Mixed Incontinence: Medical Or Surgical Approach?

NCT00803270 | Terminated Phase 4 Results DMC

• 1 other identifier: MIMOSA (terminated)
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 10

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.

Conditions

Urinary Incontinence

Keywords

Stress urinary incontinence, Mixed, Urge

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Optimal Outcome of Treatment at 3 Months

  3 months

Study Arms (2)

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.

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.

Drug: Non-Surgical Intervention

Interventions

Non-Surgical Intervention DRUG

Both oral urge incontinence medication and behavioral treatment

Also known as: Non-Surgical Treatment

Non Surgical Treatment

Surgical PROCEDURE

Initial surgical (stress incontinence surgery) treatment approach.

Also known as: Surgical Treatment

Surgical Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carelon Research: lead
• University of Alabama at Birmingham: collaborator
• University of California, San Diego: collaborator
• University of Maryland: collaborator
• University of Pittsburgh: collaborator
• University of Texas: collaborator
• The University of Texas at San Antonio: collaborator
• University of Utah: collaborator
• Beaumont Hospital: collaborator
• Loyola University: collaborator

Study Sites (10)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California

San Diego, California, 92103, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Oakwood Hospital/Cancer Center

Dearborn, Michigan, 48123, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229-3900, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 19625327 BACKGROUND

Related Links

• Urinary Incontinence Treatment Network (UITN) Public Website

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of participants for data analysis.

Results Point of Contact

• Title: Anne M. Stoddard
• Organization: New England Resesarch Institutes

astoddard@neriscience.com

617-972-3331

Study Officials

• Ann Gormley, MD

  Dartmouth-Hitchcock Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 10, 2013
• Results First Posted: May 11, 2012

Record last verified: 2013-05

Locations

US (10)