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NCT04829357 · ClinicalTrials.gov registry record

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

A clinical trial of Stress Urinary Incontinence, sponsored by Ethicon.

Recruiting
Registry status
195
Enrollment target
4
Study locations

NCT04829357: Recruiting study of Stress Urinary Incontinence, sponsored by Ethicon.

NCT04829357 is a study of Stress Urinary Incontinence that is actively recruiting participants, run by Ethicon. The registered enrollment target is 195 participants, above the 157-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (24% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04829357, a study of Stress Urinary Incontinence, is actively recruiting participants, sponsored by Ethicon.

RECRUITING
Registry status
195 participants
Enrollment target
4
Study locations

Study Summary

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

Primary Outcome

Objective cure of Stress Urinary Incontinence (SUI) (treatment success) approximately 5-10 years after surgery, defined as a negative CST

Interventions

  • DEVICE Intervention

Study Locations (4)

Other

  • Bio-Medical University Rome - Rome
  • Ospedale San Pietro Fatebenefratelli - Rome
  • Ospedale Regionale Beata Vergine - Mendrisio

Pennsylvania

  • Institute for Female Pelvic Medicine - North Wales

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2021-09-09
Est. Completion 2038-12-31
Ethicon

38 total trials

What NCT04829357 shows while recruiting

NCT04829357 is an observational study that tracks outcomes without assigning an intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (24% higher).

The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Intervention is the first listed.

NCT04829357 reports a single indexed study location in Other, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04829357 about?

NCT04829357 is a clinical study titled "Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System". The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

What is the current status of trial NCT04829357?

This trial is currently recruiting. The enrollment target is 195 participants. The study started on 2021-09-09. Estimated completion is 2038-12-31.

What conditions does trial NCT04829357 study?

This clinical trial studies the following conditions: Stress Urinary Incontinence.

What interventions are being tested in trial NCT04829357?

The interventions under investigation include: Intervention (DEVICE).

Who is sponsoring clinical trial NCT04829357?

This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04829357 being conducted?

This trial has 4 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stress Urinary Incontinence

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04829357's enrollment target sits among peer trials

195 8th of 35 higher than 28 of 35 other Stress Urinary Incontinence trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04829357, the US trial registry maintained by the National Library of Medicine. NCT04829357 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.