Optimising Treatments for Faecal Incontinence

February 13, 2020 updated by: London North West Healthcare NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Patients who wish to change treatment before the study ends will be withdrawn from the study.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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renew vs PTNS treatment
Time Frame: 3 months
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
Time Frame: 3 months
Five-point visual analog scale (VAS) from 0 to 10
3 months
Severity of incontinence
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2016

Primary Completion (Actual)

August 11, 2018

Study Completion (Actual)

September 11, 2018

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/LO/1821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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