Neuroestimulación/neuromodulación sacra en incontinencia fecal y/o urinaria / Sacral neurostimulation/neuromodulation in fecal and/or urinary incontinence

CONTEXTO: La incontinencia urinaria (IU), o trastorno del vaciado vesical, se define como la incapacidad de mantener un control de la micción. Los trastornos del vaciado vesical se dividen en cuatro tipos generalmente, éstos son: IU de urgencia (generalmente asociado al síndrome de vejiga hiperactiva); IU de esfuerzo (pérdida de orina asociado al ejercicio, al toser o estornudar); IU mixta (combinación de las dos previas) y finalmente la IU por rebosamiento o retención urinaria no obstructiva. Las estimaciones de prevalencia de estas afectaciones varían debido a las diferencias en las definiciones, pero se ha reportado hasta un 55% en mujeres adultas. La IU de urgencia y la de esfuerzo son los tipos más frecuentes de IU crónica, con una prevalencia del 31% en mujeres mayores de 75 años y de 24 a 45% en mujeres mayores de 30 años, respectivamente. Tanto los hombres como las mujeres se ven afectados, siendo las mujeres más propensas a experimentar la incontinencia. TECNOLOGÍA: La neuromodulación sacra consiste en un generador de pulsos implantable que suministra impulsos eléctricos controlados. El dispositivo utilizado para conseguir la estimulación cuenta con un generador el cual está conectado a cables que conectan con los nervios sacros, generalmente a nivel de la raíz de S3. Dos componentes externos del dispositivo ayudan a controlar la estimulación eléctrica: um magneto de control es accionado por el paciente para prender y apagar el dispositivo y una consola programadora puede ser utilizada por el médico para ajustar los pulsos del generador. Los pacientes deben poder operar el dispositivo y llevar un diario de evacuaciones. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de neuroestimulación/ neuromodulador em incontinencia fecal y/o urinaria. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y políticas de cobertura de diferentes sistemas de salud. RESULTADOS: Se incluyeron cinco RS, tres estudios prospectivos no controlados, cinco GPC, una evaluación económica, y 26 informes de políticas de cobertura neuromodulación sacra en incontinencia fecal y/o urinaria. CONCLUSIÓN: Evidencia de moderada calidad sugiere que la terapia con neuromodulación sacra, en comparación con otras alternativas terapéuticas, podría reducir el número de eventos de incontinencia urinaria y mejorar la calidad de vida de adultos que han fallado a otras líneas de tratamiento conservador, estos resultados fueron observados en el corto y mediano plazo. Evidencia de moderada calidad sugiere que la terapia con neuromodulación sacra, en comparación con la estimulación del tibial posterior, podría reducir el número de eventos de incontinencia fecal en adultos que han fallado a otras líneas de tratamiento conservador, estos resultados fueron observados en el corto y mediano plazo. Evidencia de muy baja calidad no permite evaluar la eficacia y seguridad de neuromodulación sacra en pacientes pediátricos con incontinencia fecal. Evidencia de muy baja calidad, proveniente de dos series de casos, no permiten sacar conclusiones acerca de la eficacia y seguridad de la neuroestimulación sacra en pacientes adultos com coexistencia de incontinencia fecal y urinaria. Las guías de práctica clínica que han sido relevadas sobre incontinencia fecal o incontinência urinaria contemplan a la neuromodulación sacra como una alternativa terapéutica en tercera línea de tratamiento. Las políticas de cobertura que han sido relevadas en América Latina no mencionan la cobertura de esta tecnología. Los financiadores públicos de Francia, Australia, Estados Unidos, Reino Unido y los privados de Estados Unidos que han sido relevados brindan cobertura de esta tecnología para las dos indicaciones evaluadas. No se hallaron estudios económicos realizados en Argentina que permitan conocer la costo-efectividad y/o el impacto presupuestario de esta tecnología.

New treatment for faecal incontinence using zinc-aluminium ointment: a double-blind randomized trial.

AIM: In a randomized double-blind study the therapeutic effect of a novel zinc-aluminium ointment was compared with placebo in patients with faecal incontinence. METHOD: A randomized double-blind trial was performed. Patients who met the inclusion criteria were randomized to receive the ointment or a placebo. All were evaluated prior to and 3 weeks after ointment application, using the Wexner incontinence score and the Fecal Incontinence Quality of Life (FIQL) score. RESULTS: Fifty patients were randomized and six were lost to follow-up, leaving 24 in the treatment and 20 in the placebo group. The average ages were 61.3 and 60.7 years. The respective Wexner scores prior to intervention were 16.6 and 16.7. They decreased significantly after treatment to 8.5 and 13.1 (P<0.001 and P=0.002 respectively). There was a significant difference in the final scores, favouring the treatment group (P=0.001). The FIQL scores for the treatment group were also significantly better in all parameters compared with those of the placebo group. CONCLUSION: The study shows that the zinc-aluminium based ointment decreases faecal incontinence significantly compared with placebo.

