Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse
A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse
1 other identifier
interventional
400
4 countries
53
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2007
Typical duration for phase_4
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJanuary 29, 2010
May 1, 2008
2 years
November 30, 2007
January 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom
One year
Secondary Outcomes (1)
Quality of life
One year
Study Arms (2)
1
ACTIVE COMPARATORAnterior colporrhaphy (standardised)
2
EXPERIMENTALAnterior PROLIFT
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Nyköbing Hospital
Nyköbing, Denmark
Skejby Hospital
Skejby, Denmark
Hyvinkää Hospital
Hyvinkää, Finland
Jorvi Hospital
Jorvi, Finland
Central Finland Central Finland
Jyväskylä, Finland
Central Finland Central Hospital
Kotka, Finland
South Carelian Central Hospital
Lappeenranta, Finland
Lohja Hospital
Lohja, Finland
Porvoo Hospital
Porvoo, Finland
Lapland Central Hospital
Rovaniemi, Finland
Åbo Hospital
Turku, Finland
Akershus University Hospital
Ahus, Norway
Haukeland Hospital
Bergen, Norway
Innlandet Hospital
Brumunddal, Norway
Bærum Hospital
Bærum, Norway
Sörlandet Hospital
Flekkefjord, Norway
Förde Hospital
Förde, Norway
Ringerike Hospital
Hönefoss, Norway
Kongsberg Hospital
Kongsberg, Norway
Levanger Hospital
Levanger, Norway
Namsos Hospital
Namsos, Norway
Rikshospitalet
Oslo, Norway
Telemark Hospital
Skien, Norway
Stavanger University Hospital
Stavanger, Norway
The Regional Hospital in Tromsø
Tromsø, Norway
St Olav Hospital
Trondheim, Norway
Borås Hospital
Borås, Sweden
Höglandssjukhuset
Eksjö, Sweden
Sahlgrenska Hospital
Gothenburg, Sweden
Halmstad Hospital
Halmstad, Sweden
Huddiksvall Hospital
Huddiksvall, Sweden
Karlskoga Hospital
Karlskoga, Sweden
Karlskrona Hospital
Karlskrona, Sweden
Karlstad Hospital
Karlstad, Sweden
Kristiansstad Hospital
Kristiansstad, Sweden
Linköping University Hospital
Linköping, Sweden
Sunderby Hospital
Luleå, Sweden
Vrinnevi Hospital
Norrköping, Sweden
Capio Läkargruppen Örebro
Örebro, Sweden
Örebro University Hospital
Örebro, Sweden
Skaraborg Hospital Skövde
Skövde, Sweden
Södertälje Hospital
Södertälje, Sweden
Danderyd University Hospital
Stockholm, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
S:t Göran Hospital
Stockholm, Sweden
South Hospital
Stockholm, Sweden
Sundsvall Hospital
Sundsvall, Sweden
NÄL Hospital
Trollhättan, Sweden
Uppsala Academic Hospital
Uppsala, Sweden
Värnamo Hospital
Värnamo, Sweden
Västerås Hospital
Västerås, Sweden
Västervik Hospital
Västervik, Sweden
Ystad Hospital
Ystad, Sweden
Related Publications (3)
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.
PMID: 38477494DERIVEDElmer 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.
PMID: 22517125DERIVEDAltman 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.
PMID: 21561348DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 4, 2007
Study Start
December 1, 2007
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
January 29, 2010
Record last verified: 2008-05