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Post-Market Clinical Follow-Up onTVT EXACT® Continence System

NCT04829994 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2026-05-08

No results posted yet for this study

Summary

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Intervention

There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures subjects would receive as part of SOC.

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Weisberg, MD · Ethicon, Inc.

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2030-09-30
Completion
2035-09-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • Denmark
  • France
  • Germany
  • Sweden

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 NCT04829994 on ClinicalTrials.gov