Randomized clinical trial of percutaneous tibial nerve stimulation <i>versus</i> sham electrical stimulation in patients with faecal incontinence

Wilt, A. A. van der; Giuliani, Giuseppe; Kubis, Caroline; Wunnik, B.P.W. van; Ferreira, Isabel; Breukink, Stéphanie O.; Lehur, P.‐A.; Torre, Filippo La; Baeten, C. G. M. I.

doi:10.1002/bjs.10590

Cited by 40 publications

(27 citation statements)

References 29 publications

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“… 33 The benefits of PTNS for people with faecal incontinence have been questioned 34 , 35 due to the lack of pronounced clinical effects compared with a sham treatment. 36 , 37 It has been concluded that PTNS is unlikely to be recommended over SNS. 35 However, in real life, patients may prefer treatments which are less effective (although well tolerated) before considering more effective options.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence

Hounsome

Roukas

2018

Therap Adv Gastroenterol

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Background:Subcutaneous sacral nerve stimulation is recommended by the United Kingdom (UK) National Institute for Health and Care Excellence (NICE) as a second-line treatment for patients with faecal incontinence who failed conservative therapy. Sacral nerve stimulation is an invasive procedure associated with complications and reoperations. This study aimed to investigate whether delivering less invasive and less costly percutaneous tibial nerve stimulation prior to sacral nerve stimulation is cost-effective.Methods:A decision analytic model was developed to estimate the cost-effectiveness of percutaneous tibial nerve stimulation with subsequent subcutaneous sacral nerve stimulation versus subcutaneous sacral nerve stimulation alone. The model was populated with effectiveness data from systematic reviews and cost data from randomized studies comparing both procedures in a UK National Health Service (NHS) setting.Results:Offering percutaneous tibial nerve stimulation prior to sacral nerve stimulation (compared with delivering sacral nerve stimulation straight away) was both more effective and less costly in all modeled scenarios. The estimated savings from offering percutaneous tibial nerve stimulation first were £662–£5,697 per patient. The probability of this strategy being cost-effective was around 80% at £20,000–£30,000 per quality-adjusted life-year (QALY).Conclusion:Our analyses suggest that offering patients percutaneous tibial nerve stimulation prior to sacral nerve stimulation can be both cost-effective and cost-saving in the treatment of faecal incontinence.

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Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence

Hounsome

Roukas

2018

Therap Adv Gastroenterol

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“…In Kohortenstudien wurden die Kurzzeiterfolge mit 59-71 % beschrieben, allerdings wurden diese Ergebnisse durch eine im Jahre 2015 veröffentlichte randomisierte Multicenterstudie infrage gestellt: Das Ergebnis (mindestens 50 %ige Reduktion der Stuhlinkontinenzepisoden) nach PTNS und einer Scheinbehandlung zeigte keinen signifikanten Unterschied (38 vs. 31 %, p = 0,396) [34]. Dieses Ergebnis wurde durch eine weitere aktuelle randomisiert kontrollierte Studie bestätigt [35]. Eine Ex-post-Subanalyse der Daten dieser multizentrischen Untersuchung deutet darauf hin, dass das Verfahren möglicherweise bei Drangstuhlinkontinenz effizienter sein kann [36].…”

