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Feasibility Period ended.
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| University of California, San Diego | OTHER |
| University of Maryland | OTHER |
| University of Pittsburgh |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Non Surgical Treatment | Active Comparator | The non-surgical treatment will include two components:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Surgical Intervention | Drug | Both oral urge incontinence medication and behavioral treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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Inclusion Criteria:
Exclusion Criteria:
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*â€
Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage
Current catheter use
Unevaluated hematuria
Participation in another trial that may influence the results of this study
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| Name | Affiliation | Role |
|---|---|---|
| Ann Gormley, MD | Dartmouth-Hitchcock Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19625327 | Background | 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. |
| Label | URL |
|---|---|
| Urinary Incontinence Treatment Network (UITN) Public Website | View source |
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All enrolled participants were randomized.
40 women were screened, 29 met eligibility criteria and 27 were enrolled between November, 2008 and March, 2009. The trial was terminated in March 2009 due to inadequate enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Treatment | Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. |
| FG001 | Non Surgical Treatment | The non-surgical treatment will include two components:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Treatment | Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. |
| BG001 | Non Surgical Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Participants who attended 6 month follow-up visit | Posted | Number | participants | 6 Months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Treatment | Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder perforation | Renal and urinary disorders | Systematic Assessment |
Early termination leading to small numbers of participants for data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne M. Stoddard | New England Resesarch Institutes | 617-972-3331 | astoddard@neriscience.com |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| University of Texas | OTHER |
| The University of Texas at San Antonio | OTHER |
| University of Utah | OTHER |
| Beaumont Hospital | OTHER |
| Loyola University | OTHER |
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| Surgical | Procedure | Initial surgical (stress incontinence surgery) treatment approach. |
|
|
| 3 months |
| San Diego |
| California |
| 92103 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Oakwood Hospital/Cancer Center | Dearborn | Michigan | 48123 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Texas Health Sciences Center | San Antonio | Texas | 78229-3900 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
The non-surgical treatment will include two components:
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Non Surgical Treatment | The non-surgical treatment will include two components:
|
|
|
|
| Secondary | 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." | Participants who attended 3 month follow-up visit | Posted | Number | participants | 3 months |
|
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Non Surgical Treatment | The non-surgical treatment will include two components:
| 0 | 13 | 1 | 13 |
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |