Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Phase 2

• Conditions: Fecal Incontinence
• Interventions: Procedure: Bulking agent; Procedure: Endoanal electrostimulation

• Registration Number: NCT03052946
• Lead Sponsor: University of Sao Paulo

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06
• Study Start: 2018-02-28
• Primary Completion: 2019-11-30
• Study Completion: 2020-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Moderate fecal incontinence

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Exclusion Criteria

• Severe fecal incontinence
• Pelvic radiotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bulking agent	Bulking agent	Bulking agent in fecal incontinence
Endoanal electrostimulation	Endoanal electrostimulation	Endoanal electrostimulation in fecal incontinence

Primary Outcome Measures

Name	Time	Method
Fecal incontinence	6 months	Score of Fecal Incontinence