Pelvic floor therapy in the treatment of all anal fissures; a multicentre, randomized controlled trial

Anal fissures are ulcers in the anoderm, that mostly are the result of the
passage of hard stool. Because of the hypertonia of the pelvic floor muscles
and high pressure of the internal sphincter, the blood flow is compromised,
resulting in a delay of healing and an increase in pain.
Therapy is based on relaxing the internal sphincter and this can be achieved in
different ways. Current non-surgical therapy have smaller success rates
compared to lateral internal sphincterotomy (LIS) in terms of healing and
recurrence. However, LIS, is only an option to be considered after failure of
medical therapy because of the risk of permanent fecal incontinence. Since
current treatment options are unsatisfactorily in healing a fissure, it*s our
opinion that other possible therapies without risk of incontinence should be
pursued.
We believe that an anal fissure can be successfully treated with pelvic floor
therapy. Pelvic floor therapy relaxes the pelvic floor musculature and
decreases the internal sphincter tension, thereby restoring blood flow to the
anal fissure. It is therefore our hypothesis that pelvic floor therapy
increases the success rates in the treatment of anal fissures, in terms of
earlier pain relief, greater healing percentages and less recurrences. To our
knowledge, this has never been investigated before.

To assess the potential benefit of pelvic floor therapy for anal fissure.
Measured primarily in pain, measured by the VAS score. Secondary outcomes are
healing rates and recurrence.

Multicentre, stratified block-randomisation, non-blinded, parallel-group,
superiority designed study

Pelvic floor therapy. Consisting out of a weekly course for 3 weeks. Each
session takes about 30 minutes. General queries are asked to evaluate the
pelvic floor and general information is given about how the pelvic floor should
function. After that, relaxation exercises are given so that patients learn to
control their pelvic floor better and in turn, learn how to relax their pelvic
floor muscles.

The burden associated with participation are extra in-hospital visits. For
acute anal fissure, participants have 3 in-hospital visits (first appointment
for diagnosis, then 2 follow-up appointments). For chronic anal fissure,
participants have 4 in-hospital visits (first appointment for diagnosis, second
appointment for surgery + botulinum toxin injection in day care, and 2
follow-up appointments). Compared to usual care, this means one extra follow-up
appointment.

During the initial appointment and follow-up, participants will be questioned
and physically examined (inspection of the anus). Measurement of pain through
VAS scores can be managed at home and will take only a minute or so.
Measurement moments will be baseline and after treatment starts: day 1, 2, 3, 7
and weeks 2, 4, 8 and 12. In the 9th week, patients will return to clinic,
where they*ll be questioned and physically examined. In the 13th week after
treatment initiation patients will again return to clinic, for final
questioning and physical examination.

During the in-hospital visit in the 9th week, participants will be asked to
fill in a short questionnaire to evaluate how they experienced pelvic floor
therapy. This will take them only 5 minutes.

The burden associated with the investigational treatment pelvic floor therapy
will be a weekly course for 3 weeks. One sessions will last about 30 minutes.
Pelvic floor therapy will be given by certified pelvic floor therapists. There
are no risks associated with pelvic floor therapy. Pelvic floor therapy
provided in this study is without financial cost to the participant.