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Mixed Incontinence: Medical Or Surgical Approach? (MIMOSA)

Primary Purpose

Urinary Incontinence

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Non-Surgical Intervention
Surgical
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Stress urinary incontinence, Mixed, Urge

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Female
  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:

  1. Age <21 years*
  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.

Sites / Locations

  • University of Alabama
  • University of California
  • Loyola University Medical Center
  • University of Maryland
  • Oakwood Hospital/Cancer Center
  • Beaumont Hospital
  • University of Pittsburgh
  • University of Texas Southwestern
  • University of Texas Health Sciences Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical Treatment

Non Surgical Treatment

Arm Description

Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.

The non-surgical treatment will include two components: Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and Behavioral therapy.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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."

Full Information

First Posted
December 4, 2008
Last Updated
May 8, 2013
Sponsor
Carelon Research
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
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1. Study Identification

Unique Protocol Identification Number
NCT00803270
Brief Title
Mixed Incontinence: Medical Or Surgical Approach?
Acronym
MIMOSA
Official Title
Mixed Incontinence: Medical Or Surgical Approach?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Feasibility Period ended.
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Stress urinary incontinence, Mixed, Urge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Treatment
Arm Type
Active Comparator
Arm Description
Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
Arm Title
Non Surgical Treatment
Arm Type
Active Comparator
Arm Description
The non-surgical treatment will include two components: Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and Behavioral therapy.
Intervention Type
Drug
Intervention Name(s)
Non-Surgical Intervention
Other Intervention Name(s)
Non-Surgical Treatment
Intervention Description
Both oral urge incontinence medication and behavioral treatment
Intervention Type
Procedure
Intervention Name(s)
Surgical
Other Intervention Name(s)
Surgical Treatment
Intervention Description
Initial surgical (stress incontinence surgery) treatment approach.
Primary Outcome Measure Information:
Title
Optimal Outcome of Treatment at 6 Months
Description
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".
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Optimal Outcome of Treatment at 3 Months
Description
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."
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 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*† 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Gormley, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oakwood Hospital/Cancer Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19625327
Citation
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.
Results Reference
background
Links:
URL
http://www.uitn.net
Description
Urinary Incontinence Treatment Network (UITN) Public Website

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Mixed Incontinence: Medical Or Surgical Approach?

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