempt to accomplish 3 aims:
Aim 1: Compare outcomes of the two-hour BH Class with the condensed DVD version.
To accomplish this aim we will conduct a comparative effectiveness trial of 600 women 55 years and older randomized to BH Class or DVD. Women will be followed for 24 months post-intervention in order to assess long-term outcomes and sustainability.
Aim 2: Conduct an economic analysis comparing the two-hour BH Class with the DVD version. Describing the costs, quality of life, and analyzing the willingness to pay and employment/ productivity data will be the primary economic focus of this study.
Aim 3: Conduct a qualitative analysis to gain insight into elements of the intervention that contribute to sustainability.
Inclusion/Exclusion Criteria
Inclusion:
- Female, aged 55 years or older
- An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
- Negative for demonstrable UI on the standardized Paper Towel Test
- Willing to undergo vaginal/pelvic examination
- Willing and able to be compliant with visit schedule and study procedures for the study duration
- Provide written informed consent form
- Able to understand and read English
Exclusion:
- Non-ambulatory (patient confined to bed or wheelchair)
- Persistent pelvic pain (defined as daily pelvic pain)
- History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
- Actively taking UI, OAB, or any other bladder control medication.
- Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
- Participation in another research project that may influence the results of this trial
- Pelvic organ prolapse protruding past the introitus upon straining
- Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
- Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
- History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
- Post void residual > 150 cc
- Conditions
- Urinary Incontinence
- Being tested
- Instructional DVD, Bladder Health Class
- Keywords
- Urinary Incontinence, Weak bladder, Frequent urination, Overactive bladder, Urine leakage, Stress incontinence, Urge Incontinence, Pelvic Floor weakness, Pelvic Floor Muscle Exercises, Kegel exercises, Self-Care
- Medical subject headings
- Urinary Incontinence, Nocturnal Enuresis, Urinary Bladder, Overactive, 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.
Instructional DVDBehavioural
Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once.
Bladder Health ClassBehavioural
Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.
| Study group | Role | What they receive |
|---|---|---|
| Instructional DVD Intervention | Other | Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once Receives: Behavioral: Instructional DVD |
| Bladder Health Class Intervention | Other | Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit. Receives: Behavioral: Bladder Health Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translating Unique Learning for Incontinence Prevention (TULIP)
Prevention study for Urinary Incontinence in women over the age of 55 who are fully continent (do not leak urine at all) or mildly continent (leak small drops of urine on occasion). This study will measure the effectiveness of 2 interventions: a bladder health instruction session or Bladder Health DVD administration.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startSep 2010
- Primary completionJan 2015
- Study completionJan 2015
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 MichiganThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Carolyn Sampselle, University of Michigan
- Investigators
- Carolyn Sampselle, PHD, RN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599715
- Sponsor's protocol ID
- The TULIP Project
- Other IDs
- R01NR012011-01
- Acronym
- TULIP
- Status last verified
- May 2016
- First submitted
- 14 May 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Manuscript preparation for data dissemination is currently in progress.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Unique Learning for Incontinence Prevention for Women Over the Age of 55
- ClinicalTrials.gov ID
- NCT01599715
- Acronym / sponsor ID
- TULIP / The TULIP Project
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Weak bladder, Frequent urination, Overactive bladder, Urine leakage, Stress incontinence, Urge Incontinence, Pelvic Floor weakness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 May 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.
More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. They also may decrease symptoms of urgency and frequency that do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.
Detailed description
The study will attempt to accomplish 3 aims:
Aim 1: Compare outcomes of the two-hour BH Class with the condensed DVD version.
To accomplish this aim we will conduct a comparative effectiveness trial of 600 women 55 years and older randomized to BH Class or DVD. Women will be followed for 24 months post-intervention in order to assess long-term outcomes and sustainability.
Aim 2: Conduct an economic analysis comparing the two-hour BH Class with the DVD version. Describing the costs, quality of life, and analyzing the willingness to pay and employment/ productivity data will be the primary economic focus of this study.
Aim 3: Conduct a qualitative analysis to gain insight into elements of the intervention that contribute to sustainability.
Inclusion/Exclusion Criteria
Inclusion:
- Female, aged 55 years or older
- An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
- Negative for demonstrable UI on the standardized Paper Towel Test
- Willing to undergo vaginal/pelvic examination
- Willing and able to be compliant with visit schedule and study procedures for the study duration
- Provide written informed consent form
- Able to understand and read English
Exclusion:
- Non-ambulatory (patient confined to bed or wheelchair)
- Persistent pelvic pain (defined as daily pelvic pain)
- History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
- Actively taking UI, OAB, or any other bladder control medication.
- Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
- Participation in another research project that may influence the results of this trial
- Pelvic organ prolapse protruding past the introitus upon straining
- Absolute absence of pelvic floor muscle strength manifested by zero Brink test (Brink et al., 1994 for pressure and displacement 9
- Evidence of UTI or hematuria - Urine dipstick positive for red blood cells will exclude the participant from enrollment in the study until a microscopic urinalysis is negative. Urine dipstick positive for leukocytes plus nitrates will exclude the participant from enrollment in the study and require further evaluation for UTI.
- History of > 2 recurrent UTI's in the past year and no more than one UTI within 6 months
- Post void residual > 150 cc
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructional DVD Intervention | Other | Behavioral: Instructional DVDParticipants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once |
| Bladder Health Class Intervention | Other | Behavioral: Bladder Health ClassParticipants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, aged 55 years or older
- An additive sum of the frequency (question 1) and volume (question 2) items from the International Consultation on Incontinence Questionnaire-Short Form is ≤5
- Negative for demonstrable UI on the standardized Paper Towel Test
- Willing to undergo vaginal/pelvic examination
- Willing and able to be compliant with visit schedule and study procedures for the study duration
Key exclusion criteria (11 listed)
- Non-ambulatory (patient confined to bed or wheelchair)
- Persistent pelvic pain (defined as daily pelvic pain)
- History of neurologic diseases (e.g. Cerebral Vasular Accident, Parkinson's disease, Multiple sclerosis, Epilepsy, Spinal cord tumor or trauma, spina bifida, current symptomatic herniated disc)
- Actively taking UI, OAB, or any other bladder control medication.
- Other urinary conditions or procedures that may affect continence status (e.g. history of bladder cancer, urethral diverticula, previous augmentation cystoplasty or artificial sphincter; implanted nerve stimulators for urinary symptoms, history of sling surgery for UI or prolapse)
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 |
|---|---|---|
| Instructional DVDParticipants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once. | Behavioural | Instructional DVD Intervention |
| Bladder Health ClassParticipants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit. | Behavioural | Bladder Health Class Intervention |
Primary outcome
Translating Unique Learning for Incontinence Prevention (TULIP)
Time frame: 5 years
Prevention study for Urinary Incontinence in women over the age of 55 who are fully continent (do not leak urine at all) or mildly continent (leak small drops of urine on occasion). This study will measure the effectiveness of 2 interventions: a bladder health instruction session or Bladder Health DVD administration.
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 12 May 2016.
- Individual participant dataSharing planned: Yes. Manuscript preparation for data dissemination is currently in progress.
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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.
Carolyn Sampselle, PHD, RN principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Instructional DVD and Bladder Health Class in people with Urinary Incontinence, run by University of Michigan at 2 sites 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 7 inclusion and 11 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Translating Unique Learning for Incontinence Prevention (TULIP) (time frame: 5 years). 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 12 May 2016.