Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03053479 |
| Other study ID # |
SAME |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2016 |
| Est. completion date |
March 2028 |
Study information
| Verified date |
February 2023 |
| Source |
Charles University, Czech Republic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very
little is known about the factors associated with surgical failure. Studies have identified a
variety of risk factors: younger age, high body mass index and advanced preoperative prolapse
(grade III-IV) have been associated with an increased risk of reoperation in some studies.
According to some studies patients had poorer anatomical outcome after traditional repairs
but were able to enjoy the same quality of life as after transvaginal mesh surgery or
laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy
of these three procedures in a randomized controlled trial.
Description:
Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. The
lifetime likelihood of undergoing at least one incident of pelvic organ prolapse surgery has
been estimated at approximately 13%. The prevalence of reoperation after primary pelvic
reconstructive surgery is high at around 30%, while some studies report the figure as up to
58%. In the early 1990s the perception of pelvic floor defects and urinary incontinence in
women started to change significantly. The diagnostics and management of these defects became
an independent uro-gynecological sub-specialization within gynaecology and obstetrics, and it
has been included among 4 basic sub-specializations recognized by the European Board and
College of Obstetrics and Gynecology. Surgical treatment is indicated in women with
symptomatic POP when conservative management has failed or has been declined. There is no
indication for repair of asymptomatic POP as an isolated procedure where surgical correction
is of uncertain benefit and adds peri- and post-operative risks. The objective of our
treatment should always aim to restore quality of life and comfort. Very little is known
about the factors associated with surgical failure. Studies have identified a variety of risk
factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV)
have been associated with an increased risk of reoperation in some studies, while other
studies did not prove these hypotheses. One factor which significantly influences the result
of the pelvic organ surgery is the presence of pelvic floor injury. Injury of the musculus
levator ani mainly affects the results of traditional vaginal wall repair, with 60% risk of
recurrence. In the last few years, in an attempt to reduce recurrence and improve the outcome
of reconstructive surgery in the treatment of pelvic organ prolapse, surgeons have started to
use transvaginally introduced prosthetic material (mesh). This type of surgery significantly
increases the efficacy of the procedure (anatomic cure rate over 90%), but its use is
associated with a risk of some complications (vaginal erosions and potential consecutive
infections, granulomas, dyspareunia, vesico-vaginal fistulas, chronic pain) thereby
potentially reducing patient quality of life and leading to additional surgery. If the mesh
is introduced during sacrocolpopexy and the vaginal wall is not open, there is a significant
decrease of mesh-related complications. Laparoscopic sacrocolpopexy is considered the gold
standard for the management of apical prolapse with high long-term efficacy. According to
some studies patients had poorer anatomical outcome after traditional repairs but were able
to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic
sacrocolpopexy. Therefore the investigators plan to assess the efficacy in a randomized trial
of three different surgical methods (the Amreich-Richter procedure, transvaginal mesh and
laparoscopic sacrocolpopexy) in patients with high risk of recurrence; i.e. patients with
advanced pelvic organ prolapse (at least stage III) and proved injury of pelvic floor
muscles.
Aims of the study: To evaluate on the basis of a prospective randomized trial the clinical
efficacy of three different surgical procedures (the Amreich-Richter procedure, transvaginal
mesh and laparoscopic sacrocolpopexy) in women with advanced pelvic organ prolapse and proved
pelvic floor muscle injury
All patients will undergo complete urogynecological investigation before the procedure
(history, clinical examination, assessment of pelvic organ prolapse using the POPQ system,
examination of the levator resting tone and contraction (Oxford scale),where appropriate
urodynamics according to ICS recommendation and ultrasound examination), and they will fill
in standardized international questionnaires (ICIQ-UI SF, PISQ 12, UDI_POPDI-CRADI, POP-SF).
Ultrasound examinations will be performed as a combined examination using a convex probe,
from abdominal and perineal approaches, and sectoral vaginal probe from the introital
approach. Investigation will be preserved mainly in digital form and partly on videotapes.
Acquired data from 4D imagery will be preserved in the form of data set and processed with
appropriate software. Ultrasound examination will assess standards parameters describing
position of the urethrovesical junction, bladder descent, uterus descent, posterior vaginal
wall descent (rectocele, enterocele). Using 3D/4D ultrasound examination the status of the
pelvic floor will be evaluated (presence of avulsion of puborectalis muscle, abnormal genital
hiatus distension). Women will be randomized into three groups: 1. Group - Laparoscopic
sacrocolpopexy 2. Group - Transvaginal mesh procedure 3. Group - Amreich-Richter procedure
(traditional vaginal wall repair with apical fixation to sacrospinous ligament.
All surgical procedures will be performed under general, spinal or epidural anesthesia where
indicated, and antibiotic prophylaxis will be used. Surgery will be provided in standardized
steps, see arm descriptions.
In an early postoperative check-up 2-3 weeks after surgery evaluation of post-operative pain
will be performed and late post-operative complication such as de novo constipation, urinary
retention, infections analyzed. The next post-operative complete examination is planned for 3
months after surgery (the same examination as before the procedure including clinical exam,
ultrasound the QoL (ICIQ- SF, POP-SF, PISQ 12, UDI_POPDI-CRADI, TS-VAS). The next visits will
be provided one year and two years after surgery, and the procedure will be the same as at
the 3-month check-up. In addition to pre-operative ultrasound examination the position of the
mesh will be monitored. All patients in this study will have a minimum one year follow-up
and, whenever possible, a two year follow-up. Postoperative follow-up will be terminated if
the result of surgery is evaluated as a failure, and in these cases reoperation will be
offered. Further post-operative follow-up up to five years is also planned.
