The Influence of Pelvic floor muscle function on pessary Treatment success in patients with pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a common problem in middle aged women. In the
Netherlands, the prevalence of symptomatic POP in women between 45-85 years is
11.4%. A pessary is a relatively inexpensive treatment option that reduces POP
symptoms. However, the success rates of pessary fitting range between 58 and
73% for the regular ring pessary. Furthermore, researchers and clinicians have
different thoughts about the position of a pessary inside the body and research
into risk factors associated with unsuccessful pessary fitting shows
conflicting results. Imaging techniques can be used to evaluate the position of
a pessary. A recent study within our group using upright magnetic resonance
imaging (MRI) suggests that the pessary is supported by the pelvic floor
muscles.
Considering these findings, the function of the pelvic floor muscles appears to
be of essence to the success of pessary treatment. Myofeedback measurements
have been used to investigate the function of the pelvic floor muscles,
especially in pelvic floor physiotherapy. Moreover, 4 dimensional (4D)
transperineal ultrasound (TPUS) derived strain assessment has emerged as a
non-invasive tool to investigate both the pelvic floor function and anatomy.

There is a large amount of unknowns considering the support of a pessary.
Insight in these unknowns may be useful to optimize the pessary treatment and
reduce the complication rate and the amount of unsuccessful fittings.

The ultimate objective is to optimize pessary treatment for all patients with
pelvic organ prolapse (POP). To reach this goal, we need to learn more about
the mechanisms behind success and failure of pessary treatment. Previous
research suggested that the pelvic floor has a supporting role for the pessary.
From this follows the hypothesis that pelvic floor muscle function influences
the success chances for pessary treatment in patients with POP. More
specifically, that a better pelvic floor muscle function is associated with a
higher chance of pessary treatment success. With the current study the first
step towards testing this hypothesis is set. Hence, the main objective of this
study is to identify differences in pelvic floor muscle function between
patients with POP that have a successful pessary treatment, patients with POP
that have an unsuccessful pessary treatment, and healthy controls.
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The secondary objectives are:
• to evaluate the different tools for pelvic floor muscle function
quantification (myofeedback and TPUS) for the assessment of pelvic floor
function in POP patients
• to evaluate the relation pelvic floor muscle function to clinical POP symptoms
• to identify pelvic (floor) anatomy characteristics that play a role in the
success and failure of pessary treatment in POP patient.

This prospective, observational study will collect pelvic floor function and
anatomy measurements of 40 POP patients and 20 healthy volunteers without
symptomatic POP. The participants will undergo pelvic floor muscle function
measurements in a single visit to the outpatient clinic of ZGT (location
Hengelo) by myofeedback (MAPLe and TMSI) and TPUS. The TPUS measurements also
provide ultrasonographic information about the pelvic anatomy. In addition to
these measurements, questionnaires will be obtained during this visit as well:
a general questionnaire (similar to previous trials EPPA NL74061.091.20 and
FYSIO NL85627.100.23) and the validated PFIQ-7 and PDFI-20 questionnaires.

There is a limited burden for patients to participate in this study. The first
burden is travelling, all participants need to go to the ZGT-hospital (Hengelo)
for the questionnaires, and the TPUS and myofeedback measurements. However,
were possible the study measurements will be combined with the regular
outpatient clinic visits of the patients. The second and final burden of this
research is based on filling in questionnaires on general health and pelvic
floor symptoms.