Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 30, 2019

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

Interventions

  • Procedure: Bulking agent
    • Filling bulking agent in the anal canal
  • Procedure: Endoanal electrostimulation
    • 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

Arms, Groups and Cohorts

  • Active Comparator: Bulking agent
    • Bulking agent in fecal incontinence
  • Placebo Comparator: Endoanal electrostimulation
    • Endoanal electrostimulation in fecal incontinence

Clinical Trial Outcome Measures

Primary Measures

  • Fecal incontinence
    • Time Frame: 6 months
    • Score of Fecal Incontinence

Participating in This Clinical Trial

Inclusion Criteria

  • Moderate fecal incontinence Exclusion Criteria:

  • Severe fecal incontinence – Pelvic radiotherapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Leonardo Alfonso Bustamante, Surgeon research at the colon and rectum service. Gastroenterology Department – University of Sao Paulo

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