Mixed Incontinence: Medical Or Surgical Approach?
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: Non-Surgical Intervention; Surgical
Intervention description: Both oral urge incontinence medication and behavioral treatment; Initial surgical (stress incontinence surgery) treatment approach.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Stress urinary incontinence, Mixed, Urge

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.
    

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.