Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

January 28, 2010 updated by: Karolinska Institutet

A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse

Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For decades, suture repair techniques have been the primary choice of surgical treatment when indicated.

Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and it is plausible that inherently weak, or damaged, pelvic floor supportive tissues need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques. Over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials with varying success. Despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years .

It is likely that biomaterials need to be "anchored" in tissues not afflicted by the disease, in order to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques using a transobturator approach passing the mesh through the arcus tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach. Short term data from concluded and on-going safety assessments of these techniques has provided promising results and satisfying clinical outcomes. The aim of the present study is to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

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

  • Denmark
      • Nyköbing, Denmark
        • Nyköbing Hospital
      • Skejby, Denmark
        • Skejby Hospital
  • Finland
      • Hyvinkää, Finland
        • Hyvinkää Hospital
      • Jorvi, Finland
        • Jorvi Hospital
      • Jyväskylä, Finland
        • Central Finland Central Finland
      • Kotka, Finland
        • Central Finland Central Hospital
      • Lappeenranta, Finland
        • South Carelian Central Hospital
      • Lojo, Finland
        • Lohja Hospital
      • Porvoo, Finland
        • Porvoo Hospital
      • Rovaniemi, Finland
        • Lapland Central Hospital
      • Åbo, Finland
        • Åbo Hospital
  • Norway
      • Ahus, Norway
        • Akershus University Hospital
      • Bergen, Norway
        • Haukeland Hospital
      • Brumunddal, Norway
        • Innlandet Hospital
      • Bærum, Norway
        • Bærum Hospital
      • Flekkefjord, Norway
        • Sorlandet hospital
      • Förde, Norway
        • Forde Hospital
      • Hönefoss, Norway
        • Ringerike Hospital
      • Kongsberg, Norway
        • Kongsberg Hospital
      • Levanger, Norway
        • Levanger Hospital
      • Namsos, Norway
        • Namsos Hospital
      • Oslo, Norway
        • Rikshospitalet
      • Skien, Norway
        • Telemark Hospital
      • Stavanger, Norway
        • Stavanger University Hospital
      • Tromsø, Norway
        • The Regional Hospital in Tromsø
      • Trondheim, Norway
        • St Olav hospital
  • Sweden
      • Borås, Sweden
        • Boras hospital
      • Eksjö, Sweden
        • Höglandssjukhuset
      • Gothenburg, Sweden
        • Sahlgrenska Hospital
      • Halmstad, Sweden
        • Halmstad Hospital
      • Huddiksvall, Sweden
        • Huddiksvall Hospital
      • Karlskoga, Sweden
        • Karlskoga Hospital
      • Karlskrona, Sweden
        • Karlskrona Hospital
      • Karlstad, Sweden
        • Karlstad Hospital
      • Kristiansstad, Sweden
        • Kristiansstad Hospital
      • Linköping, Sweden
        • Linkoping University Hospital
      • Luleå, Sweden
        • Sunderby Hospital
      • Norrköping, Sweden
        • Vrinnevi Hospital
      • Skövde, Sweden
        • Skaraborg hospital Skövde
      • Stockholm, Sweden
        • S:t Göran Hospital
      • Stockholm, Sweden
        • Danderyd University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital Huddinge
      • Stockholm, Sweden
        • South Hospital
      • Sundsvall, Sweden
        • Sundsvall Hospital
      • Södertälje, Sweden
        • Södertälje Hospital
      • Trollhättan, Sweden
        • NÄL Hospital
      • Uppsala, Sweden
        • Uppsala Academic Hospital
      • Värnamo, Sweden
        • Värnamo Hospital
      • Västervik, Sweden
        • Västervik Hospital
      • Västerås, Sweden
        • Västerås hospital
      • Ystad, Sweden
        • Ystad Hospital
      • Örebro, Sweden
        • Orebro University Hospital
      • Örebro, Sweden
        • Capio Läkargruppen Örebro

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:

  • Reproductive years in the past (biologically or reproductive decision)
  • Prolapse of the anterior vaginal wall ≥POPQ-stadium II
  • Prolapse specific pelvic symptom
  • Being able to make an informed consent on participation
  • Physically and cognitive capable of participating in the required follow-up
  • No other pelvic floor surgery performed at the time of anterior repair
  • No exclusion criteria fulfilled

Exclusion Criteria:

  • Previous or current pelvic organ cancer (regardless of treatment)
  • Severe rheumatic disease
  • Insulin treated diabetes mellitus
  • Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis eller rheumatic myalgia)
  • Current systemic steroid treatment

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Anterior colporrhaphy (standardised)
Procedure: Anterior colporrhaphy
Standardised colporrhaphy of the anterior vaginal wall
Experimental: 2
Anterior PROLIFT
Procedure: Anterior PROLIFT
Transvaginal mesh surgery of the anterior vaginal wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

The Swedish Society of Medicine
The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.
Investigators meetings supported by Gynecare Scandinavia.

Investigators

  • Study Chair: Daniel Altman, MD, Assoc. prof., Karolinska Institutet
  • Study Director: Christian Falconer, MD, Assoc. prof., Karolinska Institutet at Danderyd University Hospital
  • Principal Investigator: Daniel Altman, MD, Assoc. prof., Karolinska Institutet

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

December 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 29, 2010

Last Update Submitted That Met QC Criteria

January 28, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVM III-07

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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