A randomized controlled trial of physiotherapy in patients with fecal incontinence

Fecal incontinence (FI) is a major health care problem, which is highly
embarrassing and affects about 2 to 24% of the adult population. FI can be
defined as the recurrent involuntary excretion of feces in inappropriate places
or at inappropriate times. FI is dependent on sensory, motoric and reservoir
functions. Often, a multifactorial cause is present.
Initially, treatment consists of dietary adaptations and pharmaceutical
interventions. In case of failure, physiotherapeutic treatment of FI is often
considered a first-line approach due to its safe and non-invasive nature.
However, the effectiveness of physiotherapy in FI is unclear.

This study is carried out to assess the effectiveness of rectal balloon
training (RBT)combined with pelvic floor muscle training (PFMT) compared to
pelvic floor muscle training alone in a population of patients with FI.

One hundred patients are randomized to receive either PFMT combined with RBT or
PFMT alone. Baseline measurements consist of the standard work-up, the Vaizey
incontinence score, Fecal Incontinence Quality of Life scale (FIQL) and the
PREFAB-score. Follow-up measurements are at three, six and 12 months.
Physiotherapeutic treatment is performed in the office by skilled motivated
pelvic physiotherapists, who are registered at the Dutch Society for Physical
Therapy in Pelvic Floor Disorders and Pre- and Postnatal Healthcare (NVFB).
Twelve physiotherapeutic treatments are administered during three months
according to a standardized protocol. Success of physiotherapy is defined as a
reduction in Vaizey score of >= four points compared to baseline measurement.

Physiotherapeutic treatment is administered according to a standardized
protocol, which has been developed by clinicians and physiotherapists
specialized in the field of pelvic floor disorders. Physiotherapeutic treatment
consists of pelvic floor muscle training and rectal balloon training (only
trial arm 1). Patients receive 12 physiotherapeutic treatments within three
months.

In total, the patient visits the hospital 5 times during approximately 14
months. The first three visits are part of the normal routine assessments at
the clinic. Visit 4 and 5 are planned to follow the progress of the patient in
time. Visit 1, 3, 4 and 5 are 30 minutes in duration, whereas visit 2 is four
hours in duration. The diary is filled in at home (5 minutes a day during three
weeks) and the questionnaires in between the diagnostic tests (15 minutes per
visit).
The content of the physiotherapy program differs between both groups, although
overall treatment time is equal. It is possible that the results in both groups
are comparable concerning the functional recovery. In this case, a lower burden
is present in the group that only receives PFMT.
It is hypothesized that the combined use of RBT and PFMT is more effective than
PFMT alone. This means that patients in this group might have a quicker
functional recovery after physiotherapeutic treatment.
Both RBT as well as PFMT have less reported side effects and therefore are
often tried before surgery. In rare cases, snapping of the rectal balloon might
occur, which is harmless but can give the patient a fright. Treatment is
administered by specialized registered pelvic physiotherapists, who act
according to the guidelines of the Dutch Society for Physical Therapy in Pelvic
Floor Disorders and Pre- and Postnatal Healthcare (NVFB).