Pelvic organ prolapse in general practice: effects of pelvic floor physiotherapy and of pessary treatment

A pelvic organ prolapse (genital prolapse) is a condition of which the
prevalence increases significantly after the menopause. Different stages of
severity can be distinguished and it may cause a range of symptoms which are
partly specific and partly atypical. The prevalence of pelvic organ prolapse is
10-15 % in older women and it is a not life- threatening but potentially very
invalidating condition. It has a negative influence on the quality of life of
affected women because it causes physical and psychological problems and
interferes with sexuality. Only a minority of women ask for help for their
symptoms.
Because pelvic organ prolapse is a disorder of older women, there is a need for
research concerning conservative, non-surgical treatments. Operative procedures
for prolapse may be contra-indicated in older women beacuse of co-morbidity or
vulnerability. However, the effects of conservative treatments like pessaries
and pelvic floor exercises have not been studied adequately. This project aims
at filling the gap in our knowledge by comparing conservative treatments of
genital prolapse. This is very relevant for general practitioners as they treat
75 % of the women with a pelvic organ prolapse. It is also very relevent for
the growing category of older patients for whom an operation is not an option.
Given the lack of evidence on the effects of conservative treatments for
genital prolapse, the general practitioner currently has to guess which
treatment should be advised.

The objective of the project is to study the effect of conservative,
non-surgical treatments of pelvic organ prolapse in a randomized clinical
trial. The treatments under study, pessaries and pelvic floor physiotherapy,
aim at reducing the symptoms of a genital prolapse, at improving the function
of the plevic floor muscles, at preventing the prolapse from getting worse and
at reducing the need for operative procedures. The study focusses on the age
category with the highest prevalence and incidence of prolapse symptoms, that
is postmenopausal women. Because many women with prolapse symptoms hesitate to
seek help for their problems, all women of 55 and older will be actively
approached.
The following questions will be studied:
1.What are the effects and what are the costs of treating older women with a
mild prolapse with pelvic floor exercises compared to a expectant policy
2.What are the effects and what are the costs of treating older women with a
moderate prolapse with pelvic floor exercises compared to pessary treatment.

The design of the study is an open label randomized clinical trial which aims
at studying the effects of conservative treatments of a pelvic organ prolapse
in older women. The trial consists of two parts: in the first part the effect
of pelvic floor physiotherapy will be compared to wait and see in women with a
mild prolapse. In the second part, pessary treatment will be compared to pelvic
floor physiotherapy in women with a moderate prolapse.
Follow up measurements will take place 3 months after the inclusion in the
trial or the start of the treatment, respectively and after 1 and 2 years.

Women, who have a pelvic organ prolapse according to the urogynaecological
examination, will be included in one of two intervention studies, depending on
the degree of prolapse:
1. A study in women with a mild prolapse: the deepest point of the prolapse
remains above the hymenal ring during maximal Valsalva. (stage 1 and mild stage
2 in the POP-Q ordinal scale). In this category of women the effects of pelvic
floor exercises will be compared with a wait and see strategy. Participants in
this part of the study will be randomized to treatment by a pelvic floor
physiotherapist or to no active treatment, after informed consent
2. A study in women with a moderate prolapse: the deepest point of the prolapse
passes the hymenal ring during maximal Valsalva. (advanced stage 2 and stage 3
in the POP-Q ordinal scale). In this category of women the effects of pelvic
floor exercises will be compared pesary treatment. Participants in this part of
the study will be randomized to treatment by a pelvic floor physiotherapist or
to treatment with a pessary, after informed consent.

All diagnostic and therapeutic procedures applied in this study, are standard
procedures in evaluating and treating pelvic organ prolapse. All examinations
are non-invasive and will cause no harm to the patient. The pelvic floor
exercises have no adverse effects. Treatment with a pessary may cause
irritation of the vaginal wall or vaginal discharge in case of an imperfect
fit. The patients in the pessary group will be instructed to contact the
resaerch physician or their own GP in case of symptoms related to the pessary.
Besides, they will be monitored every three months to detect symptoms in an
early stage (as is standard care in the Netherlands in women who wear
pessaries).
The burden of the study for the patients consists of filling in questionnaires,
of a urogynaecological examination and, depending on the treatment for which
they are randomised, of visiting a plevic floor physiotherapst or the fitiing
and wearing of a pessary. These treatments belong to the usual care options in
general practice in case of a pelvic organ prolapse.