CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 630 enrolled
Drug / intervention
Office evaluation +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00803959
NCT00803959Phase 4Completed

A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery

Carelon Research·interventional·Posted Dec 8, 2008·Updated Aug 6, 2013

In Brief

A Phase 4 clinical trial evaluating Office evaluation and UDS for Urinary Incontinence. Completed, enrolled 630 participants across 10 sites.

Detailed 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?

Study Details

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2008
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.6 years ago

Interventions

Office evaluationother

Office evaluation

UDSother

Urodynamics