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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
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Faecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 7, 2019
    Last Updated
    February 13, 2020
    Sponsor
    London North West Healthcare NHS Trust
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    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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