This research protocol is a randomized controlled trial. It is being done to compare and
find out the relative differences between the materials, (Pelivisoft) "natural organic mesh"
to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy.
This surgery involves supporting the prolapsed vaginal wall with a piece of material (known
as a graft) attached to a ligament along your backbone (or sacrum). These materials are
both FDA approved and widely used. The following objectives: anatomic outcomes,
graft-related complications between the two materials, changes in pelvic organ
prolapse-related quality of life, subjective changes in sexual function,changes in bowel
function and the prolapse related pain present after sacral colpopexy will be evaluated.
The study visits are all under standard of care. Study questionnaires are unique to the
study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and
one year visits The questionnaires are related to bowel function, bladder function,
prolapse and sexual activity.
Permission will be requested to contact the patient again 5 years after surgery. Contact
in the future will in no way obligate the patient to participate.
There may or may not be direct medical benefits to the participant. Decreased risk of
erosion may be a possible benefit if placed in the organic "natural" arm of the study. The
information learned from this study may benefit other patients in the future
- Greater than 18 years of age
- Prior sacral colpopexy or rectopexy
Contraindication to surgery based on co-existent medical condition
Desire for expectant management or pessary use
Pregnancy or the desire for pregnancy within 24 months of the sacral colpopexy procedure