Anterior Pelvic Organ Prolapse Clinical Trial
Official title:
Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An
"anterior wall prolapse" occurs when the front of the vagina loses its support, and the
bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out
of the vagina.
One of the treatment options available is to repair the anterior wall surgically. The goals
of surgery are to return the anatomy to its usual position, ensuring that all the pelvic
floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair
would also be long lasting.
Two surgical options are routinely performed in Calgary for repair of an anterior
compartment prolapse. One option involves fixing the organs back in place using sutures. The
other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is
already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in
the pelvic area. The investigators do not know which of these two options is the best
surgical procedure. Both may have different advantages that would result in better results.
This study is designed to try and find out if one of these procedures is better, and if a
larger study may be needed.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment