Abstract
BackgroundPelvic organ prolapse (POP) is a condition affecting more than half of the women above age 40. The estimated lifetime risk of needing surgical management for POP is 11%.In patients undergoing POP surgery of the anterior vaginal wall, the re-operation rate is 30%. The recurrence risk is especially high in women with a levator ani defect. Such defect is present if there is a partially or completely detachment of the levator ani from the inferior ramus of the symphysis. Detecting levator ani defects is relevant for counseling, and probably also for treatment. Levator ani defects can be imaged with MRI and also with Translabial 3D ultrasonography of the pelvic floor.The primary aim of this study is to assess the diagnostic accuracy of translabial 3D ultrasonography for diagnosing levator defects in women with POP with Magnetic Resonance Imaging as the reference standard. Secondary goals of this study include quantification of the inter-observer agreement about levator ani defects and determining the association between levator defects and recurrent POP after anterior repair. In addition, the cost-effectiveness of adding translabial ultrasonography to the diagnostic work-up in patients with POP will be estimated in a decision analytic model.Methods/DesignA multicentre cohort study will be performed in nine Dutch hospitals. 140 consecutive women with a POPQ stage 2 or more anterior vaginal wall prolapse, who are indicated for anterior colporapphy will be included. Patients undergoing additional prolapse procedures will also be included.Prior to surgery, patients will undergo MR imaging and translabial 3D ultrasound examination of the pelvic floor. Patients will be asked to complete validated disease specific quality of life questionnaires before surgery and at six and twelve months after surgery. Pelvic examination will be performed at the same time points.Assuming a sensitivity and specificity of 90% of 3D ultrasound for diagnosing levator defects in a population of 120 women with POP, with a prior probability of levator ani defects of 40%, we will be able to estimate predictive values with good accuracy (i.e. confidence limits of at most 10% below or above the point estimates of positive and negative predictive values).Anticipating 3% unclassifiable diagnostic images because of technical reasons, and a further safety margin of 10% we plan to recruit 140 patients.Trial registrationNederlands trial register NTR2220.
Highlights
Pelvic organ prolapse (POP) is a condition affecting more than half of the women above age 40
In a previous study we showed anatomical recurrence of cystocele was associated with major levator defects with an odds ratio of 2.5 (95% confidence interval (CI) 1.1-5.7, p = 0.03) [18]
Recent advancements in imaging allow assessment of the levator ani muscle imaging with 3D pelvic floor ultrasound, comparing it to MR imaging as the reference standard
Summary
Pelvic organ prolapse (POP) is a condition affecting more than half of the women above age 40 [1]. Recent advancements in imaging allow assessment of the levator ani muscle imaging with 3D pelvic floor ultrasound, comparing it to MR imaging as the reference standard. Steensma and co-workers have conducted a test-retest series of 50 volume datasets of patients with pelvic floor dysfunction for diagnosing levator defects to assess inter-observer reliability, which yielded a Cohen’s kappa of 0.83 (95% Confidence interval (CI) 0.59,1.0), meaning excellent agreement [11]. The main objective of our study is to estimate the diagnostic accuracy of translabial 3D ultrasonography of the pelvic floor as compared to MR imaging, the reference standard, for diagnosing levator defects in women with POP. The second aim of this study is to estimate the level of agreement between observers and determine whether levator defects are a risk factor for recurrence after POP surgery. The cost-effectiveness of introducing translabial ultrasonography in the work-up of a patient with POP will be estimated in a decision analytic model
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