Clinical trial NCT00803270: Mixed Incontinence: Medical Or Surgical Approach?
Official title: Mixed Incontinence: Medical Or Surgical Approach?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence, Mixed, Urge
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of California, San Diego
name: University of Maryland
name: University of Pittsburgh
name: University of Texas
name: The University of Texas at San Antonio
name: University of Utah
name: Beaumont Hospital
name: Loyola University
First posted: 2008-12-05
Enrollment: 27
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Optimal Outcome of Treatment at 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Optimal Outcome of Treatment at 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University of California
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital/Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ann Gormley, MD
role: STUDY_CHAIR
References:
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.