Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

NCT ID: NCT03052946

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2020-03-30

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

Conditions

Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bulking agent

Bulking agent in fecal incontinence

Group Type: ACTIVE_COMPARATOR

Bulking agent

Intervention Type: PROCEDURE

Filling bulking agent in the anal canal

Endoanal electrostimulation

Endoanal electrostimulation in fecal incontinence

Group Type: PLACEBO_COMPARATOR

Endoanal electrostimulation

Intervention Type: PROCEDURE

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

Interventions

Bulking agent

Filling bulking agent in the anal canal

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Moderate fecal incontinence

Exclusion Criteria

• Severe fecal incontinence
• Pelvic radiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Alfonso Bustamante

Surgeon research at the colon and rectum service. Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

09082009

Identifier Type: -

Identifier Source: org_study_id