Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse
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|ClinicalTrials.gov Identifier: NCT00566917|
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : January 29, 2010
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
Active Comparator: 1
Anterior colporrhaphy (standardised)
Procedure: Anterior colporrhaphy
Standardised colporrhaphy of the anterior vaginal wall
Procedure: Anterior PROLIFT
Transvaginal mesh surgery of the anterior vaginal wall
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566917
|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|