Radiofrequency in Anal Incontinence: Randomized Clinical Trials

Escola Bahiana de Medicina e Saude Publica

Status: Unknown

Conditions: Radiation Exposure

Treatments: Radiation: Radiofrequency non ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03147729

CAAE: 43462915.8.0000.554 4

Details and patient eligibility

About

Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. Based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to correlate the anal incontinence severity and to evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a blind randomized clinical trial. For the collection of data it was used a fecal quality of life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI), the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises. It was accomplished in eight sections. As a result, it is expected the efficiency of the treatment of radiofrequency in the quality of life, in sexual function and in it's severity.

Enrollment: 100 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals between 18 and 66 years of age with a clinical complaint of Anal Incontinence and who agree to participate voluntarily in the research.

Exclusion criteria

• Individuals with cognitive impairment, use of pacemakers, women who use the Intra-Uterine Device (IUD) of copper, pregnant women, individuals who are taking vasodilators or anticoagulants and hemophiliacs, patients with cognitive deficits or psychiatric illness, patients with chronic neurological degenerative diseases and individuals with hemorrhoid metallic clamp.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Radiofrequency in anal incontinence: a pilot study

Other group

Description:

It will be a single arm study with a group of anal incontinence with 10 women with anal incontinence

Treatment:

Radiation: Radiofrequency non ablation