Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse

Study Overview
=================
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.

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

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Procedure: Anterior colporrhaphy
* Procedure: Anterior PROLIFT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anterior colporrhaphy (standardised) | Procedure: Anterior colporrhaphy<br>* Standardised colporrhaphy of the anterior vaginal wall<br>|
| Experimental: 2<br>Anterior PROLIFT | Procedure: Anterior PROLIFT<br>* Transvaginal mesh surgery of the anterior vaginal wall<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vagina, Prolapse, Anterior vaginal wall prolapse