Value of Urodynamic Evaluation
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: Office evaluation; UDS
Intervention description: Office evaluation; Urodynamics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 630.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Stress urinary incontinence, Mixed, Urge

Summary:

      Although no reliable and specific figures are available for the total expenditure on UDS, UDS
      is commonly performed for patients with urinary incontinence (UI) regardless of gender and
      age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are
      expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported
      insufficient evidence with which to answer the following key research questions related to
      UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do
      alterations in clinical decisions made in response to UDS results improve the clinical
      outcomes?
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female

          2. Predominant SUI as evidenced by all of the following:

               1. Self-reported stress-type UI symptoms, of duration >3 months*

               2. MESA stress symptom score (percent of total possible stress score) greater than
                  MESA urge symptom score (percent of total possible urge score)

          3. Observation of leakage by provocative stress test at any volume

          4. Eligible for randomization to either treatment group

          5. Eligible for SUI surgery

          6. Desires non-conservative therapy for SUI

          7. PVR <150ml by any method. (May repeat once if initial measure is abnormal)

          8. Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) or
             negative UA or negative culture

          9. Available to initiate SUI treatment within 6 weeks of randomization

         10. Available for 12-months of follow-up and able to complete study assessments, per
             clinician judgment.

         11. Signed consent form.

               -  Patient can be rescreened after respective time interval has been met.

        Exclusion Criteria:

          1. Age <21 years*

          2. Currently undergoing or has had recommended treatment of apical or anterior prolapse

          3. No anterior or apical prolapse > +1 on standing straining prolapse exam

          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. History of pelvic radiation therapy

          8. Previous incontinence surgery

          9. Current catheter use

         10. Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)

         11. Previous (i.e. repaired) or current urethral diverticulum

         12. Prior augmentation cystoplasty or artificial sphincter

         13. Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.

         14. Any pelvic surgery within the last 3 months*

         15. Previous placement of synthetic mesh on a vaginal approach in the anterior compartment

         16. Participation in another treatment intervention trial that might influence results of
             this trial.

         17. A urodynamic result reviewed by the investigator in the preceding 12 months or any
             recollection by the investigator of urodynamic results on that subject.

               -  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.