TRanslabial 3D-Ultrasonography for DIagnosing Levator defects

TRanslabial 3D-Ultrasonography for DIagnosing Levator defects - TRUDIL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35109

Enrollment

140

Registered

2010-02-22

Start date

2010-06-01

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verzakking van blaas in vagina pelvic floor dysfunction pelvic organ prolaps

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results