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Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

NCT02348112 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 416

Last updated 2023-12-04

Study results available
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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.

Conditions

  • Stress Urinary Incontinence

Interventions

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.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Ty Erickson, MD · Rosemark WomenCare Specialists

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348112 on ClinicalTrials.gov