Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

NCT03052946 | Unknown Phase 2

• 1 other identifier: 09082009
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Fecal Incontinence

Keywords

fecal incontinence, anorectal manometry, bulking agents

Outcome Measures

Primary Outcomes (1)

• Fecal incontinence

  Score of Fecal Incontinence

  6 months

Study Arms (2)

Bulking agent

ACTIVE COMPARATOR

Bulking agent in fecal incontinence

Procedure: Bulking agent

Endoanal electrostimulation

PLACEBO COMPARATOR

Endoanal electrostimulation in fecal incontinence

Procedure: Endoanal electrostimulation

Interventions

Bulking agent PROCEDURE

Filling bulking agent in the anal canal

Bulking agent

Endoanal electrostimulation 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

Endoanal electrostimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate fecal incontinence

You may not qualify if:

• Severe fecal incontinence
• Pelvic radiotherapy

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon research at the colon and rectum service. Gastroenterology Department

Model Details: Bulking agents

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: February 28, 2018
• Primary Completion: November 30, 2019
• Study Completion: March 30, 2020
• Last Updated: February 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share