Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03534830 |
| Other study ID # |
00031263 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2018 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University of South Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The research objective of this proposal is to investigate the clinical utility and validity
of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ
prolapse following advanced surgical procedures. Estimated levator ani subtended volume
(eLASV) is a reproducible magnetic resonance image of the female pelvis that objectively
quantifies the integrity of the pelvic floor levator ani muscles. A woman's levator ani
muscle anatomical shape is unique to her as a result of her own individual lifetime risk for
development of pelvic floor dysfunction. The novelty of eLASV as a measurement of muscle
integrity, separates it methodology from the solitary of diagnosing partial trauma or defects
as previously published within the literature. eLASV measurements have the potential to
identify women at increased risk for surgical failure and may be used as a prognostic tool to
aid in future counseling and stratification of patients into surgical options for treatment
of pelvic organ prolapse.
Description:
Pelvic floor disorders affect millions of women within the United States daily, with nearly
25% of all women currently have some form of pelvic floor dysfunction [1]. An estimated
200,000 women undergo surgery annually for pelvic organ prolapse [4-6], and recent
projections estimate that the number will increase to approximately 250,000 by year 2050 [7].
Up to 30% of these women, will undergo a second surgical procedure for recurrence of prolapse
following their first surgery [2]. Astoundingly, resulting in 60,000 - 75,000 women a year
undergoing a second advanced gynecological surgical procedure for pelvic organ prolapse
consequently increasing the patients' perioperative risk and the overall cost of women's
healthcare nationwide.
Levator ani muscle plays an important role in pelvic support. Weakening or direct trauma to
the muscle is currently the best-defined pathogenesis for development of pelvic organ
prolapse and for the recurrence of prolapse after surgical repair [7-13]. Levator ani
avulsion has been demonstrated to be a clinical predictor of cystocele recurrence following
anterior colporrhaphy with native tissue and with mesh augmentation [11,12]. However, further
studies are warranted to investigate of levator ani muscle integrity as a predictor for
surgical outcomes after more advance surgical procedures.
The investigators demonstrated an objective measure of levator ani muscle integrity (eLASV)
calculated from standard 2D dynamic pelvic MRI measurements (H-line and M-line) obtained
directly from radiology reports along with one 2D linear measurement that is easily obtained
from radiographic images [13-15]. The novelty of eLASV as a measurement of the entire muscle
integrity, separates it methodology from the solitary of diagnosing partial trauma or defects
as previously published within the literature. eLASV is a novel objective measurement of
levator ani muscle integrity and measures all three portions of the muscle (puborectalis,
pubococcygeus, and iliococcygeus) as a whole complex. Transvaginal and transperineal
ultrasonography along with CT scans or xRays of the pelvic floor are unable to image at the
high level resolution imperative for complete reconstruction of the entire levator ani
muscle.
Each woman's levator ani muscle anatomical shape is unique to her as a result of her own
individual lifetime risk for developement of pelvic floor dysfunction. Consider the levator
ani muscle as a kitchen bowl varying in different shapes and sizes for each individual woman.
Now consider filling these varying shapes and sizes of the kitchen bowls with water, eLASV is
the objective three dimensional measurement of the volume of water contained within each
different muscle complex.
When the volume of eLASV is elevated, it represents a measurable change in the anatomical
shape of the muscle as a result of loss of the muscle integrity for support of the pelvic
floor. As Decreased support of the levator ani muscle within the pelvic floor will result in
an increased strain on the supportive ligament structures within the female pelvis [16,17].
Increased strain on the supportive structures including the uterosacral ligament,
sacrospinous ligament, paravaginal support, etc., could result in an increased risk of
recurrence for prolapse following advance pelvic reconstructive surgery.
eLASV may have the potential to identify women at increased risk for surgical failure and
could be used as a prognostic tool to aid in future counseling of patients on surgical
options for treatment of pelvic organ prolapse. Identification of women at an increased risk
for surgical failure following advanced surgical procedures would be invaluable in a surgical
subspecialty that has a reoperation rate as high as 30% after a primary surgery [2].
Personalized medicine and patient selection thus far has played a very small role in the
discussion regarding the use of mesh versus native tissue repair in female pelvic
reconstructive surgery. Patient stratification into certain reconstructive procedures will
likely change once clinicians become better at diagnosing levator ani trauma and identify
patients at high risk of prolapse recurrence after reconstructive surgery [8]. Abdominally
placed mesh, either via robotically, laparoscopically, or open, for a sacral colpopexy is
considered the gold standard for apical suspension in patients with pelvic organ prolapse
[18]. However, there is an increased concern for the use of synthetic mesh in reconstructive
pelvic surgery [19].
This study represents a step in the direction of identifying patients at increased risk for
surgical failure and the potential of stratifying future patients into specific surgical
procedures based on their own individual likelihood of success vs failure after an advanced
pelvic reconstructive procedure improving patient outcomes.
Approach: The specific aims of this project will be fulfilled through a combined qualitative
and quantitative approach. The investigators plan to test the feasibility of executing a
prospective cohort trial investigating the clinical utility of eLASV as a preoperative
biomarker and prognostic tool to predict surgical outcomes in pelvic organ prolapse by
assessing the study design/process, resources available, management and time barriers, along
with the scientific merit of the study. The investigators will also plan to test the validity
of eLASV calculation and pilot test eLASV as a biomarker at 38.5 to predict surgical outcomes
for laparoscopic uterosacral ligament suspension. The investigators will then use the
information gathered from our pilot study to refine or modify the research methodology to
develop a larger, NIH grant supported prospective cohort control trial.
