Optimising Treatments for Faecal Incontinence

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Patients who wish to change treatment before the study ends will be withdrawn from the study.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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04273009
Study type	Interventional
Source	London North West Healthcare NHS Trust
Contact
Status	Completed
Phase	N/A
Start date	December 15, 2016
Completion date	September 11, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.