Optimising Treatments for Faecal Incontinence
Primary Purpose
Faecal Incontinence, Pelvic Floor Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Renew VS PTNS
Sponsored by
About this trial
This is an interventional treatment trial for Faecal Incontinence
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Renew Anal Insert
Percutaneous tibial nerve stimulation
Arm Description
The device is intended for self-insertion through the anal canal aided by a fingertip applicator.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pain
Five-point visual analog scale (VAS) from 0 to 10
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.
Full Information
NCT ID
NCT04273009
First Posted
February 7, 2019
Last Updated
February 13, 2020
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04273009
Brief Title
Optimising Treatments for Faecal Incontinence
Official Title
Percutaneous Tibial Nerve Stimulation With the Renew Anal Plug Device for the Treatment of Faecal Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
August 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faecal Incontinence, Pelvic Floor Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients who have completed the treatment can switch to the other treatment offered.
Masking
ParticipantInvestigator
Masking Description
Both participants and first investigator will be masked from the actual treatment.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renew Anal Insert
Arm Type
Active Comparator
Arm Description
The device is intended for self-insertion through the anal canal aided by a fingertip applicator.
Arm Title
Percutaneous tibial nerve stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Renew VS PTNS
Intervention Description
These will be prescribed and applied as described above.
Primary Outcome Measure Information:
Title
Renew vs PTNS treatment
Description
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
Secondary Outcome Measure Information:
Title
Pain
Description
Five-point visual analog scale (VAS) from 0 to 10
Time Frame
3 months
Title
Severity of incontinence
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8416784
Citation
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
Results Reference
background
PubMed Identifier
12790954
Citation
Norton C, Kamm MA. Anal plug for faecal incontinence. Colorectal Dis. 2001 Sep;3(5):323-7. doi: 10.1046/j.1463-1318.2001.00257.x.
Results Reference
background
PubMed Identifier
28647458
Citation
Horrocks EJ, Chadi SA, Stevens NJ, Wexner SD, Knowles CH. Factors Associated With Efficacy of Percutaneous Tibial Nerve Stimulation for Fecal Incontinence, Based on Post-Hoc Analysis of Data From a Randomized Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1915-1921.e2. doi: 10.1016/j.cgh.2017.06.032. Epub 2017 Jun 21.
Results Reference
background
PubMed Identifier
30218632
Citation
Segal JP, Leo CA, Hodgkinson JD, Cavazzoni E, Bradshaw E, Lung PFC, Ilangovan R, Vaizey CJ, Faiz OD, Hart AL, Clark SK. Acceptability, effectiveness and safety of a Renew(R) anal insert in patients who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis. Colorectal Dis. 2019 Jan;21(1):73-78. doi: 10.1111/codi.14422. Epub 2018 Oct 8.
Results Reference
background
PubMed Identifier
33399411
Citation
Leo CA, Thomas GP, Hodgkinson JD, Leeuwenburgh M, Bradshaw E, Warusavitarne J, Murphy J, Vaizey CJ. Randomized Pilot Study: Anal Inserts Versus Percutaneous Tibial Nerve Stimulation in Patients With Fecal Incontinence. Dis Colon Rectum. 2021 Apr 1;64(4):466-474. doi: 10.1097/DCR.0000000000001913.
Results Reference
derived
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Optimising Treatments for Faecal Incontinence
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