Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

November 13, 2007 updated by: Karolinska Institutet

A Multicenter Clinical Safety Assessment of Polypropylene Transvaginal Mesh in Pelvic Reconstructive Surgery

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.

The notion of reinforcing pelvic floor defects using biomaterial implants is not an exclusively contemporary idea. Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials as support with varying success. 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. However, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques.

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. Already commercially available implant materials are in need of patient safety documentation, both when considering the surgical techniques by which these materials are placed in the body as well as the actual materials. Complication rates and perioperative morbidity using these surgical routes in pelvic organ prolapse surgery are generally unknown.

The aim of the present study was to assess the long term morbidity, and describe the complications, associated with transvaginal mesh repair of pelvic organ prolapse using the PROLIFT®-system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Main objective:

- To describe short and long-term complications associated with pelvic organ prolapse repair using macroporous polypropylene transvaginal mesh (TVM) using a transobturator or transgluteal approach.

Secondary objectives:

  • To describe anatomical restoration of the pelvic floor following transvaginal mesh repair of pelvic organ prolapse using the Pelvic Organ Prolapse Quantification system (POP-Q).
  • To describe subjective patient outcomes using validated questionnaires with regard to pelvic organ function (UDI), sexual function (PISQ) and quality of life (IIQ).

Study design:

- A prospective multicenter open labeled single cohort study.

Study protocol:

  • At baseline patients receive oral and written information about the study.
  • Following informed consent, patients are included in the study if pelvic organ prolapse surgery is indicated and all inclusion, and no exclusion, criteria are fulfilled.
  • Preoperatively all patients answer a detailed self reported questionnaire on health history, previous surgery, obstetrical history and current diseases and medications. The questionnaire also includes questions on symptoms from the pelvic organs and pelvic floor.
  • Preoperatively all patients undergo a clinical examination using the POP-Q system, as well as, a validated clinical inflammatory grading of the vaginal compartments.
  • Patients undergo the TVM procedure in a standardised manner with all participating surgeons having undergone pretrial surgical training and adopting the same surgical technique. All patients receive standardised intraoperative antibiotics.
  • Complications during the immediate peri- and postoperative hospital stay are registered in hospital charts.
  • All patients receive a clinical follow-up appointment 2 months, 1 year and 3 years after surgery. At follow-up identical self reported questionnaires are used for subjective assessment. Clinical examinations are performed as preoperatively suing the POP-Q system and macroscopic inflammatory grading. Complications are registered in a specific protocol and hospital charts.
  • All protocols are to be submitted after the 2 months follow-up for an interrim safety analysis. The study chair is responsible for stopping the study if the rate, or seriousness, of complications exceed the expected.
  • Patients are free to withdraw from the study at any point.

Study Type

Interventional

Enrollment

250

Phase

  • Phase 2
  • Phase 3

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
      • Jorvi, Finland
        • Jorvi Hospital
      • Lahti, Finland
        • Lahti Hospital
      • Lojo, Finland
        • Lojo Hospital
      • Åbo, Finland
        • Åbo Hospital
  • Norway
      • Ahus, Norway
        • Akershus University Hospital
      • Bergen, Norway
        • Haukeland Hospital
      • Bærum, Norway
        • Bærum Hospital
      • Gjøvik, Norway
        • Gjøvik Hospital
      • Kongsberg, Norway
        • Kongsberg Hospital
      • Oslo, Norway
        • Rikshospitalet
      • Tromsø, Norway
        • The Regional Hospital in Tromsø
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska Hospital
      • Halmstad, Sweden
        • Halmstad Hospital
      • Kristiansstad, Sweden
        • Kristiansstad Hospital
      • Linköping, Sweden
        • Linköping University Hospital
      • Norrköping, Sweden
        • Vrinnevi Hospital
      • Skövde, Sweden
        • Skaraborg Hospital Skovde
      • Stockholm, Sweden
        • S:t Göran Hospital
      • Stockholm, Sweden
        • Danderyd University Hospital
      • Stockholm, Sweden
        • South Hospital
      • Uppsala, Sweden
        • Uppsala Academic Hospital
      • Västerås, Sweden
        • Västerås Hospital
      • Ystad, Sweden
        • Ystad Hospital
      • Örebro, Sweden
        • Örebro University Hospital

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:

  • Pelvic organ prolapse stage 2 or more according to the POP-Q staging system
  • Symptoms related to pelvic organ prolapse including bulging, pelvic heaviness and vaginal protrusion
  • Able to make an informed consent to participate
  • Physically and mentally able to participate in follow-up

Exclusion Criteria:

  • Previous pelvic organ cancer regardless of treatment
  • Severe rheumatic disease requiring per oral steroid treatment
  • Systemic connective tissue disorder (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
  • Physically or mentally unable to participate in follow-up or give informed consent to participate in the study

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immediate and delayed TVM-related complications.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Anatomical outcome using the validated POP-Q staging system.
Time Frame: 1 year
1 year
Subjective outcome using the validated UDI, IIQ and PISQ.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

Investigators

  • Study Chair: Daniel Altman, MD, PhD, Karolinska Institutet, Stockholm, Sweden

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

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 13, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVM-II-2006

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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