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NCT00325039 · ClinicalTrials.gov registry record · Phase 4

TOMUS-Trial Of Mid-Urethral Slings

A Phase 4 study, sponsored by Carelon Research.

Completed
Registry status
Phase 4
Development phase
597
Enrollment target

NCT00325039 is a Phase 4 study that has completed, run by Carelon Research. The registered enrollment target is 597 participants.

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The verdict

NCT00325039, a Phase 4 study, has completed, sponsored by Carelon Research.

COMPLETED
Registry status
Phase 4
Development phase
597 participants
Enrollment target

Study Summary

The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.

Interventions

  • PROCEDURE retropubic mid-urethral sling (TVT)
  • PROCEDURE transobturator mid-urethral sling (TVT-O and the Monarc)

Trial Details

FieldValue
Enrollment Target 597 participants
Start Date 2006-04
Est. Completion 2013-06
Phase Phase 4

Sponsor

Carelon Research

50 total trials

What the Registry Record Tells You About NCT00325039

The ClinicalTrials.gov registry entry for NCT00325039 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which retropubic mid-urethral sling (TVT) is the first listed.

NCT00325039 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00325039 about?

NCT00325039 is a clinical study titled "TOMUS-Trial Of Mid-Urethral Slings". The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical pro...

What is the current status of trial NCT00325039?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 597 participants. The study started on 2006-04. Estimated completion is 2013-06.

What interventions are being tested in trial NCT00325039?

The interventions under investigation include: retropubic mid-urethral sling (TVT) (PROCEDURE), transobturator mid-urethral sling (TVT-O and the Monarc) (PROCEDURE).

Who is sponsoring clinical trial NCT00325039?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.