Status:
TERMINATED
Mixed Incontinence: Medical Or Surgical Approach?
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
University of Alabama at Birmingham
University of California, San Diego
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00803270
Start Date
October 1 2008
End Date
March 1 2009
Last Update
May 10 2013
Active Locations (10)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California
San Diego, California, United States, 92103
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
University of Maryland
Baltimore, Maryland, United States, 21201