Radiofrequency in Anal Incontinence: Randomized Clinical Trials

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.

Study Overview

• Status: Unknown
• Conditions: Radiation Exposure
• Intervention / Treatment: Radiation: Radiofrequency non ablation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador/, BA, Brazil, 40290-000
      • Escola bahiana de Medicina e Saúde Pública

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Radiofrequency in anal incontinence: a pilot study; It will be a single arm study with a group of anal incontinence with 10 women with anal incontinence	Radiation: Radiofrequency non ablation; Use of radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness of radiofrequency in anal incontinence	The radiofrequency application protocol will be used in the form of a capacitive electric transfer, bipolar configuration, with the Tonderm brand, Spectra G2 model, which has two electrodes: one active, in the anal region, with liquid glycerin and another, dispersive, coupled to the patient's hip. The temperature will be measured through a digital thermometer with infra-red until it reaches 41°C and will be maintained for 2 minutes. It will use Consent form, questionnaire of socio-demographic data and basic anamnesis. Then Fecal Incontinence Quality of Life, Fecal Incontinence Severity Index and Female Sexual Function Index. After, a perineal physical evaluation will be performed by an experienced Physical Therapist. The professional will perform a perineal muscle strength test, reflex and sensitivity test. For the sensitivity evaluation will be used a digital osiometer. The patients will be divided into two groups.	8 radiofrequency sessions will be performed, with a 7 day interval between them. The session will be 20 minutes.Participants will be followed up for a minimum of 12 months.

Collaborators and Investigators

• Sponsor: Escola Bahiana de Medicina e Saude Publica

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): May 3, 2017
• Study Completion (Anticipated): December 30, 2017

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Fecal incontinence; Anal incontinence; Radiofrequency; Sexuality; Women sexual function
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: CAAE: 43462915.8.0000.554 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication in scientific articles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No