At a glance
ClinicalIndex Comparison RecordN/ACompleted· 113 enrolled
Drug / intervention
Altis® Single Incision Sling System (SIS)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.
The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
In Brief
A clinical study evaluating Altis® Single Incision Sling System (SIS) for Stress Urinary Incontinence. Completed, enrolled 113 participants across 17 sites in 2 countries.
Detailed Summary
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedJan 2011
Primary CompletionJul 2012
Study CompletionJan 2014
TodayJul 2026
First PostedJan 7, 2011
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2012
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.5 years ago
Interventions
Altis® Single Incision Sling System (SIS)device
The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence.