Value of Urodynamic Evaluation (ValUE)

Carelon Research

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Other: UDS; Other: Office evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT00803959

ValUE (completed)

Details and patient eligibility

About

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?

Enrollment: 630 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

630 participants in 2 patient groups

No UDS

Active Comparator group

Description:

Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation only.

Treatment:

Other: Office evaluation

UDS

Active Comparator group

Description:

Women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence (UI) who receive a basic office evaluation with preoperative urodynamic studies prior to surgery.

Treatment:

Other: UDS

Other: Office evaluation