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Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03052946
Acronym
Bulking
Enrollment
60
Registered
2017-02-14
Start date
2018-02-28
Completion date
2020-03-30
Last updated
2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

Keywords

fecal incontinence, anorectal manometry, bulking agents

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

Interventions

PROCEDUREBulking agent

Filling bulking agent in the anal canal

PROCEDUREEndoanal 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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Bulking agents

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Moderate fecal incontinence

Exclusion criteria

* Severe fecal incontinence * Pelvic radiotherapy

Design outcomes

Primary

MeasureTime frameDescription
Fecal incontinence6 monthsScore of Fecal Incontinence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026