Implantable and Programmable Sacral Neuromodulator (Interstim®) Treatment of Urinary, Fecal and Combined Incontinence

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A; URTASUN, M

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Urinary incontinence (UI) is the incapacity to keep the urinary function under control. Its cause maybe neurogenic or idiopathic, and approximately 16% of adults suffer it and approximately 30% donot respond to standard treatment. Fecal incontinence (FI) is the lack of bowel movement control,and its prevalence ranges between 6% and 15%. In half of the FI cases there is also associatedUI. Due to its high prevalence and standard treatment failure rate, sacral neuromodulation (SNM)with InterStim® is proposed for urinary, fecal or combined incontinence.TechnologySNM is a device placed at sacral level (InterStim®; System for Urinary Control, Medtronic, Inc.,Minneapolis, MN) which generates controlled electrical impulses on the nerve to regulate bladderemptying, the anal sphincter and the pelvic floor muscles. It is indicated for the treatment of UI orFI in patients refractory to standard treatment with a satisfactory response to percutaneousstimulation.PurposeTo evaluate the available evidence on the efficacy, safety and issues related with coveragepolicies for the use of implantable and programmable sacral neuromodulation (InterStim®) inpatients with urinary, fecal or combined incontinence.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internetgeneral search engines, in health technology evaluation agencies and health sponsors. Prioritywas given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs);health technology assessments and economic evaluations; clinical practice guidelines andcoverage policies of other health systems.ResultsFive SRs, two RCTs, four case series, one consensus, three health technology assessments,three clinical practice guidelines (CPGs) and thirteen coverage policies on SNM were included.Urinary Incontinence (UI): Two SRs and one RCTs were identified.One SR evaluated the efficacy of an early vs. late implant for idiopathic UI; it included seven RCTs(n=11 to 98). No summary information was reported. An improvement favoring the early implant at6 months in the number of urine losses- range of mean differences between -3.6 and -9.8-; diaperuse in 24 hours - range of mean differences between -5.2 and -6.1- percentage of patients withoutlosses - range between RR 14.56 y RR 40.5. In patients with urinary retention, losses and dailyurinary catheterization decreased significantly. No significant differences were found in quality oflife.IECS ? INSTITUTO DE EFECTIVIDAD CLÍNICA Y SANITARIA - WWW.IECS.ORG.ARDocumentos de Evaluación de Tecnologías Sanitarias ? pág. 8Another SR evaluated the efficacy and safety for neurogenic UI. It included 26 heterogeneousstudies (n=357 adults) of moderate quality. The rate of success of the testing phase was 68% (CI95% 50% to 85%). The rate of success with permanent implant was 92% (CI 95% 81% to 98%).One RCT evaluated the efficacy of SNM for neurogenic UI in 42 children versus standardtreatment, but no significant differences were found.Fecal Incontinence (FI): Two SRs were identified in adults, the first one about the efficacy of SNMand four case series published at a later date and the second SR about the perioperative effects ofSNM.The SR on efficacy for chronic FI in adults included three heterogeneous crossover studies. Afterfive years of follow-up, the 26% treated with SNM achieved cure. The rest of the results were notsignificant.Four case series (n=19 to 133) evaluated the effectiveness of SNM in chronic FI, reporting somebenefits in FI episodes at short term, urgency and quality of life. One of them, found a significantdecrease in FI episodes at four years. Another case series reported that 41% of the patientsachieved 100% continence after 12 months.