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).
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.