Lower Urinary Tract Symptoms Clinical Trial
Official title:
Comparison of the Tunneling or Non-tunneling During Minimally Invasive Sacrocolpopexy in Terms of Lower Urinary Tract and Bowel Symptoms.
Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the
vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic
organ prolapse and serves as the criterion standard against which other operations are
compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior
longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000
surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal
sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is
known about safety and long-term effectiveness.
Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on
lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with
laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for
pelvic organ prolapse.
Pelvic organ prolapse represents a common female pelvic floor disorder that increases with
age and has a serious impact on quality of life. It is estimated that 30% of women aged 50-89
years will seek consultation for pelvic floor disorders. The purpose of any surgical repair
of pelvic organ prolapse is to restore pelvic anatomy, preserving urinary, intestinal, and
sexual function, with the lowest rate of recurrences and complications.
In the history of surgical repair for pelvic organ prolapse vaginal or abdominal approach has
been performed. In spite of decreased morbidity and shorter hospitalisation advantage with
vaginal procedures, they have consistently lower long-term success rates compared to
abdominal sacrocolpopexy. In contrast, the abdominal approach is considered the gold standard
for surgical correction of vaginal vault prolapse, with reported long-term efficacy rates.
However, the associated morbidity of open laparotomy has made this procedure less favourable.
In an effort to overcome these drawbacks, a minimally invasive laparoscopic approach has been
adopted. However, the rigidity of the laparoscopic instrumentation makes intracorporeal
suturing and dissection in the narrow pelvis challenging. Robot-assisted technology, with its
stereoscopic vision and the use of instruments which easily moved by wrist movement, offers
an ergonomic platform that simplifies complex laparoscopic tasks and has been widely adopted
by pelvic surgeons.
Most complications following sacrocolpopexy can occur with either an open or a minimally
invasive approach, typically at similar rates. Bladder injury, postoperative voiding
dysfunction and lower urinary tract symptoms may occur. Lower urinary tract symptoms may
develop postoperatively for reason that are still not clearly understood. De nova lower
urinary tract symptoms may appear after laparoscopic or robot-assisted sacrocolpopexy with a
range from 0% to 27%. As with urinary system complication, bowel complications (bowel injury,
bowel dysfunction) may occur intraoperatively and postoperatively. Constipation is the mostly
reported with a range from 0% to 19%. Retroperitonealization of the mesh used in laparoscopic
sacrocolpopexy or robot-assisted sacrocolpopexy is thought to reduce the risk of bowel
injury, although some authors have noted a lack of bowel injuries when the mesh was left
exposed to the peritoneum.
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