Evaluation of pelvic organ prolapse using upright magnetic resonance imaging

Pelvic organ prolapse (POP) is a common condition in middle aged and elderly
women. Approximately 10% of women will have surgery for POP and/or urinary
incontinence during their lifetime. Surgical correction of the POP is effective
but unfortunately in 30% of the cases a residual prolapse occurs. It is unclear
why these recurrences occur. One of the theories is that with our traditional
physical (gynecological) examination anatomical details of the POP, that are
crucial for surgical repair and success, are missed. In the last decades
imaging techniques, like ultrasound and MRI, have been developed to study the
anatomy of the pelvis in healthy but also POP patients. MRI offers a superior
detail of the organs and muscles under study, but unfortunately imaging of the
pelvic floor is performed only in supine position. The effect of gravity, which
is crucial to develop POP symptoms, is not taken into account in this supine
position. Recently, a low-field MRI system was introduced which offers the
possibility to scan the patient in a weight bearing, upright position. If the
images obtained with this standing MRI are associated with POP severity and
show us the anatomical defects in more detail, this information may be useful
to fine tune surgical techniques and reduce recurrences.

An explorative study, that will include 15 patients and 15 volunteers without
pelvic floor disorders, will be conducted to evaluate the possibilities of an
open 0.25T MRI- system to assess the pelvic floor and to get a better
understanding of the manifestation of POP in a natural occurring position. This
explorative study would enlighten changes in the pelvic floor anatomy and
landmarks in supine and standing position. This is observed in the static (in
rest) and dynamic (during contraction in the pelvic floor) situation, during a
pre- and post-operative scan. The parameters used to interpret the supine
imaging are evaluated on usefulness in upright imaging as well as how they
change with the positioning. This pilot study will assess the feasibility for a
larger study, with the aim to find parameters which are associated with the
outcome of prolapse surgery. MRI could give additional information as
preoperative diagnostic tool to predict outcome of surgery, e.g. identify those
prone to develop recurrence. According to these prognostic parameters obtained
with this study, surgical interventions could be adjusted to improve the
outcome and reduce the recurrence.

Prospective cohort study, where the images of 15 patients will be obtained 1-4
weeks before and 6 weeks after surgery. The patients on the waiting list for
the prolaps surgery (at MST/ZGT), which meet the inclusion criteria, will be
called by the gynaecologist , to ask if the investigator can send them the
written information about the study and approach them afterwards. If she is
willing to participate, the next consult at the gynecologist after the
diagnosis but for the operation, she will sign the informed consent, before the
POP-Q in standing and lying position is performed. On the same day (or
another), the patient will be asked to be scanned in an open 0.25 T MRI
[CE0051] at the University of Twente. During this scan, the participants are
positioned in both supine and upright position, where a scan in static and
dynamic (contraction and squeezing) situation will be obtained. The duration of
the exam itself will be 1 hour.

Also, 15 volunteers without pelvic floor disorders will be recruited by hanging
leaflets around the University of Twente asking for volunteers. When people are
interested they will have a brief contact with the coordinating investigator
who will check whether they meet all requirements. If everything is in order
more information regarding the study will be sent to the volunteers and they
are invited to the University of Twente for the scans. The volunteer will be
scanned with the 0.25T rotatable MRI [CE0051]. The volunteers will be scanned
in upright and supine position, in both a static and dynamic (during
contraction and squeezing) situation. A possible outcome is that the total
number of 15 volunteers will be not reached when a significant difference
between patients and volunteers is already apparent at a smaller amount.

The burden associated with participation is that volunteers without pelvic
floor disorders need to visit the university once for a scan. Patients need to
visit the university twice: before and after surgery.

Each appointment will roughly take one hour. To perform the upright scan, the
participant needs to stand still for at most 15 minutes. During this position,
some people experience dizziness, if this happens the scan can be aborted
immediately and the patient is turned back to the horizontal position. Still
the risks associated with this MRI examination are negligible. The participant
need to empty their bladder 1/2 hour prior to the visit and is preferred not to
void after the measurements are completed.