At a glance

ClinicalIndex Comparison Record

N/ACompleted· 194 enrolled

Drug / intervention

Tensionfree vaginal mesh kit (Prolift) +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00372190

NCT00372190N/ACompleted

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A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse

Radboud University Medical Center·interventional·Posted Sep 6, 2006·Updated Jul 3, 2017

In Brief

A clinical study evaluating Tensionfree vaginal mesh kit (Prolift) and classic vaginal prolapse surgery (fascia plication) for Pelvic Organ Prolapse. Completed, enrolled 194 participants across 13 sites.

Detailed Summary

Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications. This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPelvic Organ Prolapse

CountriesNetherlands

Collaborators--

Timeline

N/ACompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2006

First PostedSep 2006

Primary CompletionDec 2009

Study CompletionDec 2015

TodayJul 2026

First PostedSep 6, 2006

Enrollment StartAug 1, 2006

Primary CompletionDec 1, 2009

Study CompletionDec 1, 2015

TodayJul 2, 2026

Enrollment to primary: 3.3 yearsPosted 19.8 years ago

Interventions

Tensionfree vaginal mesh kit (Prolift)device

Insertion of a tension free vaginal mesh using a Prolift mesh kit

classic vaginal prolapse surgery (fascia plication)procedure

classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse