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Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic floor rehabilitation
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring anorectal physiology, therapies, quality fo life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age higher than 18
  • To be woman
  • Have had incontinence episiodes at least from 6 month since the beginning of the study
  • Have had incontinence episodes during the last month prior the beginning of the study
  • The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Have very mild condition (Wexner <4)
  • To be unable to perform / understand the treatments properly
  • Being pregnant
  • To have used treatmets for fecal incontinence within the last six months prior to the start of the study
  • If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Kegel exercises

    biofeedback

    electrostimulation

    transcutaneous neuromodulation

    Arm Description

    Pelvic floor exercises designed in the 1950s' by Arnold Kegel.

    Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.

    Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.

    Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes

    Outcomes

    Primary Outcome Measures

    clinical severity
    severity of the symptoms measured with Cleveland score
    maximum anal resting pressure
    pressure of the anal canal measured with mmHg
    maximum squeeze pressure
    pressure on the anal canal when squeezing measured with mmHg
    rectal sensitivity
    patient's rectal perception, measured with cm3 of distention of a rectal balloon

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2017
    Last Updated
    January 8, 2018
    Sponsor
    Hospital de Mataró
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03394794
    Brief Title
    Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
    Official Title
    Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2013 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    March 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital de Mataró

    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
    This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.
    Detailed Description
    Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak. The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL. This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fecal Incontinence
    Keywords
    anorectal physiology, therapies, quality fo life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kegel exercises
    Arm Type
    Active Comparator
    Arm Description
    Pelvic floor exercises designed in the 1950s' by Arnold Kegel.
    Arm Title
    biofeedback
    Arm Type
    Experimental
    Arm Description
    Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility.
    Arm Title
    electrostimulation
    Arm Type
    Experimental
    Arm Description
    Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility.
    Arm Title
    transcutaneous neuromodulation
    Arm Type
    Experimental
    Arm Description
    Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes
    Intervention Type
    Device
    Intervention Name(s)
    Pelvic floor rehabilitation
    Intervention Description
    The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
    Primary Outcome Measure Information:
    Title
    clinical severity
    Description
    severity of the symptoms measured with Cleveland score
    Time Frame
    Changes of severity after 3 month-treatment
    Title
    maximum anal resting pressure
    Description
    pressure of the anal canal measured with mmHg
    Time Frame
    Changes maximum anal resting pressure after 3 month-treatment
    Title
    maximum squeeze pressure
    Description
    pressure on the anal canal when squeezing measured with mmHg
    Time Frame
    Changes maximum squeeze pressure after 3 month-treatment
    Title
    rectal sensitivity
    Description
    patient's rectal perception, measured with cm3 of distention of a rectal balloon
    Time Frame
    changes in rectal balloon filling after 3 month-treatment

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age higher than 18 To be woman Have had incontinence episiodes at least from 6 month since the beginning of the study Have had incontinence episodes during the last month prior the beginning of the study The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation. Exclusion Criteria: Not meeting inclusion criteria Have very mild condition (Wexner <4) To be unable to perform / understand the treatments properly Being pregnant To have used treatmets for fecal incontinence within the last six months prior to the start of the study If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women

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