Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse
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.


Options:
A: Arm Label: Anterior Colporrhaphy (sutured repair); Type: PLACEBO_COMPARATOR; Interventions: Procedure: sutured anterior vaginal prolapse repair | Arm Label: Perigee (grafted repair); Type: ACTIVE_COMPARATOR; Interventions: Device: grafted anterior prolapse repair | Intervention Type: DEVICE; Name: grafted anterior prolapse repair; Assigned to Arm(s): Perigee (grafted repair) | Intervention Type: PROCEDURE; Name: sutured anterior vaginal prolapse repair; Assigned to Arm(s): Anterior Colporrhaphy (sutured repair)
B: Arm Label: SIS Mesh (Cook Medical); Type: EXPERIMENTAL; Interventions: Device: SIS mesh (Cook Medical), Procedure: Anterior prolapse repair | Arm Label: No-mesh; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Anterior prolapse repair | Intervention Type: DEVICE; Name: SIS mesh (Cook Medical); Assigned to Arm(s): SIS Mesh (Cook Medical) | Intervention Type: PROCEDURE; Name: Anterior prolapse repair; Assigned to Arm(s): No-mesh, SIS Mesh (Cook Medical)
C: Arm Label: Prolift mesh; Type: ACTIVE_COMPARATOR; Interventions: Device: synthetic monofilament polypropylene mesh | Arm Label: Prolapse repair without mesh; Type: ACTIVE_COMPARATOR; Interventions: Device: synthetic monofilament polypropylene mesh | Intervention Type: DEVICE; Name: synthetic monofilament polypropylene mesh; Assigned to Arm(s): Prolapse repair without mesh, Prolift mesh
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Anterior colporrhaphy | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Procedure: Anterior PROLIFT | Intervention Type: PROCEDURE; Name: Anterior colporrhaphy; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Anterior PROLIFT; Assigned to Arm(s): 2

Answer: D