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Value of Urodynamic Evaluation

Phase 4
21 Years
Not Enrolling
Urinary Incontinence

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Trial Information

Value of Urodynamic Evaluation

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

14. Any pelvic surgery within the last 3 months*

15. Previous placement of synthetic mesh on a vaginal approach in the anterior

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Self-reported urinary incontinence, irritative and obstructive symptoms.

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

Ann Gormley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Federal Government

Study ID:

ValUE (completed)



Start Date:

November 2008

Completion Date:

June 2010

Related Keywords:

  • Urinary Incontinence
  • Stress urinary incontinence, Mixed, Urge
  • Urinary Incontinence



University of AlabamaBirmingham, Alabama  
Loyola University Medical CenterMaywood, Illinois  60153
University of PittsburghPittsburgh, Pennsylvania  15261
University of UtahSalt Lake City, Utah  
University of MarylandBaltimore, Maryland  21201
University of CaliforniaSan Francisco, California  94108
University of Texas Health Sciences CenterSan Antonio, Texas  
Oakwood Hospital/Cancer CenterDearborn, Michigan  48123
University of Texas SouthwesternDallas, Texas  75390
Beaumont HospitalRoyal Oak, Michigan  48073