Mixed Incontinence: Medical Or Surgical Approach?

Urinary Incontinence Clinical Trial

— MIMOSA  

Official title:

Mixed Incontinence: Medical Or Surgical Approach?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00803270
• Other study ID #: MIMOSA (terminated)
• Status: Terminated
• Phase: Phase 4
• First received: December 4, 2008
• Last updated: May 8, 2013
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2013
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Drug:
• Non-Surgical Intervention
Both oral urge incontinence medication and behavioral treatment

Procedure:
• Surgical
Initial surgical (stress incontinence surgery) treatment approach.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Texas Southwestern	Dallas	Texas
United States	Oakwood Hospital/Cancer Center	Dearborn	Michigan
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Beaumont Hospital	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	University of California	San Diego	California

Sponsors (10)

Lead Sponsor	Collaborator
New England Research Institutes	Beaumont Hospital, Loyola University, The University of Texas at San Antonio, University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas, University of Utah

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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".	6 Months	No
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."	3 months	No