Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
Condition: Post Operative Pain; Complication of Surgical Procedure
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Pelvic organ prolapse is an herniation process, needing a mesh reconstruction for long
      lasting therapeutic effect. Yet, mesh implants were reported to be related to severe adverse
      effects. This study looks at the potential benefit of mesh size reduction regarding avoiding
      operative complications.
    

Detailed description: 
      Pelvic organ prolapse is a common disorder that results in significant patient morbidity.
      Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP)
      and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP
      remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani
      (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during
      childbirth trauma.

      It is evident that pelvic organ prolapse (POP) occurs when the supporting pelvic floor
      becomes weakened or stretched, usually caused by childbirth, leading to descent of the pelvic
      organs to the vagina and beyond. This contributes to the impairment of pelvic organ function
      and a deterioration of patient quality of life. POP is estimated to severely affect
      approximately 11% of the female population.

      Symptomatic POP patients might benefit from conservative management, such as the use of
      physiotherapy or vaginal pessaries. However, advanced POP necessitates surgical
      reconstruction. This might be achieved by the abdominal approach by an open operation or by
      laparoscopy, or by the vaginal approach. Synthetic permanent or absorbable meshes or
      biological grafts, or any synthesis of these might be used for reinforcement of the weakened
      pelvic floor structures that led to POP.

      The need for reinforcement of the weakened fascia for achieving a long lasting cure of
      herniation processes is un-questionable. Given that the underlying pathology leading to POP
      is actually just a hernia of the pelvic floor, one must admit that the very same surgical
      principles used for any hernia repair are applicable for POP.

      Most of the adverse effects are related to excessive implanted mesh mass. Thus, our goal with
      this study is to look at the issue of reducing the mesh size, surface area and the total mesh
      mass, assuming that the less quantity of left over implant the less mesh related complication
      will occur. The narrative for that is the notion that the natural pelvic floor connective
      tissue architecture is ligamentary and not "sheath like", while available pre-cut meshes are
      much too wide spread. This study concept is that reducing the mesh surface will lead to
      reduction with the mesh related complication. Given that the mesh implant size will be
      reduced, so will also be the wide of the extent of preliminary dissection, necessary for
      proper mesh placement. Thus, the dissection related adverse effects are expected to reduce as
      well.
    

Intervention name(s): reduced mesh implants
Intervention type(s): Other
Intervention description(s): mesh for pelvic floor reinforcement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic floor reconstruction; mesh implants