NON-ABLATIVE RADIOFREQUENCY IN FEMALE ANAL INCONTINENCE: PRELIMINARY RANDOMIZED CLINICAL TRIAL

Liony C1, Teles A1, Robatto M1, Alves R1, Pavie M1, Passos J1, Barros D1, Sodre P1, Alencar T1, Ianca B1, Januário P2, Vieira C1, Ananda Ellen R1, Lobo A1, Jatobá B1, Santana I1, Moura T1, Ventura D1, Brasil C1, Tulha A3, Lordelo P1

Research Type

Clinical

Abstract Category

Anorectal / Bowel Dysfunction

Abstract 757
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Anal Incontinence New Devices Clinical Trial
1.Pelvic Floor Care Center (CAAP), Bahiana School of Medicine and Public Health (EBMSP), 2.UNEB and Pelvic Floor Care Center (CAAP), Bahiana School of Medicine and Public Health (EBMSP), 3.UroFistiterapia Labaratory - Federal University of Alfenas
Links

Abstract

Hypothesis / aims of study
Hypothesis: Non-ablative radiofrequency is a new therapeutic possibility to treat anal incontinence, that may aid one of the factors of physiopathogenic mechanisms of the anal sphincter muscles, with collagen production and collapsing factors. The aim of the study was To verify the clinical response, fecal quality of life, adverse effects and manometry results of non-ablative radiofrequency to treat anal incontinence in women.
Study design, materials and methods
This was a randomized clinical trial developed with women with anal incontinence (AI), with muscular strength ≥ 3 (according to Oxford Grading System), aged between 18 and 65 years old, attended at the Pelvic Floor Care Center. Excluded were pregnant women, with impaired comprehension, with active hemorrhoidal disease and with metallic clamp. After the consent, an initial evaluation was performed, consisting of anamnesis, fecal and incontinence diaries, evaluation of pelvic floor function (PERFECT), anorectal manometry and application of Fecal Incontinence Quality of Life (FIQL), Modified Visual Analogue Scale (VAS). The women were randomized into two groups: the radiofrequency group (RG), in which 5 sessions of outpatient pelvic floor muscle training associated with the  non-ablative monopolar radiofrequency (RF), on the anal border (perianal), with a temperature of 39-41°C, for 2 minutes, were performed; control group (CG) followed the same protocol, but the RF was switched off with heated gel.  The pelvic floor muscle training protocol was composed of 20 contractions, each lasting five seconds and relaxing for five seconds. Right after, they should contract the pelvic floor muscles for 2 seconds, rest for 4 seconds, repeating it 20 minutes. Both groups performed home exercises. After one week of the last non-ablative RF session, the incontinence and fecal diaries, questionnaires, muscle function were reassessed, and the participants were asked about their satisfaction with the treatment (FIQL, VAS).
Results
The sample was composed of 15 women, 7 women in the RG and 8 in the GC. There was no statistical difference between the groups according  to the sociodemographic and clinical data.
Analyzing the incontinence diaries for gas, RG 85.7% (6) decreased flatus losses, six patients had complete loss resolution. In the CG, 37% (4) of the patients reduced gas losses, there was no complete resolution of the flatus loss, 3 patients increased gas losses. The RG showed a reduction of the gas losses. Patients from CG through FISI had a greater severity of incontinence prior to the treatment protocol, ranging from 40.0 (25.0-48.5) to 21.5 (16.0-34.0) (p = 0.381 ). In the RG, the severity was lower and ranged from 22.0 (12.0-49.0) to 20.0 (13.5-21.3) (p = 0.128). The two groups presented non-significant variation. There was no change in quality of life by the FIQL or in the manometric data.
Interpretation of results
In this study, the use of perianal RF is proposed as a new conservative and innovative technique in the treatment of AI. The research presented a reduction in anal gas incontinence in women with the use of the RF technique applied in the perianal region and no adverse effects were observed. This result probably represents a gain in passive continence, that is, an action on the mechanism of continence of the internal sphincter. There are no studies in the literature with evaluation of the consistency for gases with the use of RF.
Concluding message
The sample was composed of 7 women in the GR and 8 in the GC. The GR showed a reduction of the gas losses. There was no change in quality of life by the FIQL nor in the manometric data. Con-clusion: There was a reduction in the gas loss of women undergoing non-ablative radiofrequency on the anal edge. However, improving clinical symptoms did not im-prove the quality of life of these women.
Figure 1
References
  1. Lukban JC. Transurethral radiofrequency collagen desnaturation for treatment of female stress urinary incontinence: a review of the literature and clinical recommenda-tions. Obstetrics and Gynecology International 2012; 1-6.
  2. Herman R M, Berho M, Murawski M, Nowakawski M, Schwaz T, Wojtsiak D, Wexner SD. Defining the histopathological changes induced by nonablative radiofre-quency treatment of faecal incontinence- a blinded assessment in an animal model Colorectal disease, 2014. -The Association of coloproctolog of Great Britain na Irland 17, 433-440. DOI: 10.1111/codi.12874.
  3. Visscher AP, Lam TJMeurs-Szojda MM, Felt-Bersma RJ. Clinical response and sustainability of treatment with temperature-controlled radiofrequency energy (SECCA) in patients with faecal incontinence: 3 years follow-up. Int J Colorectal Dis (2014) 29:755–761 DOI 10.1007/s00384-014-1882-2.
Disclosures
Funding no Clinical Trial Yes Registration Number NTC: 03147729 RCT Yes Subjects Human Ethics Committee Escola Bahiana de Medicina e Saúde Pública Helsinki Yes Informed Consent Yes