NCT02348112

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 416 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Altis Single Incision Sling	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.
DEVICE	Transobturator or Retropubic Sling	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2015-01-28
• Last updated: 2023-12-04
• Results posted: 2023-11-21

Locations

27 sites across 2 countries: United States, Canada