Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
27 participants
INTERVENTIONAL
2008-10-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Surgical
Initial surgical (stress incontinence surgery) treatment approach.
Non Surgical Treatment
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.
Non-Surgical Intervention
Both oral urge incontinence medication and behavioral treatment
Interventions
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Non-Surgical Intervention
Both oral urge incontinence medication and behavioral treatment
Surgical
Initial surgical (stress incontinence surgery) treatment approach.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
4. Incontinence symptoms present for at least (3) months\*
5. Bladder capacity \> 200cc (by any method)
6. Urodynamic Stress Incontinence
7. Eligible for both treatment interventions
8. Available to start intervention within 6 weeks
9. Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites)
10. Available for 12 months of follow-up and able to complete study assessments as per clinician judgment
11. Signed consent form
Exclusion Criteria
2. Currently undergoing or recommended to undergo treatment of pelvic organ prolapse
3. Other indicated/planned concomitant surgery
4. Pregnant or has not completed child bearing\*
5. \<12 months post-partum\*†
6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage
7. Current catheter use
8. Unevaluated hematuria
9. 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.
21 Years
FEMALE
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
University of California, San Diego
OTHER
University of Maryland
OTHER
University of Pittsburgh
OTHER
University of Texas
OTHER
The University of Texas at San Antonio
OTHER
University of Utah
OTHER
Beaumont Hospital
OTHER
Loyola University
OTHER
Carelon Research
OTHER
Responsible Party
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Principal Investigators
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Ann Gormley, MD
Role: STUDY_CHAIR
Dartmouth-Hitchcock Medical Center
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California
San Diego, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Oakwood Hospital/Cancer Center
Dearborn, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
Related Links
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Urinary Incontinence Treatment Network (UITN) Public Website
Other Identifiers
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MIMOSA (terminated)
Identifier Type: -
Identifier Source: org_study_id
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