Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence — Bulking  

Fecal Incontinence Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT03052946
• Study type: Interventional
• Source: University of Sao Paulo
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: February 28, 2018
• Completion date: March 30, 2020