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Pelvic Organ ProlapsePhase 2/3NCT00402844

Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh

A Phase 2/3 study testing Transvaginal mesh- PROLIFT®-system in people with Pelvic Organ Prolapse, run by Karolinska Institutet at 26 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Organ Prolapse
What is being tested?
Transvaginal mesh- PROLIFT®-system
Type of treatment
Medical device
How many people
250 participants
Where
26 sitesin 4 countries
Study dates
Aug 2006to Mar 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

26 sites in 4 countries.

26 sites in 4 countries

Sweden13 sites

  • Sahlgrenska Hospital

    Gothenburg

  • Halmstad Hospital

    Halmstad

  • Kristiansstad Hospital

    Kristiansstad

  • Linköping University Hospital

    Linköping

  • Vrinnevi Hospital

    Norrköping

  • Örebro University Hospital

    Örebro

  • Skaraborg Hospital Skövde

    Skövde

  • Danderyd University Hospital

    Stockholm

  • S:t Göran Hospital

    Stockholm

  • South Hospital

    Stockholm

  • Uppsala Academic Hospital

    Uppsala

  • Västerås Hospital

    Västerås

  • Ystad Hospital

    Ystad

Other trials in Sweden

Norway7 sites

  • Akershus University Hospital

    Ahus

  • Bærum Hospital

    Bærum

  • Haukeland Hospital

    Bergen

  • Gjøvik Hospital

    Gjøvik

  • Kongsberg Hospital

    Kongsberg

  • Rikshospitalet

    Oslo

  • The Regional Hospital in Tromsø

    Tromsø

Other trials in Norway

Finland4 sites

  • Jorvi Hospital

    Jorvi

  • Lahti Hospital

    Lahti

  • Lojo Hospital

    Lohja

  • Åbo Hospital

    Turku

Other trials in Finland

Denmark2 sites

  • Nyköbing Hospital

    Nyköbing

  • Skejby Hospital

    Skejby

Other trials in Denmark

About this study

Official title: 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.

Read more

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.

Read the 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.
Being tested
Transvaginal mesh- PROLIFT®-system
Keywords
Multicenter, Pelvic organ prolapse, Prospective, Transvaginal mesh
Medical subject headings
Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transvaginal mesh- PROLIFT®-systemDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate and delayed TVM-related complications.

    Measured: 1 year

Secondary outcomes (2)

  1. Anatomical outcome using the validated POP-Q staging system.

    Measured: 1 year

  2. Subjective outcome using the validated UDI, IIQ and PISQ.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startAug 2006
  3. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402844
Sponsor's protocol ID
TVM-II-2006
Status last verified
Nov 2007
First submitted
20 Nov 2006
Last updated
14 Nov 2007
Results posted
No
Data monitoring committee
No

Publications

  • Altman D, Falconer C. Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):303-8. doi: 10.1097/01.AOG.0000250970.23128.63.

    PubMed 17267828

  • Elmer C, Falconer C, Hallin A, Larsson G, Ek M, Altman D; Nordic Transvaginal Mesh Group. Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse. Neurourol Urodyn. 2012 Sep;31(7):1165-9. doi: 10.1002/nau.22231. Epub 2012 Apr 19.

    PubMed 22517125

  • Altman D, Elmer C, Kiilholma P, Kinne I, Tegerstedt G, Falconer C; Nordic Transvaginal Mesh Group. Sexual dysfunction after trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009 Jan;113(1):127-133. doi: 10.1097/AOG.0b013e3181922362.

    PubMed 19104368

  • Elmer C, Altman D, Engh ME, Axelsen S, Vayrynen T, Falconer C; Nordic Transvaginal Mesh Group. Trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009 Jan;113(1):117-126. doi: 10.1097/AOG.0b013e3181922164.

    PubMed 19104367

  • Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):787-93. doi: 10.1007/s00192-007-0526-2.

    PubMed 18074068

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Transvaginal mesh- PROLIFT®-system in people with Pelvic Organ Prolapse, run by Karolinska Institutet at 26 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Sweden, Norway, Finland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate and delayed TVM-related complications. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402844, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2007.

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