Status:
COMPLETED
Value of Urodynamic Evaluation
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
University of Alabama at Birmingham
University of California, San Diego
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief 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 typ...
Eligibility Criteria
Inclusion
- Female
- Predominant SUI as evidenced by all of the following:
- Self-reported stress-type UI symptoms, of duration \>3 months\*
- MESA stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
- Observation of leakage by provocative stress test at any volume
- Eligible for randomization to either treatment group
- Eligible for SUI surgery
- Desires non-conservative therapy for SUI
- PVR \<150ml by any method. (May repeat once if initial measure is abnormal)
- Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture
- Available to initiate SUI treatment within 6 weeks of randomization
- Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
- Signed consent form.
- Patient can be rescreened after respective time interval has been met.
Exclusion
- Age \<21 years\*
- Currently undergoing or has had recommended treatment of apical or anterior prolapse
- No anterior or apical prolapse \> +1 on standing straining prolapse exam
- Pregnant or has not completed child bearing.
- \<12 months post-partum\*†
- Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage
- History of pelvic radiation therapy
- Previous incontinence surgery
- Current catheter use
- Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
- Previous (i.e. repaired) or current urethral diverticulum
- Prior augmentation cystoplasty or artificial sphincter
- Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
- Any pelvic surgery within the last 3 months\*
- Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
- Participation in another treatment intervention trial that might influence results of this trial.
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00803959
Start Date
November 1 2008
End Date
June 1 2010
Last Update
August 6 2013
Active Locations (10)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California
San Diego, California, United States, 92103
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
University of Maryland
Baltimore, Maryland, United States, 21201