TRanslabial 3D-Ultrasonography for DIagnosing Levator defects

Completed

Conditions: verzakking van blaas in vagina
pelvic floor dysfunction
pelvic organ prolaps
10018188

Registration Number: NL-OMON35109

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

140 women with at least POPQ stage II prolapse of the anterior compartment who are scheduled for colporaphia anterior with or without other pelvic organ prolapse procedures.

Exclusion Criteria

Exclusion criteria are previous prolapse surgery, the intention to use mesh-materials or contra-indications for MR-imaging such as a pace-maker, artificial valves, protheses, claustrofobia.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome:<br /><br>1. The diagnostic test performance of translabial 3D ultrasound as compared to<br /><br>MR imaging in detecting<br /><br>levator defects will be determined. Accuracy will be expressed in terms of<br /><br>sensitivity, specificity, and<br /><br>predictive values, and their 95%-confidence intervals. For the calculation of<br /><br>95%-confidence interval the<br /><br>Wilson formula for proportions will be used.<br /><br>ROC analysis will be performed for the grading of the size of levator defects<br /><br>with 3D ultrasound</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures:<br /><br><br /><br>2. Inter-observer agreement in diagnosing levator defects with 3D<br /><br>ultrasonography.<br /><br>3. relation between existence of levatordefects and complaints.<br /><br>4. Determination whether levator defects are an independent risk factor for<br /><br>recurrence after POP<br /><br>surgery.<br /><br>5. Potential cost-effectiveness of introducing 3D ultrasonography for<br /><br>diagnosing levator defects in the<br /><br>work-up of a patient with POP.</p><br>