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The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

NCT02049840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-09-28

No results posted yet for this study

Summary

This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Altis Single Incision Sling System

Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Jean-Nicolas Cornu, Pr · Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2019-11-04
Completion
2021-07-21

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • 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 NCT02049840 on ClinicalTrials.gov