Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Fecal Incontinence Clinical Trial

— Bulking  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03052946
• Other study ID #: 09082009
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: February 10, 2017
• Last updated: February 5, 2018
• Start date: February 28, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: February 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Moderate fecal incontinence

Exclusion Criteria:

• Severe fecal incontinence

• Pelvic radiotherapy

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Procedure:
• Bulking agent
Filling bulking agent in the anal canal
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal incontinence	Score of Fecal Incontinence	6 months