Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

University of Sao Paulo

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Fecal Incontinence

Treatments: Procedure: Bulking agent; Procedure: Endoanal electrostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03052946

09082009

Details and patient eligibility

About

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 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate fecal incontinence

Exclusion criteria

• Severe fecal incontinence
• Pelvic radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Bulking agent

Active Comparator group

Description:

Bulking agent in fecal incontinence

Treatment:

Procedure: Bulking agent

Endoanal electrostimulation

Placebo Comparator group

Description:

Endoanal electrostimulation in fecal incontinence

Treatment:

Procedure: Endoanal electrostimulation