Optimising Treatments for Faecal Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Patients who wish to change treatment before the study ends will be withdrawn from the study.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.

Official Title
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Percutaneous Tibial Nerve Stimulation With the Renew Anal Plug Device for the Treatment of Faecal Incontinence

Conditions
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Faecal Incontinence, Pelvic Floor Disorders

Intervention / Treatment
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* Device: Renew VS PTNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Passive or mixed faecal incontinence. Minimum two or more episodes of faecal incontinence per week as assessed by prospectively collected bowel diaries. Failed biofeedback, pelvic floor physiotherapy or other medical management. Able to self- administer the Renew™ Anal Insert. Competent and willing to fill in questionnaires and attend clinics throughout the study. Patient must be able to comprehend and informed consent prior to enrolment in the study. Exclusion Criteria: Pregnancy. Inability to given informed consent. Perianal sepsis. Rectal bleeding. Inflammatory bowel disease/ Proctitis. Rectal prolapse. Third or fourth-degree hemorrhoids. Anal stricture. Anal or Recto-vaginal fistula. Rectal surgery in the past 3 months. Known allergy to Silicone. Patients who are mentally or physically unable to comply with the protocol of the study. The presence of any other medical condition which, in the opinion of the Chief Investigator, deems the patient unsuitable for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients who have completed the treatment can switch to the other treatment offered.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renew Anal Insert<br>The device is intended for self-insertion through the anal canal aided by a fingertip applicator. | Device: Renew VS PTNS<br>* These will be prescribed and applied as described above.<br>|
| Active Comparator: Percutaneous tibial nerve stimulation<br>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. | Device: Renew VS PTNS<br>* These will be prescribed and applied as described above.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Five-point visual analog scale (VAS) from 0 to 10 | 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. | 3 months |