Failure Phenotyping: Functional Anatomy-Based Prediction of Pelvic Organ Prolapse Recurrence
Failure Phenotyping: Functional Anatomy-Based Prediction of Pelvic Organ Prolapse Recurrence
批准号:
9910416
负责人:
CAROLYN W SWENSON
金额:
$7.8万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-04-15 至 2021-03-31
关键词:
AddressAnatomyApicalAreaBackBiological MarkersClinicalClinical DataDataData AnalysesDefectFailureFundingFutureGenital systemGoalsGoldHigh PrevalenceHigh Risk WomanKnowledgeLeadLogistic RegressionsMRI ScansMagnetic Resonance ImagingMeasurementMeasuresOperative Surgical ProceduresOutcomePatientsPelvic Floor DisordersPelvic Floor MusclePelvisPhenotypePostoperative PeriodProspective StudiesPtosisRecurrenceRepeat SurgeryResearchResourcesRestRisk FactorsSample SizeScanningSiteStressStructureSupport SystemSurgeonSurgical ManagementSurgical ModelsTechniquesTestingThromboplastinTissuesUnited States National Institutes of HealthVaginaWomanWorkbaseclinical examinationcostevidence basehigh riskindexinglevator ani musclenovelnovel therapeuticsoperationpelvic organ prolapsepredictive modelingrepairedsuccesssurgery outcome
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英文摘要
Abstract
Over 200,000 women undergo surgery for pelvic organ prolapse each year. One of the biggest
current challenges is recurrent prolapse following surgery. At seven years, the failure rate for
the “gold standard” operation performed by expert surgeons in the NIH Pelvic Floor Disorders
Network is 25%. While improvements in surgical management have led to better long-term
outcomes for Level I (apical) support, emerging data indicate that Level III (genital hiatus)
support is not addressed by Level I surgery and may be the most significant predictor of
prolapse recurrence. Current progress is blocked by our lack of understanding regarding the
specific anatomical defects that lead to recurrent prolapse, as well as our inability to identify
women prior to surgery who are at high risk for recurrence.
From a prior NIH-funded study, our research group has preoperative MRIs on 133 women who
underwent surgery for prolapse, and for a subset of these we have limited clinical data about
prolapse recurrence. Preliminary analyses of these data suggest that a novel preoperative MRI
measure of the genital hiatus (∆gh), which is the change in genital hiatus from rest to strain,
may be associated with postoperative recurrence; however, our current sample size is too small
to be able to conduct multivariable logistic regression. We seek funding to bring these women
back for clinical exams to identify anatomical preoperative biomarkers responsible for prolapse
recurrence and, for a subset, acquire postoperative MRI to identify structural failure sites. Pilot
data from this study can then be used to power a larger, definitive study.
AIM 1: Identify preoperative factors associated with recurrence: We hypothesize that the ability
to maintain a closed genital hiatus (gh) will be a predictor of surgical success. Specifically, we
propose a new variable to assess levator status, ∆gh, which is the change in genital hiatus size
from rest to strain. We expect women with a smaller preoperative ∆gh to have a higher
prevalence of recurrence. We will test the hypothesis that preoperative ∆gh is a stronger
predictor of surgical failure than existing measurements associated with levator ani muscles.
AIM 2: Postoperative failure phenotyping: Acquire and compare postoperative Stress MRI for 10
women with recurrence versus 10 women with long-term success following prolapse surgery.
a) We will identify structural failure sites on postoperative MRIs for women with anatomical
recurrence following prolapse surgery.
b) We will test the null hypothesis that there is no difference in Level III support measures
between women with prolapse recurrence and those with long-term success.
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