Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT00566917

Collaborator

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)

400

Enrollment

Locations

Arms

Duration (Months)

7.5

Patients Per Site

0.3

Patients Per Site Per Month

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
Vaginal Prolapse	Procedure: Anterior colporrhaphy Procedure: Anterior PROLIFT	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

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

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

Secondary Outcome Measures

Quality of life [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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

Locations

	Site	City	Country
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.

Investigators

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