Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Last updated: February 5, 2018
Sponsor: University of Sao Paulo
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Rectal Disorders

Fecal Incontinence

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT03052946
09082009
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate fecal incontinence

Exclusion

Exclusion Criteria:

  • Severe fecal incontinence

  • Pelvic radiotherapy

Study Design

Total Participants: 60
Study Start date:
February 28, 2018
Estimated Completion Date:
March 30, 2020

Study 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