Urinary IncontinencePhase 4MIMOSANCT00803270
Mixed Incontinence: Medical Or Surgical Approach?
A Phase 4 study testing Non-Surgical Intervention and Surgical in people with Urinary Incontinence, run by Carelon Research at 10 sites in United States.
Trial summary
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Non-Surgical Intervention and Surgical
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2008to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C)
- Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
- Incontinence symptoms present for at least (3) months*
- Bladder capacity > 200cc (by any method)
- Urodynamic Stress Incontinence
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- Eligible for both treatment interventions
- Available to start intervention within 6 weeks
- Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites)
- Available for 12 months of follow-up and able to complete study assessments as per clinician judgment
- Signed consent form
Who cannot join
- Age <21 years*
- Currently undergoing or recommended to undergo treatment of pelvic organ prolapse
- Other indicated/planned concomitant surgery
- Pregnant or has not completed child bearing*
- <12 months post-partum*†
- Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage
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- Current catheter use
- Unevaluated hematuria
- Participation in another trial that may influence the results of this study
- Patient can be rescreened after respective time interval has been met. †"Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35294
University of Texas Southwestern
Dallas, Texas, 75390
Oakwood Hospital/Cancer Center
Dearborn, Michigan, 48123
Loyola University Medical Center
Maywood, Illinois, 60153
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Beaumont Hospital
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
University of Texas Health Sciences Center
San Antonio, Texas, 78229-3900
University of California
San Diego, California, 92103
About this study
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
Read the detailed description
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
- Conditions
- Urinary Incontinence
- Being tested
- Non-Surgical Intervention, Surgical
- Keywords
- Stress urinary incontinence, Mixed, Urge
- 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.
Non-Surgical InterventionDrug
Also called Non-Surgical Treatment
Both oral urge incontinence medication and behavioral treatment
SurgicalProcedure or surgery
Also called Surgical Treatment
Initial surgical (stress incontinence surgery) treatment approach.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment | Active comparator | Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. Receives: Procedure: Surgical |
| Non Surgical Treatment | Active comparator | The non-surgical treatment will include two components:
1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and
2. Behavioral therapy. Receives: Drug: Non-Surgical Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Outcome of Treatment at 6 Months
Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".
Measured: 6 Months
Secondary outcomes (1)
Optimal Outcome of Treatment at 3 Months
Composite measure defined as "much better" or "very much better" om PGI-I and "normal" or "mild" on PGI-S. PGI-I is a single item: "Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment" with responses ranging from 1="Very much better" to 7="Very much worse." PGI-S is a single items: "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1="Normal" to 4="Severe."
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Feasibility Period ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas, The University of Texas at San Antonio, University of Utah, Beaumont Hospital, Loyola University
- Responsible party
- Sponsor
- Investigators
- Ann Gormley, MD, Study chair, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803270
- Sponsor's protocol ID
- MIMOSA (terminated)
- Acronym
- MIMOSA
- Status last verified
- May 2013
- First submitted
- 4 Dec 2008
- Last updated
- 10 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brubaker L, Moalli P, Richter HE, Albo M, Sirls L, Chai T, Kraus SR, Norton P, Chang D, Tennstedt SL. Challenges in designing a pragmatic clinical trial: the mixed incontinence -- medical or surgical approach (MIMOSA) trial experience. Clin Trials. 2009 Aug;6(4):355-64. doi: 10.1177/1740774509339239. Epub 2009 Jul 22.
PubMed 19625327
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Incontinence: Medical Or Surgical Approach?
- ClinicalTrials.gov ID
- NCT00803270
- Acronym / sponsor ID
- MIMOSA / MIMOSA (terminated)
- Conditions
- Urinary Incontinence
- Keywords
- Stress urinary incontinence, Mixed, Urge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility Period ended.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas, The University of Texas at San Antonio, University of Utah, Beaumont Hospital, Loyola University
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 11 May 2012
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 compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
Detailed description
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment | Active comparator | Procedure: SurgicalSurgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. |
| Non Surgical Treatment | Active comparator | Drug: Non-Surgical InterventionThe non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and 2. Behavioral therapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C)
- Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
- Incontinence symptoms present for at least (3) months*
- Bladder capacity > 200cc (by any method)
Key exclusion criteria (10 listed)
- Age <21 years*
- Currently undergoing or recommended to undergo treatment of pelvic organ prolapse
- Other indicated/planned concomitant surgery
- Pregnant or has not completed child bearing*
- <12 months post-partum*†
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 |
|---|---|---|
| Non-Surgical InterventionAlso: Non-Surgical TreatmentBoth oral urge incontinence medication and behavioral treatment | Drug | Non Surgical Treatment |
| SurgicalAlso: Surgical TreatmentInitial surgical (stress incontinence surgery) treatment approach. | Procedure or surgery | Surgical Treatment |
Primary outcome
Optimal Outcome of Treatment at 6 Months
Time frame: 6 Months
Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".
1 secondary outcome
Optimal Outcome of Treatment at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19625327Brubaker L, Moalli P, Richter HE, Albo M, Sirls L, Chai T, Kraus SR, Norton P, Chang D, Tennstedt SL. Challenges in designing a pragmatic clinical trial: the mixed incontinence -- medical or surgical approach (MIMOSA) trial experience. Clin Trials. 2009 Aug;6(4):355-64. doi: 10.1177/1740774509339239. Epub 2009 Jul 22.
- Urinary Incontinence Treatment Network (UITN) Public WebsiteLink provided by the sponsor.
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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.
Ann Gormley, MD study chair
Dartmouth-Hitchcock Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-Surgical Intervention and Surgical in people with Urinary Incontinence, run by Carelon Research at 10 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Optimal Outcome of Treatment at 6 Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803270, which also lists 1 linked publication.
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 May 2013.