SUperiority of Perineoplasty as concomitant surgical procedure during Pelvic Organ prolapse Repair: a comparative cohort Trial (SUPPORT)

Yearly about 17,000 operations are performed in the Netherlands to repair
pelvic organ prolapse (POP), The aim of prolapse surgery is to restore pelvic
floor function by correcting the anatomical abnormalities involved in POP as
optimally as possible. One of the main problems with pelvic organ surgery is
the high rate of recurrent prolapse. One out of every nine women is operated
for POP but one out of four surgical procedures is performed in a patient that
has been operated before for POP.
In order to restore pelvic floor function, the support of the vagina needs to
be reinforced. The vagina is according to deLancey supported at three levels.
Level I the upper suspensory ligaments (apical support of the vagina)
Level II pubocervical and rectovaginal fasciae (lateral support of the vagina)
Level III pelvic floor muscles of the levator ani. (support of the vagina to
the perineal body)
Loss of level I support leads to prolapse of the uterus or vaginal vault (in
case of previous hysterectomy), level II defects lead to recto-, entero- and
cystoceles and insufficient level III support leads to a wide vaginal hiatus,
which predisposes for (recurrent) pelvic organ prolapse. Worldwide clinical
practice has always focused on level I and level II repair, about which there
is a large amount of research and solid evidence about which intervention
should be performed for which indication. However, there is a paucity of
evidence on the added value of surgery to address level III support, which
results in significant practice variation. The decision whether or not to
perform level III repair depends fully on the individual preference of the
surgeon. In addition, perineoplasty has among many gynecologists a bad
reputation as in the past the surgical technique involved the puborectal
muscles which is associated with a significant risk of de novo dyspareunia. The
surgical technique that is proposed in this project involves the
bulbocavernosus muscles, which is unlikely to result in dyspareunia. It is
known that a wide genital hiatus is related to both a higher risk of level II
defect and a higher risk of recurrent prolapse after prolapse surgery. As a
result we hypothesize that perineoplasty reduces the size of the genital hiatus
and so, reduces the risk of recurrent prolapse. This is suggested by some
retrospective studies, and supported by clinical observation. However, well
designed prospective studies have never been performed, explaining the lack of
agreement about the exact added value of perineoplasty and significant practice
variation.

This study aims to demonstrate superiority of the research intervention (over
standard of care) in [1] surgical success and [2] cost-effectiveness and
non-inferiority in morbidity

Prospective comparative cohort study.

The burden is minimal (filling in the questionnaire four times and visiting two
extra outpatient clinics). This is also estimated as such by the patient
organisation.
The risk is negligible because it concerns evaluation of usual care.