Manometric and clinical effects of non-ablative radiofrequency on the perianal region for treating female anal incontinence: preliminary results of a randomized clinical trial

Liony C1, Estevam de Abreu G2, Silva L1, Teles A1, Gomes T1, Brasil C1, Lemos A1, Vilas Boas A1, Pires J3, Cerqueira M1, Sodre P4, Brim R1, Alvares C1, Murday A5, Lima A1, Reis A1, Dutra A1, Barros D6, Celino G1, Maia J1, Costa T1, Alves R1, Dantas L1, Lordelo P1

Research Type

Clinical

Abstract Category

Anorectal / Bowel Dysfunction

Abstract 560
ePoster 8
Scientific Open Discussion Session 36
On-Demand
Anal Incontinence New Devices Clinical Trial Conservative Treatment
1. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, 2. Escola Bahiana de Medicina e Saúde Pública, 3. Centro Universitário Estácio do Ceará, Faculdade IDE, 4. Universidade do Estado da Bahia, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, 5. União Metropolitana de Ensino e Cultura, 6. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, Hospital Santa Izabel
Presenter
A

Alcina Teles

Links

Abstract

Hypothesis / aims of study
The use of Non-Ablative Radiofrequency (NARF) for treating Anal Incontinence (AI) on humans is a safe, low cost, and innovative resource. NARF promotes collagen type I synthesis and increases the relationship between types I/III. The repercussion of this effect include promoting elastic resistance to traction, increasing mechanical stability of the tissues, a series of (possibly beneficial) alterations both morphological and compositional, without scar formation (1,2). This is the first study that aims to verify manometric and clinical responses of NARF in women with AI.
Study design, materials and methods
Randomized blind clinical trial. There were included women between 18-65 years old, with clinical complaint of AI (fezes and gas) confirmed by the Fecal Incontinence Severity Index (FIFI). Upon clinic evaluation, according to the Modified Oxford Scale, participants had muscular strength ≥ 3. Women with difficulty in comprehension; who were using a metallic anal clamp; with active hemorrhoids disease; and pregnant women were excluded from the study. For the sample calculation, the standard deviation (SD) of 11.7 and 11.8, with a power of 80% and a significance level of 5%. The difference estimated was considered 7, the study predicts a total of 46 patients (23 to each group). All participants provided written informed consent before any protocol procedures. After giving consent, a third person, who was not part of the research, performed the randomization, ensuring confidentiality of allocation. It was made in a random table, generated on the program available at the website www.random.org. The patients were divided into two groups, with allocation secrecy. Group 1, or Control Group (CG) was subjected to a functional pelvic floor muscle training (PFMT) program, but with perianal NARF turned off and with a preheated gel (with intent of blinding the patient). Group 2, or Radiofrequency Group (RG) – interventional group – went through a functional pelvic floor muscle training program, with an addition of monopolar NARF applied over the anal border (perianal), during 2 minutes, to the temperature of 39-41°C. At an initial evaluation, including anamnesis, fecal and incontinence diary, evaluation of pelvic floor function (PERFECT), anal manometry (AM) and the application of  Fecal Incontinence Quality of Life questionnaire (FIQL) and the Analogue Visual Scale (AVS). The patient was to grade the discomfort felt by AI in a scale of 0-10 according to the AVS scale – 0 referring to no discomfort, and 10 maximum  discomfort. The PFMT protocol was composed of 20 contractions, each during 5 seconds, and 5 seconds of relaxation. Promptly after the previous exercise, the participant should contract the pelvic floor for 2 seconds and relax for 4 seconds (repeating 20 times). Both groups exercised at home. A week after the last NARF session fecal and incontinence diary, questionnaires, and pelvic floor function were reevaluated and the participants were questioned about their satisfaction with the treatment (using FIQL and AVS) and repeated the anal manometry exam.
Results
The sample consisted of 15 women – 7 being on RG and 8 on CG – with no statistical clinical and sociodemographic data differences between groups. When analysing the gas incontinence diaries, 85.7% (6) of the RG presented decrease of gas loss. Three out of these six patients had complete resolution of gas loss. There was a decrease of gas loss in 37% (4) patients from CG; no complete resolution was observed, and 3 patients increased this loss (figure 1). The manometric results presented a variation on the Retal Capacity (RC) before and after treatment: RG from 120ml (100ml-180ml) to 200ml (160,0ml-220ml) (p=0,027); CG from 180ml (135-215ml) to 180 (135-197.5ml) (p=0.752) (Tabela 1). Avaliando os resultados manométricos, houve variação da Capacidade Retal (CR) antes e após o tratamento no GR 120,0ml (100,0ml-180,0ml) para 200,0ml (160,0ml-220ml) (p=0,027) no GC 180,0 (135,0-215,0) para 180,0 (135,0-197,5) (p=0,752) (Tabela 1).
Interpretation of results
This research suggests NARF to be a pioneer and conservative treatment for AI; possibly due to the remodeling of internal anal sphincter structure, the study shows promising results for the treatment of passive incontinence for gas (1,2,3). The mean gas loss in the beginning of therapy was greater in RG compared to CG (Figure 1). Furthermore, a significant variation on the results involving the Rectal Capacity (RC) values was observed in the RG. For this reason, we suggest to extend the future studies on NARF on patients with low RC.
Concluding message
The patients subjected to NARF on the anal border presented a reduction of gas loss, with no adverse effects. However, even with the reduction of said loss, these patients had no modification on their quality of life. The anorectal manometry exam, showed an increase of the RC values on the patients subjected to NARF.
Figure 1 Figure 1
Figure 2 Table 1
References
  1. Herman RM, Berho M, Murawski M, Nowakawski M, Schwaz T, Wojtsiak D, Wexner SD. Defining the histopathological changes induced by nonablative radiofrequency treatment of faecal incontinence- a blinded assessment in an animal model Colorectal disease, 2014. -The Association of coloproctolog of Great Britain and Ireland 17, 433-440. DOI: 10.1111/codi.12874.
  2. 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
  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 The study was founded through Public Notice N° 10/2014 of the Emerging Nucleus Support Program–PRONEM/FAPESB/CNPQ Clinical Trial Yes Registration Number Registered in the Clinical Trial, NCT03147729 RCT Yes Subjects Human Ethics Committee Ethics Committee of the Bahiana School of Medicine and Public Health Helsinki Yes Informed Consent Yes
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