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Vaginal ProlapsePhase 4NCT00566917

Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

A Phase 4 study testing Anterior colporrhaphy and Anterior PROLIFT in people with Vaginal Prolapse, run by Karolinska Institutet at 53 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
Vaginal Prolapse
What is being tested?
Anterior colporrhaphy and Anterior PROLIFT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
53 sitesin 4 countries
Study dates
Dec 2007to Jan 2010
Phase
Phase 4
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

53 sites in 4 countries.

53 sites in 4 countries

Sweden27 sites

  • Borås Hospital

    Borås

  • Höglandssjukhuset

    Eksjö

  • Sahlgrenska Hospital

    Gothenburg

  • Halmstad Hospital

    Halmstad

  • Huddiksvall Hospital

    Huddiksvall

  • Karlskoga Hospital

    Karlskoga

  • Karlskrona Hospital

    Karlskrona

  • Karlstad Hospital

    Karlstad

  • Kristiansstad Hospital

    Kristiansstad

  • Linköping University Hospital

    Linköping

  • Sunderby Hospital

    Luleå

  • Vrinnevi Hospital

    Norrköping

  • Capio Läkargruppen Örebro

    Örebro

  • Örebro University Hospital

    Örebro

  • Skaraborg Hospital Skövde

    Skövde

  • Södertälje Hospital

    Södertälje

  • Danderyd University Hospital

    Stockholm

  • Karolinska University Hospital Huddinge

    Stockholm

  • S:t Göran Hospital

    Stockholm

  • South Hospital

    Stockholm

  • Sundsvall Hospital

    Sundsvall

  • NÄL Hospital

    Trollhättan

  • Uppsala Academic Hospital

    Uppsala

  • Värnamo Hospital

    Värnamo

  • Västerås Hospital

    Västerås

  • Västervik Hospital

    Västervik

  • Ystad Hospital

    Ystad

Other trials in Sweden

Norway15 sites

  • Akershus University Hospital

    Ahus

  • Bærum Hospital

    Bærum

  • Haukeland Hospital

    Bergen

  • Innlandet Hospital

    Brumunddal

  • Sörlandet Hospital

    Flekkefjord

  • Förde Hospital

    Förde

  • Ringerike Hospital

    Hönefoss

  • Kongsberg Hospital

    Kongsberg

  • Levanger Hospital

    Levanger

  • Namsos Hospital

    Namsos

  • Rikshospitalet

    Oslo

  • Telemark Hospital

    Skien

  • Stavanger University Hospital

    Stavanger

  • The Regional Hospital in Tromsø

    Tromsø

  • St Olav Hospital

    Trondheim

Other trials in Norway

Finland9 sites

  • Hyvinkää Hospital

    Hyvinkää

  • Jorvi Hospital

    Jorvi

  • Central Finland Central Finland

    Jyväskylä

  • Central Finland Central Hospital

    Kotka

  • South Carelian Central Hospital

    Lappeenranta

  • Lohja Hospital

    Lohja

  • Porvoo Hospital

    Porvoo

  • Lapland Central Hospital

    Rovaniemi

  • 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 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.

Being tested
Anterior colporrhaphy, Anterior PROLIFT
Keywords
Vagina, Prolapse, Anterior vaginal wall prolapse
Medical subject headings
Uterine Prolapse, Prolapse

What participants receive

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

  • Anterior colporrhaphyProcedure or surgery

    Standardised colporrhaphy of the anterior vaginal wall

  • Anterior PROLIFTProcedure or surgery

    Transvaginal mesh surgery of the anterior vaginal wall

Study groups in NCT00566917
Study groupRoleWhat they receive
1Active comparatorAnterior colporrhaphy (standardised)
Receives: Procedure: Anterior colporrhaphy
2ExperimentalAnterior PROLIFT
Receives: Procedure: Anterior PROLIFT

What is being measured

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

  1. Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom

    Measured: One year

Secondary outcomes (1)

  1. Quality of life

    Measured: One year

Timeline

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

  1. First posted4 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2009
  4. Study completionJan 2010

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00566917
Sponsor's protocol ID
TVM III-07
Status last verified
May 2008
First submitted
30 Nov 2007
Last updated
29 Jan 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Christmann-Schmid C, Baessler K, Yeung E, Haya N, Mowat A, Chen Z, Wallace SA, Maher C. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2026 Apr 24;4(4):CD004014. doi: 10.1002/14651858.CD004014.pub7.

    PubMed 42029168

  • Baessler K, Christmann-Schmid C, Haya N, Mowat A, Chen Z, Wallace SA, Yeung E, Maher C. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev. 2026 Feb 6;2(2):CD013108. doi: 10.1002/14651858.CD013108.pub2.

    PubMed 41649019

  • Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024 Mar 13;3(3):CD012079. doi: 10.1002/14651858.CD012079.pub2.

    PubMed 38477494

  • Simone CB 2nd, Serebrenik AA, Gore EM, Mohindra P, Brown SL, Wang D, Chetty IJ, Vujaskovic Z, Menon S, Thompson J, Fine G, Kaytor MD, Movsas B. Multicenter Phase 1b/2a Clinical Trial of Radioprotectant BIO 300 Oral Suspension for Patients With Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):404-414. doi: 10.1016/j.ijrobp.2023.08.048. Epub 2023 Aug 29.

    PubMed 37652301

  • 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, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521.

    PubMed 21561348

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anterior colporrhaphy and Anterior PROLIFT in people with Vaginal Prolapse, run by Karolinska Institutet at 53 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 7 inclusion and 5 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 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom (time frame: One 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 NCT00566917, which also lists 6 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 29 Jan 2010.

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