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Clinical Trials/NCT03052946
NCT03052946
Unknown
Phase 2

A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence

University of Sao Paulo0 sites60 target enrollmentFebruary 28, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Fecal Incontinence
Sponsor
University of Sao Paulo
Enrollment
60
Primary Endpoint
Fecal incontinence
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 28, 2018
End Date
March 30, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leonardo Alfonso Bustamante

Surgeon research at the colon and rectum service. Gastroenterology Department

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Moderate fecal incontinence

Exclusion Criteria

  • Severe fecal incontinence
  • Pelvic radiotherapy

Outcomes

Primary Outcomes

Fecal incontinence

Time Frame: 6 months

Score of Fecal Incontinence

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