Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

Vaginal Prolapse Clinical Trial

Official title:

A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566917
• Other study ID #: TVM III-07
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2007
• Last updated: January 28, 2010
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: May 2008
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prolapse
• Vaginal Prolapse

Intervention

Procedure:
• Anterior colporrhaphy
Standardised colporrhaphy of the anterior vaginal wall
• Anterior PROLIFT
Transvaginal mesh surgery of the anterior vaginal wall

Locations

Country	Name	City	State
Denmark	Nyköbing Hospital	Nyköbing
Denmark	Skejby Hospital	Skejby
Finland	Åbo Hospital	Åbo
Finland	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	Lojo
Finland	Porvoo Hospital	Porvoo
Finland	Lapland Central Hospital	Rovaniemi
Norway	Akershus University Hospital	Ahus
Norway	Bærum Hospital	Bærum
Norway	Haukeland Hospital	Bergen
Norway	Innlandet Hospital	Brumunddal
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
Sweden	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

Sponsors (4)

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

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom		One year	No
Secondary	Quality of life		One year	No