A short- and long-term follow-up study of intersphincteric NASHA Dx implants for fecal incontinence

Abstract

Background The bulking agent NASHA Dx injected into the submucosal layer is effective in the treatment of fecal incontinence (FI) at short-and medium-term follow-up but efficacy after injection in the intersphincteric location is unknown. The aim of this study was to determine the short- and long-term efficacy and safety of NASHA Dx injected into the intersphincteric location for FI. Methods Patients were recruited from referrals to our Department for treatment of FI in November 2008–January 2010. Eligible patients were injected with 8 ml of NASHA Dx. Patients with a subtotal treatment effect were retreated after 2–4 weeks. The change in number of fecal incontinence episodes, the proportion of responders defined as at least 50% decrease in number of FI episodes and side effects were the main outcome measures. Results Sixteen patients, 15 women and 1 man with a median age of 68, 5 (range 44–80) years and a median CCFIS of 15 (range 10–19) were included in the study. The median number of incontinence episodes decreased from 21.5 (range 8–61) at baseline to 10 (range 0–30) at 6 months (p = 0.003) and 6 (range 0–44) at 12 months (p = 0.05). The median number of incontinence episodes in the 11 patients completing the 10-year follow-up was 26.5 (range 0–68). The percentage of responders at 12 months and 10 years were 56% and 27%, respectively. Mild to moderate pain at the injection site was described by 69%. There was one case of mild infection, successfully treated with antibiotics and one implant had to be removed due to dislocation. Conclusions NASHA Dx as an intersphincteric implant improves incontinence symptoms in the short term with moderate side effects and can be used alone or as an adjunct to other treatment modalities. Long-term efficacy was observed in 27%.

Urethral Bulking

“…A study using a visualized endoscopic injection technique for NASHA/Dx to treat SUI had few complications compared with using the Implacer system 97 . It is currently FDA approved for fecal incontinence, as a prostatic spacer for XRT, and as a common cosmetic dermal filler with few adverse events 98–100 …”

“…97 It is currently FDA approved for fecal incontinence, as a prostatic spacer for XRT, and as a common cosmetic dermal filler with few adverse events. [98][99][100] Vinyl dimethyl polydimethylsiloxane (VPDMS), a 2-component silicone elastomer meant to increase durability of PDS, does not have FDA approval. A crosssectional study of patients treated with VPDMS recruited for a follow-up visit (mean follow-up time, 25 months) showed 60% of patients having some type of postoperative complication: 22% with retention, 15% with pain and dyspareunia.…”

Avaliação da qualidade de vida em pacientes submetidos a neuromodulação sacral para incontinência fecal

“…Porém Lacima e colaboradores mostram que pacientes com IF podem apresentar IU em até 70% dos casos 48 , já Roberts e colaboradores encontram a presença de IU em pacientes do sexo masculino em 51% dos casos e em mulheres em 59% dos casos de IF 49 . O tempo de seguimento do implante de NSM em nosso estudo foi de 36,3±17,1 meses, em estudo de Jottard e colaboradores o tempo de seguimento foi de 6 meses, Janssen e colaboradores obtiveram o tempo de seguimento de 85,2 meses, já em estudo de Ezra e colaboradores, o seguimento teve duração de 120 meses com início aos 12 meses em pacientes com IF [50][51][52] . O histórico obstétrico está fortemente relacionado aos casos de IF, onde a maioria das pacientes mulheres passaram por 2 ou mais gestações e foram submetidas a parto vaginal associado ou não à obesidade 53 .…”

Autotransplante anorretal em suínos: padronização do modelo e avaliação pós- operatória em trinta dias

“…12,39 Felizmente, a maioria dos casos é leve e responde de forma variável a uma abordagem clínica inicial com mudança comportamental, dieta, agentes formadores de bolo fecal e medicações (loperamida e antiespasmódico) associada ou não à fisioterapia pélvica ou biofeedback, sendo esta última recomendada universalmente como segunda linha terapêutica. [39][40][41][42][43][44][45] Procedimentos ambulatoriais e pouco invasivos como estimulação do nervo tibial (ENT), [46][47][48][49][50][51] aplicação de radiofrequência ("SECCA procedure"), [52][53][54] injeção de agentes de preenchimento [55][56][57] e de cilindros de poliacrilonitrila [58][59][60][61] vêm sendo estudados, porém sem vantagens comprovadas em estudos controlados ou apresentam resposta discreta e não sustentada ao longo do seguimento. Eles são aplicados em casos selecionados com lesão esfincteriana pequena e em protocolos de pesquisa.…”