Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

Karolinska Institutet (Other)
Overall Status
Completed ID
The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet. (Other), The Swedish Society of Medicine (Other), Investigators meetings supported by Gynecare Scandinavia. (Other)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anterior colporrhaphy
  • Procedure: Anterior PROLIFT
Phase 4

Study Design

Study Type:
Actual Enrollment :
400 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Quality of life [One year]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Nyköbing Hospital Nyköbing Denmark
2 Skejby Hospital Skejby Denmark
3 Hyvinkää Hospital Hyvinkää Finland
4 Jorvi Hospital Jorvi Finland
5 Central Finland Central Finland Jyväskylä Finland
6 Central Finland Central Hospital Kotka Finland
7 South Carelian Central Hospital Lappeenranta Finland
8 Lohja Hospital Lojo Finland
9 Porvoo Hospital Porvoo Finland
10 Lapland Central Hospital Rovaniemi Finland
11 Åbo Hospital Åbo Finland
12 Akershus University Hospital Ahus Norway
13 Haukeland Hospital Bergen Norway
14 Innlandet Hospital Brumunddal Norway
15 Bærum Hospital Bærum Norway
16 Sörlandet Hospital Flekkefjord Norway
17 Förde Hospital Förde Norway
18 Ringerike Hospital Hönefoss Norway
19 Kongsberg Hospital Kongsberg Norway
20 Levanger Hospital Levanger Norway
21 Namsos Hospital Namsos Norway
22 Rikshospitalet Oslo Norway
23 Telemark Hospital Skien Norway
24 Stavanger University Hospital Stavanger Norway
25 The Regional Hospital in Tromsø Tromsø Norway
26 St Olav Hospital Trondheim Norway
27 Borås Hospital Borås Sweden
28 Höglandssjukhuset Eksjö Sweden
29 Sahlgrenska Hospital Gothenburg Sweden
30 Halmstad Hospital Halmstad Sweden
31 Huddiksvall Hospital Huddiksvall Sweden
32 Karlskoga Hospital Karlskoga Sweden
33 Karlskrona Hospital Karlskrona Sweden
34 Karlstad Hospital Karlstad Sweden
35 Kristiansstad Hospital Kristiansstad Sweden
36 Linköping University Hospital Linköping Sweden
37 Sunderby Hospital Luleå Sweden
38 Vrinnevi Hospital Norrköping Sweden
39 Skaraborg Hospital Skövde Skövde Sweden
40 Danderyd University Hospital Stockholm Sweden
41 Karolinska University Hospital Huddinge Stockholm Sweden
42 S:t Göran Hospital Stockholm Sweden
43 South Hospital Stockholm Sweden
44 Sundsvall Hospital Sundsvall Sweden
45 Södertälje Hospital Södertälje Sweden
46 NÄL Hospital Trollhättan Sweden
47 Uppsala Academic Hospital Uppsala Sweden
48 Värnamo Hospital Värnamo Sweden
49 Västervik Hospital Västervik Sweden
50 Västerås Hospital Västerås Sweden
51 Ystad Hospital Ystad Sweden
52 Capio Läkargruppen Örebro Örebro Sweden
53 Örebro University Hospital Örebro Sweden

Sponsors and Collaborators

  • Karolinska Institutet
  • The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.
  • The Swedish Society of Medicine
  • Investigators meetings supported by Gynecare Scandinavia.


  • 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 Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
, , Identifier:
Other Study ID Numbers:
  • TVM III-07
First Posted:
Dec 4, 2007
Last Update Posted:
Jan 29, 2010
Last Verified:
May 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2010