TORBO: Research in Twente on Recurrences after Pelvic Organ Prolapse Surgery

Rationale: Pelvic organ prolapse (POP) is characterized by a pelvic floor organ
(e.g. bladder, uterus, bowel) protruding (prolapsing) from the opening of the
vagina. The main treatment options for POP are conservative treatment with a
pessary or surgical correction. In the Netherlands, the prevalence of
symptomatic POP in women between 45-85 years is 11.4% and the average number of
women who receive surgery based on complaints of POP or urinary/fecal
incontinence are as high as 10-20%. Multiple (combinations of) POP are defined,
based on the prolapsed organ: anterior, apical and posterior compartment
prolapse. Based on the physical complaints, recurrence surgery and the
prolapsed compartment(s) the best surgical treatment option is selected. The
different options are: anterior/posterior colporrhaphy, sacrospinal fixation
(SSF), (modified) Manchester Fothergill (MF), rectopexy, sacrocolpopexy (SCP)
and vaginal hysterectomy (VH). Surgical correction has turned out to be highly
effective, however the estimated risk of reoperation over a period of 4 years
is 30%, while reasons for recurrences are poorly understood. At the University
of Twente (UT) we have the unique possibility of visualizing the pelvic floor,
and pelvic organ prolapse in upright position.
Hypothesis: Recurrences and continuation of physical complaints might be
related to the pre-operative and post-operative (incomplete) assessment of the
prolapse (POP-Q) in supine position. Crucial anatomical details, related to
surgical treatment and success are missed or underdiagnosed.

Objective: This protocol describes a framework that will be used to create
different studies. The general primary and secondary objectives of this
protocol are stated below:
Primary objective:
Investigate the effect of surgery on the position and shape of the pelvic
organs, the functionality of the pelvic floor muscles and it relation to
recurrences and differences in the assessment of prolapse recurrences in supine
and upright position.
Secondary objectives:
• Evaluate to what extend pelvic organ prolapse is lifted at 6 weeks after
surgery in supine and upright position
• Evaluate the correlation between improvement in physical
discomfort/complaints after surgery (based on questionnaires) and the changes
in anatomy (based on imaging).
• Evaluate the percentage of recurrences after surgery in upright position
(based on imaging) as compared to currently known percentages in supine
straining position (based on physical examination)
• How do recurrences develop over time?
• What are the main difference before surgery and after surgery between
patients with and without recurrences?
• What is the relation between MRI based anatomical parameters, ultrasound
based pelvic floor muscle function, physical examination (POP-Q as is regularly
done in clinical practice) and patient*s experiences (questionnaires)?

This document is a framework from which different studies will be established
in different phases (as was done for the EPPA-study ref number:
NL74061.091.20). Each study is designed as a prospective (multiple) cohort
longitudinal study

In the first study (Appendix 1 - Blaasverzakking) we ask patients with surgery
for at least a prolapse of the anterior compartment (e.g. bladder) to visit the
ZGT hospital and University of Twente for a total of four times (pre-operative;
6 weeks post-operative; 1 year post-operative; 2 years post-operative).
In the second study (Appendix 2-Rectopexy) we ask patients planned for
rectopexy surgery to visit the ZGT hospital and University of Twente for a
total of three times (pre-operative; 6 weeks and 1 year post-operative).
ZGT visits: During these visits of approximately 30 minutes, patients will
undergo physical examination (POP-Q measurement), fill in four questionnaires
(PGI-I, UDI, PISQ and ODS, with a total of 20 questions) and have a
transperineal ultrasound examination. POP-Q measurements are standard clinical
practice, questionnaires are validated with limited amount of questions and the
ultrasound is non-invasive (positioned against the labia).
UT visits: During these visits of approximately 30-60 minutes, patients will
undergo a supine and upright MR scan (no ionizing radiation) in the 0.25T
scanner. During the MR scanning procedure the patient needs to lie or stand
still. In upright position, some people may experience some dizziness because
of this. To prevent this, the patient is encouraged to move her toes between
the different scans. If dizziness is noticed, the scan will be aborted
immediately and the participant is turned back to the horizontal position. The
risks associated with MRI are negligible (only very limited amount of dizziness
reported in previous pelvic floor related scanning).