Exploring pelvic floor signs and symptoms in community dwelling women and men: a mixed-method study

Pelvic floor symptoms (PFS) are prevalent and often impair quality of life.
They include micturition problems, defecation problems, pelvic organ prolapse,
sexual problems and genito-pelvic pain. The pelvic floor is an anatomical and
functional unit, and therefore different PFS may co-occur. However, literature
on prevalence of clusters of PFS is scarce. Furthermore, PFS is understudied in
the male population and when studies are performed in male subjects, studies do
not assess the complete scope of possible PFS. Currently, different secondary
care specialists treat PFS. This may lead to successive diagnostic tests,
sub-optimal treatments, high patient burden, and substantial medical costs.
Primary care would be an ideal setting for an integrated approach early in the
course of symptom development in order to prevent complexity and chronicity of
PFS.

The primary aim of the study is to generate a cohort, which provides
information on sex- and gender differences in: prevalence and incidence of
(clinically relevant clusters of) PFS, risk factors and prognostic factors for
PFS, factors that reveal the impact of PFS on daily life, help seeking behavior
and use of health care.

A prospective observational population-based cohort study will be conducted
with follow-up moments after 1 year and 2 years. Data of the questionnaire will
be connected to medical record data from the participating general
practitioners (GPs). A representative sample of female and male subjects with
and without PFS will be invited for a physical examination to assess pelvic
floor disorders and muscle function. Furthermore, a subsample of patients will
be invited for a qualitative study consisting of semi-structured interviews on
help seeking behavior, including barriers and facilitators, preferences and
satisfaction.

Participants have to fill in a questionnaire consisting of eleven parts for
female subjects and ten parts for male subjects. The total time to complete the
questionnaire will be around 45-60 minutes. As some questions will be on
personal, intimate and sexual items, participants might feel uncomfortable
filling in those questions. Otherwise, burden of filling in the questionnaire
is negligible. Subjects, who provided specific informed consent for sub-study,
will undergo additional research consisting of approximately 20 minutes in case
of physical examination and 60 minutes in case of an interview.