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Mixed Incontinence: Medical Or Surgical Approach?


Phase 4
21 Years
N/A
Not Enrolling
Female
Urinary Incontinence

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Trial Information

Mixed Incontinence: Medical Or Surgical Approach?


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Optimal Outcome of Treatment at 6 Months

Outcome 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".

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Ann Gormley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Federal Government

Study ID:

MIMOSA (terminated)

NCT ID:

NCT00803270

Start Date:

October 2008

Completion Date:

March 2009

Related Keywords:

  • Urinary Incontinence
  • Stress urinary incontinence, Mixed, Urge
  • Urinary Incontinence

Name

Location

University of AlabamaBirmingham, Alabama  
Loyola University Medical CenterMaywood, Illinois  60153
University of PittsburghPittsburgh, Pennsylvania  15261
University of UtahSalt Lake City, Utah  
University of MarylandBaltimore, Maryland  21201
University of CaliforniaSan Francisco, California  94108
University of Texas Health Sciences CenterSan Antonio, Texas  
Oakwood Hospital/Cancer CenterDearborn, Michigan  48123
University of Texas SouthwesternDallas, Texas  75390
Beaumont HospitalRoyal Oak, Michigan  48073