Radiofrequency in Anal Incontinence: Randomized Clinical Trials

Radiation Exposure Clinical Trial

Official title:

Radiofrequency in Anal Incontinence: Randomized Clinical Trials

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03147729
• Other study ID #: CAAE: 43462915.8.0000.554 4
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 4, 2017
• Last updated: May 8, 2017
• Start date: June 1, 2015
• Est. completion date: December 30, 2017

Study information

• Verified date: May 2017
• Source: Escola Bahiana de Medicina e Saude Publica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 30, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence
• Radiation Exposure

Intervention

Radiation:
• Radiofrequency non ablation
Use of radiofrequency

Locations

Country	Name	City	State
Brazil	Escola bahiana de Medicina e Saúde Pública	Salvador/	BA

Sponsors (1)

Lead Sponsor	Collaborator
Escola Bahiana de Medicina e Saude Publica

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.