[Prospective, double-blind study of topical phenylephrine treatment for nocturnal fecal incontinence in patients after ileoanal pouch construction]. / Estudio prospectivo y doble ciego del tratamiento local con fenilefrina de la incontinencia anal nocturna en pacientes con reservorio ileal.

PATIENTS: Fecal incontinence has been reported in 5.5% to 45% of patients after ileoanal pouch construction, predominantly at night. It has been shown that alpha1-adrenergic agonists as phenylephrine increase anal sphincter pressure in healthy volunteers and in patients with idiopathic fecal incontinence. The median duration of action of topical phenylephrine is seven hours. Carapeti et al have demonstrated its usefulness in patients after ileoanal pouch construction. OBJECTIVE: To demonstrate that the administration of a single dose of topical 10% phenylephrine at night is effective for the treatment of nocturnal anal incontinence in this group of patients. PATIENTS AND METHODS: We randomized 12 patients in two groups. Group A (control) received a placebo cream and group B received a 10% phenylephrine cream. The study was prospective, randomized and double-blind. RESULTS: There were no significant differences between the two groups in age, follow-up time since the closure of ileostomy and pre-treatment and intra-treatment leaks. Control group had 7 episodes of incontinence pre-treatment and 9 intra-treatment. Treated group had 3 and 5.4, respectively. (p = NS) No patient had side effects. CONCLUSIONS: Given the small number of patients included, we can not yet rule out that topical 10% phenylephrine is useful for the treatment of nocturnal fecal incontinence in patients after ileoanal pouch construction. It would be necessary to continue with studies, increasing the number of patients treated with this drug, in order to have a better evidence of its clinical utility.

Are topical oestrogens useful in faecal incontinence? Double-blind randomized trial.

BACKGROUND: Histopathological studies have shown the presence of oestrogenic receptors in the anal sphincter, which presumes a role in muscular trophism for circulating oestrogens. This could explain the increase in faecal incontinence (FI) in postmenopausal women. OBJECTIVE: To evaluate the effect of topical oestrogens (TE) in controlling symptoms of FI in postmenopausal women. Hypothesis The application of TE in postmenopausal women with FI improves continence. METHOD: We performed a prospective double-blind randomized trial applying TE to the anal mucosa in postmenopausal women with FI. STUDY PERIOD: 2005-2006. The patients were randomized into two groups: I--topical estriol, II--placebo. In both groups, the ointment was applied three times daily for a period of 6 weeks. We compared Wexner's FI score and the FI quality of life scale, before commencing and after 6 weeks of application. RESULTS: In this period we evaluated 36 patients. Average age: 67 years (48-84). Group I: 18 patients and group II: 18 patients, one patient was excluded. Wexner's FI score in group I was 11 (5-18) and 7 (0-19) with pre- and postapplication respectively (P = 0.002). Wexner's FI score in group II was 12 and 9 with pre- and postapplication respectively (P = 0.013). When we compared the results between both groups, this was not statistically significant (P = 0.521). CONCLUSION: There is improvement of continence in both groups that had the ointment applied; nonetheless this study could not show that TE improves FI more than a placebo does.

[Current concepts in the pathophysiology, diagnosis and treatment of fecal incontinence]. / Novedades en la fisiopatología. Diagnóstico y tratamiento de la incontinencia fecal.

Fecal incontinence (FI), defined as the recurrent uncontrolled passage of fecal material due to the inability to control bowel discharge is a common and devastating condition. According to previous studies, at least 1 in 10 adult women have FI. This disorder poses a significant economic burden and has a negative impact on patient's lifestyle, leads to a loss of self-confidence, social isolation and a diminished quality of life. Three subgroups of FI are recognized: a) passive incontinence: the involuntary discharge of stool or gas without awareness; b) urge incontinence: the discharge of fecal matter in spite of active attempts to retain bowel contents, and c) fecal seepage: the involuntary leakage of small volumes of stool after normal evacuation. Disruption of the normal structure or function of the anorectal unit leads to FI and is often due to multiple mechanisms. A detailed history and examination including digital rectal examination facilitates diagnosis. Anorectal physiological tests provide useful information regarding functional abnormalities and anal endosonography regarding sphincter defects. These tests provide insights regarding pathophysiology and can guide further management. Behavioral therapy is successful in most patients and should be offered first. Surgical treatment should be considered in cases who fail medical treatment or with sphincter defects. Several experimental approaches, including bulking of the anal sphincter, sacral nerve stimulation and the delivery of radiofrequency energy to the anal canal are under investigation.