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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Borås 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 Skovde
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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