Pelvic floor exercises compared to medication in the treatment of older men with lower urinary tract symptoms (LUTS) in general practice. The FLOW study.

The standard treatment in general practice for men with Lower Urinary Tract
Symptoms, (LUTS) is with drugs from the class of alpha1-receptor blocking
agents. Pelvic floor muscle training may be an alternative for drug treatment
of LUTS: it is harmless and has no side effects. The effects of pelvic floor
muscle training have not yet been studied in a randomized clinical trial,
comparing this treatment with the standard treatment. The hypothesis is that
pelvic floor muscle training has a favorable effect on the symptoms and
improves the quality of life of men with LUTS in general practice more than the
standard treatment with medication.

The primary objective of the study is to study the effects of pelvic floor
physiotherapy compared to treatment with α1-blocking agents in men with lower
urinary tract symptoms.
The secondary objective is to study the effects of the two therapies on quality
of life, the maximal and mean flow of urine, sexual functioning and to study
the patient*s global impression of improvement.
A pilot is necessary to study the feasibility of the recruitment procedure, the
protocol for the pelvic floor physiotherapy and the measures of spread of the
outcome parameters in a general practice population.

The design of the study is an open label, randomized controlled trial. Patients
will be randomized 1:1 to a group receiving pelvic floor exercises or to a
group receiving medication. The follow up period is 3 months.

The patient group randomized to pelvic floor physiotherapy will be referred to
a registered pelvic floor physiotherapist. In 6-9 sessions the patient will be
educated on the role and function of the pelvic floor muscles in LUTS and on
how to use this muscles to improve the micturition. The patient group
randomized to the standard treatment with medication will be prescribed α1-
receptor blocking agents (tamsulosin or alfuzosin) by his general practitioner.
Duration of the two interventions is three months

The risks of the study are minimal, as all investigations are non-invasive. The
treatment in the medication group is non-experimental and the treatment in the
pelvic floor exercise group has no side-effects.
The burden of the study for the participants consists of filling in
questionnaires, keeping a day bladder diary, undergoing a digital rectal
examination and a measurement of the electrical activity of the pelvic floor
muscles, urinating in a uroflowmeter and having a ultrasound examination of the
lower abdomen to assess the post-void residual volume.
The results of the study may contribute to our knowledge about alleviating
symptoms of the lower urinary tract in men. Pelvic floor physiotherapy may turn
to be an alternative for drug treatment