Radiofrequency in Anal Incontinence: Randomized Clinical Trials

NCT03147729 | Unknown DMC

• 1 other identifier: CAAE: 43462915.8.0000.554 4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation Exposure

Keywords

Radiofrequency; Anal incontinence; Fecal incontinence; Women sexual function; Sexuality

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Radiofrequency in anal incontinence: a pilot study

OTHER

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

Radiation: Radiofrequency non ablation

Interventions

Radiofrequency non ablation RADIATION

Use of radiofrequency

Radiofrequency in anal incontinence: a pilot study

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Bahiana de Medicina e Saude Publica: lead

Study Sites (1)

Escola bahiana de Medicina e Saúde Pública

Salvador, Estado de Bahia, 40290-000, Brazil

Location

MeSH Terms

Conditions

Encopresis; Fecal Incontinence; Sexuality

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Sexual Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 10, 2017
• Study Start: June 1, 2015
• Primary Completion: May 3, 2017
• Study Completion: December 30, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)