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A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

NCT04115605 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 599

Last updated 2022-03-28

No results posted yet for this study

Summary

The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

Conditions

  • Urinary Incontinence, Stress

Interventions

DEVICE

Altis Single Incision Sling

Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Grégoire Capon, MD · CHU Pellegrin, Bordeaux, France

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-27
Primary Completion
2021-09-22
Completion
2023-09-22

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain

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 NCT04115605 on ClinicalTrials.gov