CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 459 enrolled
Drug / intervention
Coaptite®device
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/NCT00996489
NCT00996489N/ACompleted

Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence

Merz North America, Inc.·interventional·Posted Oct 16, 2009·Updated Jul 23, 2019

In Brief

A clinical study evaluating Coaptite® for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency. Completed, enrolled 459 participants across 20 sites.

Detailed Summary

This is a post approval study of Coaptite® in the treatment of female urinary incontinence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2009
Enrollment StartJan 8, 2008
Primary CompletionOct 26, 2015
Study CompletionNov 2, 2015
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 16.7 years ago

Interventions

Coaptite®device

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier