Post Operative Pain Clinical Trial
Official title:
Phase 2-3 Study of Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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