The purpose of the study is to directly compare two medical treatments for faecal incontinence: Renew™ Anal Insert and Percutaneous Tibial Nerve Stimulation (PTNS) for a period of 12 weeks. Both are routinely used in our practice.
The Renew™ anal insert is a new single-use anal device, CE marked and widely used in the UK and Europe. It is indicated for the management of faecal incontinence and designed to seal and prevent the involuntary passage of stool from the rectum. The device is intended for self-insertion aided by a fingertip applicator. Percutaneous tibial nerve stimulation (PTNS) is a form of electrical stimulation that offers a simple minimally invasive outpatient treatment for faecal incontinence. A fine needle is inserted next to the tibial nerve above the ankle, a ground pad is attached to the heel and electric current just strong enough to cause minor tingling is passed between these two points. The treatment requires 12 outpatients sessions that are 30 minutes long each time and the treatment may be repeated. Patients will be randomly allocated to either receive PTNS therapy or the Renew™ device. This will be done by the investigators randomly selecting a sealed envelope that is not see-through from a large number of identical envelopes. Each of these envelopes will contain either the word PTNS or the word Renew, which will then determine patients' treatment. There will be an equal number of PTNS and Renew envelopes to make this decision truly random. The principal investigator of this study will not know which treatment patients have been allocated to until after the study is complete. Patients who wish to change treatment before the study ends will be withdrawn from the study. During the study the investigators will ask patients to complete some standard questionnaires that are normally used to score the degree of the incontinence and to assess bowel symptoms.: These will be completed at the hospital during the standard clinic consultation, both before patients start the treatment and after having completed the treatment course.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
These will be prescribed and applied as described above.
Renew vs PTNS treatment
A consecutive two weeks bowel diaries at 3 months follow up Use of PTNS or RENEW Frequency of episodes of faecal incontinence
Time frame: 3 months
Pain
Five-point visual analog scale (VAS) from 0 to 10
Time frame: 3 months
Severity of incontinence
This will be measured using a single validated outcome measure valued in score (St Mark's faecal incontinence score): this measure in a grade from 0 to 4, the number of episodes of incontinence to solid stools, the number of episodes of incontinence to liquid stools, the number of episodes of incontinence to flatus (gas). It also measures in a grade from 0 to 4 the frequency of the use of pads and the frequency of use constipating medicines. The sum of the numbers will give a final score which will be used as method to measure the severity of incontinence.
Time frame: 3 months
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