Section: Perkutane N-tibialis-posterior-stimulation (Ptns)unclassified

Moderne Therapiestrategien bei Stuhlinkontinenz

2019

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Zusammenfassung Hintergrund Das Krankheitsbild der Stuhlinkontinenz ist häufig mit einem signifikanten Leidensdruck für die Betroffenen und einer Verschlechterung von deren Lebensqualität vergesellschaftet, weist eine unterschätzte Prävalenz auf und wird aufgrund des demografischen Wandels in Deutschland in Zukunft noch an Bedeutung gewinnen. Hinsichtlich der Therapie einer Stuhlinkontinenz haben sich in den letzten Jahren neue Techniken entwickelt, und die Evidenz zu bestehenden Methoden hat zugenommen. Ziel dieser Arbeit ist es, aktuelle Entwicklungen und neuere Behandlungskonzepte bei Stuhlinkontinenz zu beleuchten. Methoden und Ergebnisse Eine aktuelle Literaturanalyse bez. der Therapie von Stuhlinkontinenz wurde durchgeführt. Im Rahmen der konservativen Inkontinenztherapie haben sich Kombinationstherapien als besonders wirksam erwiesen. Unter den chirurgischen Maßnahmen haben Studien zum Langzeitverlauf in den letzten Jahren die Evidenz der sakralen Nervenstimulation und deren Stand als Erstlinientherapie bekräftigt. Die Sphinkteroplastik bleibt eine bewährte Therapieoption bei Inkontinenz infolge von Lücken des Analsphinkters. Die therapeutische Langzeiteffektivität ist gering. „Bulking agents“ stellen eine Alternative vor allem bei passiver Stuhlinkontinenz dar, obgleich die Evidenz aufgrund unterschiedlicher verwendeter Substanzen und Techniken und fehlender Langzeitergebnisse eingeschränkt ist. Zur Behandlung einer Stuhlinkontinenz im Rahmen einer maskierten Stuhlentleerungsstörung hat sich die ventrale Netzrektopexie etabliert. Schlussfolgerungen Das Spektrum der Therapieoptionen zur Behandlung der Stuhlinkontinenz entwickelt sich kontinuierlich. Es besteht Konsens hinsichtlich des Einsatzes konservativer Maßnahmen als Initialtherapie. Es sind aktuell nur relativ wenig bewährte chirurgische Methoden verfügbar. Die Entwicklung und Evaluation neuer Behandlungsansätze wie auch die weitere Verbesserung der Evidenz der Effektivität bestehender Therapieoptionen ist anzustreben.

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“…A systemic review, including six prospective studies of PTNS for treating FI, suggested PTNS results in significant improvements in 50-70% of patients. 8 Subsequently, two randomized controlled trials comparing PTNS with sham treatment yielded conflicting results, 9,10 although subgroup analysis in the negative trial has suggested benefit in patients with urge FI. In all of these studies, patients were required to fail conservative management, but not specifically anorectal biofeedback, before undergoing neuromodulation, and in none of the studies was PTNS evaluated in combination with BF.…”

Section: Introductionmentioning

confidence: 99%

A novel combined anorectal biofeedback and percutaneous tibial nerve stimulation protocol for treating fecal incontinence

Mazor

Prott

Sequeira

et al. 2020

Therap Adv Gastroenterol

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Background/Aims: Fecal incontinence (FI) is a common, debilitating condition that causes major impact on quality of life for those affected. Non-surgical treatment options include anorectal biofeedback therapy (BF) and percutaneous tibial nerve stimulation (PTNS), usually performed separately. The aims of the current study were to determine the feasibility, tolerability, safety, and efficacy of performing a combined BF and PTNS treatment protocol. Methods: Female patients with urge FI were offered a novel pilot program combining BF with PTNS. The treatment protocol consisted of 13 weekly sessions: an educational session, followed by 5 combined BF and PTNS sessions, 6 PTNS and a final combined session. Anorectal physiology and clinical outcomes were assessed throughout the program. For efficacy, patients were compared with BF only historical FI patients matched for age, parity, and severity of symptoms. Results: A total of 12/13 (93%) patients completed the full program. Overall attendance rate was 93% (157/169 sessions). Patient comfort score with treatment was rated high at 9.8/10 (SD 0.7) for PTNS and 8.6/10 (SD 1.7) for the BF component. No major side effects were reported. A reduction of at least 50% in FI episodes/week was achieved by 58% of patients by visit 6, and 92% by visit 13. No physiology changes were evident immediately following PTNS compared with before, but pressure during sustained anal squeeze improved by the end of the treatment course. Comparing outcomes with historical matched controls, reductions in weekly FI episodes were more pronounced in the BF only group at visit 6, but not week 13. Conclusions: In this pilot study, concurrent PTNS and anorectal biofeedback therapy has been shown to be feasible, comfortable, and low risk. The combined protocol is likely to be an effective treatment for FI, but future research could focus on optimizing patient selection.

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Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence

Cited by 40 publications

References 29 publications

Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence

Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence

Moderne Therapiestrategien bei Stuhlinkontinenz

A novel combined anorectal biofeedback and percutaneous tibial nerve stimulation protocol for treating fecal incontinence

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