Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: Bulking agent
* Procedure: Endoanal electrostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate fecal incontinence Exclusion Criteria: Severe fecal incontinence Pelvic radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Bulking agents
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bulking agent<br>Bulking agent in fecal incontinence | Procedure: Bulking agent<br>* Filling bulking agent in the anal canal<br>|
| Placebo Comparator: Endoanal electrostimulation<br>Endoanal electrostimulation in fecal incontinence | Procedure: Endoanal electrostimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal incontinence | Score of Fecal Incontinence | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal incontinence, anorectal manometry, bulking agents