Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

Phase 4

Completed

• Conditions: Vaginal Prolapse
• Interventions: Procedure: Anterior colporrhaphy; Procedure: Anterior PROLIFT

• Registration Number: NCT00566917
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study Start: 2007-12
• Study First Posted: 2007-12-04
• Status Verified: 2008-05
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-28
• Last Update Posted: 2010-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anterior colporrhaphy	Anterior colporrhaphy (standardised)
2	Anterior PROLIFT	Anterior PROLIFT

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life	One year

Trial Locations

Locations (53)

Hyvinkää Hospital; 🇫🇮 Hyvinkää, Finland

Central Finland Central Finland; 🇫🇮 Jyväskylä, Finland

Lapland Central Hospital; 🇫🇮 Rovaniemi, Finland

St Olav Hospital; 🇳🇴 Trondheim, Norway

Nyköbing Hospital; 🇩🇰 Nyköbing, Denmark

Jorvi Hospital; 🇫🇮 Jorvi, Finland

Central Finland Central Hospital; 🇫🇮 Kotka, Finland

Skejby Hospital; 🇩🇰 Skejby, Denmark

South Carelian Central Hospital; 🇫🇮 Lappeenranta, Finland

Lohja Hospital; 🇫🇮 Lojo, Finland

Åbo Hospital; 🇫🇮 Åbo, Finland

Porvoo Hospital; 🇫🇮 Porvoo, Finland

Haukeland Hospital; 🇳🇴 Bergen, Norway

Innlandet Hospital; 🇳🇴 Brumunddal, Norway

Akershus University Hospital; 🇳🇴 Ahus, Norway

Sörlandet Hospital; 🇳🇴 Flekkefjord, Norway

Bærum Hospital; 🇳🇴 Bærum, Norway

Förde Hospital; 🇳🇴 Förde, Norway

Kongsberg Hospital; 🇳🇴 Kongsberg, Norway

Namsos Hospital; 🇳🇴 Namsos, Norway

Ringerike Hospital; 🇳🇴 Hönefoss, Norway

Levanger Hospital; 🇳🇴 Levanger, Norway

Telemark Hospital; 🇳🇴 Skien, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

The Regional Hospital in Tromsø; 🇳🇴 Tromsø, Norway

Rikshospitalet; 🇳🇴 Oslo, Norway

Borås Hospital; 🇸🇪 Borås, Sweden

Höglandssjukhuset; 🇸🇪 Eksjö, Sweden

Sahlgrenska Hospital; 🇸🇪 Gothenburg, Sweden

Karlskoga Hospital; 🇸🇪 Karlskoga, Sweden

Karlskrona Hospital; 🇸🇪 Karlskrona, Sweden

Halmstad Hospital; 🇸🇪 Halmstad, Sweden

NÄL Hospital; 🇸🇪 Trollhättan, Sweden

Kristiansstad Hospital; 🇸🇪 Kristiansstad, Sweden

Huddiksvall Hospital; 🇸🇪 Huddiksvall, Sweden

Karlstad Hospital; 🇸🇪 Karlstad, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Sunderby Hospital; 🇸🇪 Luleå, Sweden

Vrinnevi Hospital; 🇸🇪 Norrköping, Sweden

Skaraborg Hospital Skövde; 🇸🇪 Skövde, 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

Södertälje Hospital; 🇸🇪 Södertälje, Sweden

Uppsala Academic Hospital; 🇸🇪 Uppsala, Sweden

Värnamo Hospital; 🇸🇪 Värnamo, Sweden

Västervik Hospital; 🇸🇪 Västervik, Sweden

Västerås Hospital; 🇸🇪 Västerås, Sweden

Ystad Hospital; 🇸🇪 Ystad, Sweden

Capio Läkargruppen Örebro; 🇸🇪 Örebro, Sweden

Örebro University Hospital; 🇸🇪 Örebro, Sweden