Mixed Incontinence: Medical Or Surgical Approach?

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HealthCore-NERI; New England Research Institutes
• Collaborators: 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 Maryland, College Park; University of Pittsburgh; University of Texas; University of Utah

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.