Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence (Bulking)
Primary Purpose
Fecal Incontinence
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bulking agent
Endoanal electrostimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring fecal incontinence, anorectal manometry, bulking agents
Eligibility Criteria
Inclusion Criteria:
- Moderate fecal incontinence
Exclusion Criteria:
- Severe fecal incontinence
- Pelvic radiotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bulking agent
Endoanal electrostimulation
Arm Description
Bulking agent in fecal incontinence
Endoanal electrostimulation in fecal incontinence
Outcomes
Primary Outcome Measures
Fecal incontinence
Score of Fecal Incontinence
Secondary Outcome Measures
Full Information
NCT ID
NCT03052946
First Posted
February 10, 2017
Last Updated
February 5, 2018
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03052946
Brief Title
Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Anticipated)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
fecal incontinence, anorectal manometry, bulking agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Bulking agents
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bulking agent
Arm Type
Active Comparator
Arm Description
Bulking agent in fecal incontinence
Arm Title
Endoanal electrostimulation
Arm Type
Placebo Comparator
Arm Description
Endoanal electrostimulation in fecal incontinence
Intervention Type
Procedure
Intervention Name(s)
Bulking agent
Intervention Description
Filling bulking agent in the anal canal
Intervention Type
Procedure
Intervention Name(s)
Endoanal electrostimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Fecal incontinence
Description
Score of Fecal Incontinence
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate fecal incontinence
Exclusion Criteria:
Severe fecal incontinence
Pelvic radiotherapy
12. IPD Sharing Statement
Plan to Share IPD
No
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Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence
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