Percutaneous tibial nerve stimulation of fecal incontinence: a multi center, randomized, placebo controlled study

Fecal incontinence is a complex problem. The social consequences of this
problem result in a lower quality of life. The exact prevalence of FI is
unknown, literature reports vary from 13-19%. There are variable treatment
options depending on the patient and the etiology of the FI. Dietary
manipulation, pharmacological intervention, pelvic floor physiotherapy, as well
as surgical interventions are currently used to treat FI.

A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS).
The nerves in the spine that control bowel function also have branches which go
to the ankle. Stimulating these nerves in the ankle has shown to be an
effective treatment for FI in the short-term. The treatment has been shown to
be safe and well tolerated by subjects with almost no morbidity in prior
urology trials.

The objective of this study is to show that the results of PTNS are based on
the treatment of electrical stimulation and not on a placebo effect with a sham
treatment.

This study is a multicenter, single-blinded, randomized, placebo-controlled
trial.
Physicians will recruit and inform prospective subjects in the outpatient
clinic about this study. Subjects who are interested in participating in this
study will be provided informed consent at a minimum of one week prior to study
treatment.
The study will be performed in a multicenter setting including, but not limited
to, Maastricht University Medical Center in the Netherlands as well as other
sites such as La Sapienza University hospital in Rome Italy, and the
CCDE-IMAD-Hôtel-Dieu in Nantes France.

Study duration will consist of 9 weeks for the treatment group and the sham
group. During the first 6 weeks, both groups will receive treatment or sham
sessions twice a week. After six weeks, treatment outcomes will be assessed by
the CCF-FI score, IBS, QoL questionnaires and a Global Impression of the
condition by the Subject and Physician. Subjects will also initiate a 3-week
bowel habit diary. During the following three weeks (weeks 7-9) the treatment
or sham sessions will be continued for once a week. After 9 weeks, at the
completion of the bowel habit diary, the outcomes will be assessed again with
the CCF-FI score, IBS and QoL questionnaires and a Global Impression of the
condition by the Subject and Physician. All subjects will be unblinded at the
conclusion of 9 weeks. Those who were randomized to the sham treatment will be
offered the same PTNS treatments as the treatment group twice a week for 6
weeks followed by three weeks of weekly treatment. If sham treatment was
successful patients will still be offered this PTNS treatment to provide
possible additional effect. This continued treatment will be at the patients
discretion. Analysis of this group will be at 15 and 18 weeks as compared to
their own parameters at baseline and after sham treatment.
Maintenance treatment schedule will start after week 6 for both of the
treatment groups and after week 15 for the patients originally in the sham
group who at their own discretion decided to continue PTNS treatment. Week 7-9
of the protocol are in fact part of the maintenance treatment and are blinded
in the original format.
Follow-up will be evaluated at six and twelve months using a bowel habit diary,
CCF-FI score, IBS, QoL questionnaires and a Global Impression of the condition
by the Subject and Physician.

The Urgent®PC device (Uroplasty, Geleen, The Netherlands) used to deliver PTNS
is a combination of lead set and stimulator components, including a 34-gauge
needle electrode, surface electrode, lead wire and hand-held pulse generator.
This device is CE marked and indicated for treatment of Fecal Incontinence,
urinary frequency, urinary urgency and urge incontinence. The low voltage
stimulator powered by a 9-volt battery has an adjustable current setting
ranging from 0 to 9 mA, a fixed pulse width of 200 microseconds and a frequency
of 20 Hz. The device produces an electrical impulse that accesses the sacral
nerve plexus via the tibial nerve.
The needle is inserted in both groups at the same location near the medial
malleolus (ankle). The location is about 5 cm cephalad of the medial malleolus
and about 2 cm posterior to the tibia. The needle is then advanced towards the
nerve. The needle will then be connected to the stimulator and correct
placement will be confirmed by increasing the stimulator setting until toe
flexion and/or sole twinkling are observed. For therapy in the treatment group,
the stimulator will be turned on for 30 minutes. In the sham group the
stimulator will be turned back to 0 mA and then turned on for 30 minutes to
activate the timer.

Prior studies revealed some adverse events that can occur. The most common
adverse event reported is bleeding at the needle entry site and numbness in the
treated leg after treatment persisting for several hours. There is a small risk
of infection at the needle site. These risks are low and if they occur they
are mild. No irreversible, serious adverse events have been reported with
PTNS. The benefit of this study will be an increase understanding of the
efficacy that PTNS provides in the treatment of FI. With this evidence, this
treatment may become incorporated into everyday practice.