Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

April 11, 2017 updated by: Mariella Withagen, Radboud University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.

An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuizen
      • Arnhem, Netherlands
        • Slysis Zorggroep, location Rijnstate
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Gouda, Netherlands
        • Groene Hart Ziekenhuis
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • UMC St Radboud
      • Rotterdam, Netherlands
        • Ikazia
      • Stadskanaal, Netherlands
        • Refaja
      • Tilburg, Netherlands
        • Twee Steden Ziekenhuis
      • Tilburg, Netherlands
        • St. Elisabeth Hospital
      • Zaandam, Netherlands
        • Zaans Medisch Centrum
      • Zwolle, Netherlands
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
  • patient has agreed to undergo implantation of TVM (prolift) or fascial plication
  • patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
  • patient is willing to complete quality of life questionnaires at 6 and 12 months

Exclusion Criteria:

  • patient is or wants to become pregnant
  • patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
  • patient has current urinary tract or vaginal infections
  • patient has a blood coagulation disorder
  • patient has a compromised immune system or any other condition that would compromise healing
  • patient has renal insufficiency and/or upper urinary tract obstruction
  • patient is unwilling or unable to return for evaluation
  • patient has had previous irradiation
  • patient has any malignancy
  • patient has large ovarian cysts of large myoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesh surgery
Trocar guided tension free vaginal mesh insertion by Prolift mesh kit
Device: Tensionfree vaginal mesh kit (Prolift)
Insertion of a tension free vaginal mesh using a Prolift mesh kit
Other Names:
  • Prolift mesh
Active Comparator: Conventional vaginal surgery
Classical vaginal prolapse surgery (fascia plication)
Procedure: classic vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Other Names:
  • Conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
Time Frame: 12 months
Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesh Exposure at 12 Months
Time Frame: 12 months
cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)
12 months
"Patient Global Impression of Improvement" (PGI-I) at 12 Months
Time Frame: at 12 months
Number of participants with much to very much improvement compared to baseline
at 12 months
Bulge Symptoms
Time Frame: 12 months

Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months.

Scores range from 0 (least/no bother) to 100 (maximum bother)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Mariella ij Withagen, Drs., UMC St Radboud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (Estimate)

September 6, 2006

Study Record Updates

Last Update Posted (Actual)

July 3, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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