Phase 4 N=630 Randomized Treatment

Value of Urodynamic Evaluation

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT00803959 ↗

Enrolled (actual)

630

Serious AEs

8.1%

Results posted

Aug 2013

Primary outcome: Primary: Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos. — 77.2; 76.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Office evaluation (Other); UDS (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Carelon Research
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.	77.2; 76.9	—
SECONDARY Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months	78.9; 77.2	0.63
SECONDARY Patient Global Impression Index	90.8; 91.9	0.68
SECONDARY Change in Bother as Measured by the UDI	-98.4; -100.2	0.68
SECONDARY Change in Severity as Measured by the ISI	-5.7; -6.0	0.40
SECONDARY Change in MESA Stress Score	-60.2; -61.5	0.50
SECONDARY Change in MESA Urge Score	-22.2; -19.7	0.19
SECONDARY Change in Quality of Life as Measured by the IIQ	-37.3; -35.9	0.49
SECONDARY Change in Quality of Life as Measured by the SF-12	7.3; 5.0	0.02 sig
SECONDARY Change in Severity as Measured by the PGI-S	-1.8; -1.8	0.51
SECONDARY Moderate or Severe Severity as Measured by the PGI-S	5.6; 7.0	0.51
SECONDARY Patient Satisfaction With Treatment Outcome	82.2; 79.5	0.28
SECONDARY Stress Test at 12 Mos	11.7; 16.0	0.19

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

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 +1 on standing straining prolapse exam
Pregnant or has not completed child bearing.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00803959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.