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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Standardised colporrhaphy of the anterior vaginal wall
Transvaginal mesh surgery of the anterior vaginal wall
Nyköbing Hospital
Nyköbing, Denmark
Skejby Hospital
Skejby, Denmark
Hyvinkää Hospital
Hyvinkää, Finland
Jorvi Hospital
Jorvi, Finland
Central Finland Central Finland
Jyväskylä, Finland
Central Finland Central Hospital
Kotka, Finland
Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom
Time frame: One year
Quality of life
Time frame: One year
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South Carelian Central Hospital
Lappeenranta, Finland
Lohja Hospital
Lohja, Finland
Porvoo Hospital
Porvoo, Finland
Lapland Central Hospital
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