search
Back to results

Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence (Bulking)

Primary Purpose

Fecal Incontinence

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bulking agent
Endoanal electrostimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring fecal incontinence, anorectal manometry, bulking agents

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate fecal incontinence

Exclusion Criteria:

  • Severe fecal incontinence
  • Pelvic radiotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Bulking agent

    Endoanal electrostimulation

    Arm Description

    Bulking agent in fecal incontinence

    Endoanal electrostimulation in fecal incontinence

    Outcomes

    Primary Outcome Measures

    Fecal incontinence
    Score of Fecal Incontinence

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2017
    Last Updated
    February 5, 2018
    Sponsor
    University of Sao Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03052946
    Brief Title
    Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence
    Acronym
    Bulking
    Official Title
    A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 28, 2018 (Anticipated)
    Primary Completion Date
    November 30, 2019 (Anticipated)
    Study Completion Date
    March 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    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
    Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP). Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded. The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
    Detailed Description
    Prospective randomized trial Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP). Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded. The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fecal Incontinence
    Keywords
    fecal incontinence, anorectal manometry, bulking agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Bulking agents
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bulking agent
    Arm Type
    Active Comparator
    Arm Description
    Bulking agent in fecal incontinence
    Arm Title
    Endoanal electrostimulation
    Arm Type
    Placebo Comparator
    Arm Description
    Endoanal electrostimulation in fecal incontinence
    Intervention Type
    Procedure
    Intervention Name(s)
    Bulking agent
    Intervention Description
    Filling bulking agent in the anal canal
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoanal electrostimulation
    Intervention Description
    The technique used will be with a frequency of 30 to 40 Hz with pulse width of 200 ms with maximum intensity of 800mAmp and duration of 30 minutes
    Primary Outcome Measure Information:
    Title
    Fecal incontinence
    Description
    Score of Fecal Incontinence
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderate fecal incontinence Exclusion Criteria: Severe fecal incontinence Pelvic radiotherapy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

    We'll reach out to this number within 24 hrs