TRanslabial 3D-Ultrasonography for DIagnosing Levator defects

In the Netherlands 13.000 patients undergo surgical correction for pelvic organ
prolapse (POP) yearly.
These operations are known to have a high re-operation rate of 30% because of
primary failure and
secondary recurrence of signs and symptoms of POP.
Translabial 3D ultrasonography of the pelvic floor is a new method which can be
used to judge the
integrity of the levator ani muscle. Levator defects can occur during
childbirth and are associated with
POP and possibly with recurrence after POP surgery. If the diagnostic test
characteristics of this
technological innovation are satisfactory for diagnosing levator defects and
the relation with recurrence
is confirmed, it will be possible to identify a subgroup of patients at risk
for recurrence after conventional
POP surgery. Identification of women at risk for recurrence of POP can result
in a better selection of the
type of surgery.

Objective:
Primary aim of the study is estimating 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. Our secondary aim is estimating the level of agreement between
observers. We will
examine whether levator defects are a risk factor for recurrence after POP
surgery. In addition the
cost-effectiveness of introducing translabial ultrasonography in the work-up of
a patient with POP will be
estimated in a decision analytic model.

Design:
Multicentre prospective observational cohort study.

Study description:
The patient*s local gynaecologist fills out a case record form. From each
patient baseline characteristics
will be recorded. Patients will be invited by the study nurse for an
appointment. This visit is the baseline
measurement and will include the following interventions:
1. Questionnaires;
2. Physical examination;
3. Translabial 3D ultrasonography;
4. MR Imaging.
Case record forms on the precise technique of operation and complications will
be completed. A follow
up appointment is made 6 weeks and 6 months postoperatively. At these
measurement moments a
physical examination for staging of POP will be performed to diagnose an
anatomical recurrence and
questionnaires regarding quality of life and subjective feelings of recurrence.

Burden for patient associated with participation:
MR imaging and 3D ultrasound of the pelvic floor have to be performed
preoperatively to image the pelvic floor and possible damage to the pelvic
floor, such as levatordefects. Futhermore patients do fill in a questionnaire 4
times. Patients are invited twice for follow-up after 6 and 12 months.

Risks for patient associated with participation:
There are no known risks associated with participation. MR imaging and
ulstrasound scanning are harmless examinations without the use of radiation. If
a patients asks for she can be informed at the end of the study about the
conclusion of her MRI and ultrasound concerning a levatordefect. The existence
of a levatordefect ca possible explain the occurence of prolaps partly, but it
cannot be solved.