Urinary IncontinencePhase 1/2NCT00125177
IRIS: Incontinence Research Intervention Study
A Phase 1/2 study testing Knack therapy in people with Urinary Incontinence and Urinary Incontinence, Stress, run by University of Michigan at 1 site in United States.
Trial summary
The IRIS project stands for Incontinence Research Intervention Study. The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy, a self-help treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Stress
- What is being tested?
- Knack therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Apr 2008
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are incontinent
- Women who experience leakage with coughing, sneezing or exercising
- Women who are generally healthy
- Women who are over the age of eighteen
- Women who are not pregnant nor expecting to become pregnant within a year
Who cannot join
- No urine leakage when coughing, sneezing, or exercising
- Under the age of eighteen
- Pregnant or expecting to become pregnant
- Untreated urinary tract infection
- Pronounced pain or discomfort with pelvic exams
- History of neurologic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, School of Nursing
Ann Arbor, Michigan, 48109
About this study
Official title: Office for Research on Women's Health (ORWH): Specialized Centers of Research (SCOR) on Sex and Gender Factors Affecting Women's Health. Project 3: Selection Criteria For Muscle Therapy in SUI
The IRIS project stands for Incontinence Research Intervention Study. The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy, a self-help treatment. The Knack therapy involves learning the skill of performing a pelvic muscle contraction simultaneously with an event known to trigger leakage, in order to stop that leakage.
Read the detailed description
This proposal aims to develop and test, in a general population of women with stress urinary incontinence (SUI), a model for predicting who will succeed in overcoming incontinence long-term (1-year) by simply using Knack therapy (thus avoiding invasive and costly surgery and time consuming Kegel's exercises). Specific Aims are to:
- develop a logistic regression model to predict success with the Knack;
- validate the model by determining the proportion of people who succeed according to who is predicted to succeed; and
- develop long-term effectiveness of the Knack (1-year).
The project will be implemented in three phases: model development (n=160 women), model validation (n~160), and long-term follow-up of women who demonstrate response. This will be evaluated immediately and at 1 month and at 3-months and 1-year.
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress
- Being tested
- Knack therapy
- Keywords
- pelvic muscle therapy, urinary incontinence therapy, stress incontinence intervention, incontinence intervention, Incontinence, SUI, Stress Incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knack therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The short-term outcome of "positive response" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately at 1 month.
Secondary outcomes (1)
Long-term success (3-months and 1-year) is defined both by the paper towel test criteria and by documentation of at least 50% reduction of leakage in diary to reflect success at home.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startJan 2003
- Study completionApr 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Janis M Miller, PhD, APRN, Principal investigator, University of Michigan, School of Nursing, Dept. Obstetrics & GynecologyJohn OL DeLancey, MD, Study director, University of Michigan, Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125177
- Sponsor's protocol ID
- P50HD044406
- Other IDs
- 1P50HD044406, IRBMED# 2002-0635
- Status last verified
- Jul 2005
- First submitted
- 27 Jul 2005
- Last updated
- 10 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office for Research on Women's Health (ORWH): Specialized Centers of Research (SCOR) on Sex and Gender Factors Affecting Women's Health. Project 3: Selection Criteria For Muscle Therapy in SUI
- ClinicalTrials.gov ID
- NCT00125177
- Acronym / sponsor ID
- P50HD044406
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress
- Keywords
- pelvic muscle therapy, urinary incontinence therapy, stress incontinence intervention, incontinence intervention, Incontinence, SUI, Stress Incontinence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2003
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Jul 2005 (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.
The IRIS project stands for Incontinence Research Intervention Study. The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy, a self-help treatment. The Knack therapy involves learning the skill of performing a pelvic muscle contraction simultaneously with an event known to trigger leakage, in order to stop that leakage.
Detailed description
This proposal aims to develop and test, in a general population of women with stress urinary incontinence (SUI), a model for predicting who will succeed in overcoming incontinence long-term (1-year) by simply using Knack therapy (thus avoiding invasive and costly surgery and time consuming Kegel's exercises). Specific Aims are to:
- develop a logistic regression model to predict success with the Knack;
- validate the model by determining the proportion of people who succeed according to who is predicted to succeed; and
- develop long-term effectiveness of the Knack (1-year).
The project will be implemented in three phases: model development (n=160 women), model validation (n~160), and long-term follow-up of women who demonstrate response. This will be evaluated immediately and at 1 month and at 3-months and 1-year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who are incontinent
- Women who experience leakage with coughing, sneezing or exercising
- Women who are generally healthy
- Women who are over the age of eighteen
- Women who are not pregnant nor expecting to become pregnant within a year
Key exclusion criteria (6 listed)
- No urine leakage when coughing, sneezing, or exercising
- Under the age of eighteen
- Pregnant or expecting to become pregnant
- Untreated urinary tract infection
- Pronounced pain or discomfort with pelvic exams
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 |
|---|---|---|
| Knack therapy | Behavioural | – |
Primary outcome
The short-term outcome of "positive response" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately at 1 month.
1 secondary outcome
Long-term success (3-months and 1-year) is defined both by the paper towel test criteria and by documentation of at least 50% reduction of leakage in diary to reflect success at home.
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 10 Nov 2010.
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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.
Janis M Miller, PhD, APRN principal investigator
University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology
John OL DeLancey, MD study director
University of Michigan, Obstetrics & Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Knack therapy in people with Urinary Incontinence and Urinary Incontinence, Stress, run by University of Michigan 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 5 inclusion and 6 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 10 Nov 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The short-term outcome of "positive response" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately at 1 month.. 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 10 Nov 2010.