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NCT00803959 · ClinicalTrials.gov registry record · Phase 4
Value of Urodynamic Evaluation
A Phase 4 study, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 630
- Enrollment target
NCT00803959: Completed Phase 4 study, sponsored by Carelon Research.
NCT00803959 is a Phase 4 study that has completed, run by Carelon Research. The registered enrollment target is 630 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00803959, a Phase 4 study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 630 participants
- Enrollment target
Study 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?
Primary Outcome
Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better" at 12 months.
Interventions
- OTHER Office evaluation
- OTHER UDS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00803959 record still lists
NCT00803959 is an interventional study that assigns participants to a tested intervention. The registered 630 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 2 interventions - of which Office evaluation is the first listed.
NCT00803959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00803959 about?
NCT00803959 is a clinical study titled "Value of Urodynamic Evaluation". 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, an...
What is the current status of trial NCT00803959?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 630 participants. The study started on 2008-11. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00803959?
The interventions under investigation include: Office evaluation (OTHER), UDS (OTHER).
Who is sponsoring clinical trial NCT00803959?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00803959's enrollment target sits among peer trials
630 129th of 2000 higher than 1,871 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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