Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

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.

Conditions

• Vaginal Prolapse

Interventions

PROCEDURE

Anterior colporrhaphy

Standardised colporrhaphy of the anterior vaginal wall

PROCEDURE

Anterior PROLIFT

Transvaginal mesh surgery of the anterior vaginal wall

Sponsors & Collaborators

• The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.

  collaborator UNKNOWN

• The Swedish Society of Medicine

  collaborator OTHER

• Investigators meetings supported by Gynecare Scandinavia.

  collaborator UNKNOWN

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Daniel Altman, MD, Assoc. prof. · Karolinska Institutet

• Christian Falconer, MD, Assoc. prof. · Karolinska Institutet at Danderyd University Hospital

• Daniel Altman, MD, Assoc. prof. · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2009-12-31

Completion

2010-01-31

Countries

• Denmark
• Finland
• Norway
• Sweden

Study Locations