CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 416 enrolled
Drug / intervention
Altis Single Incision Sling +1 moredevice
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/NCT02348112
NCT02348112N/ACompleted
CompareCT.gov

A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence

Coloplast A/S·observational·Posted Jan 28, 2015·Updated Dec 4, 2023

In Brief

An observational study evaluating Altis Single Incision Sling and Transobturator or Retropubic Sling for Stress Urinary Incontinence. Completed, enrolled 416 participants across 27 sites in 2 countries.

Detailed Summary

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartJan 1, 2015
Primary CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 11.4 years ago

Interventions

Altis Single Incision Slingdevice

Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.

Transobturator or Retropubic Slingdevice

Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.