Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study

Tjandra, Joe J.; Chan, Miranda K. Y.; Yeh, Chia-Yi; Murray-Green, Carolyn

doi:10.1007/s10350-007-9103-5

Cited by 243 publications

(152 citation statements)

References 33 publications

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“…In our long-term outcomes series, one patient who recently benefited from a sacral nerve stimulation device implantation was operated on by our pediatric surgical team together with an adult team before he was entrusted to the adult team. 38,39 We believe this is an important transition for all cases now.…”

Section: Dyssynergic Defecationmentioning

confidence: 84%

Interest of Anorectal Manometry During Long-term Follow-up of Patients Operated on for Hirschsprung's Disease

Tran

Mahler

Bontems

et al. 2018

J Neurogastroenterol Motil

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Background/AimsAlthough many advances in the management of Hirschsprung's disease have recently been achieved, postoperative outcomes of these patients remain difficult in a non-negligible number of cases. Therefore, this study aims at investigating characteristics of anorectal manometry and its relationship with postoperative outcomes during long-term follow-up in Hirschsprung patients. MethodsPatients over 4 years of age operated on for Hirschsprung's disease were interviewed to complete detailed questionnaires on bowel function. The patients who consented to undergo an anorectal manometry during follow-up were enrolled in this study. We investigated their clinical characteristics, manometric findings, and their postoperative bowel function. ResultsNineteen patients out of 53 patients (35.8%) were enrolled, 68.4% who were male. Mean age of patients at manometry was 11.3 ± 6.3 years. Twelve out of 19 patients (63.2%) were incontinent. The mean anal resting pressures of incontinent patients were significantly lower than continent patients (47 ± 12 mmHg versus 63 ± 11 mmHg, P < 0.05, t test). Due to neurological impairment, only 11 patients (57.9%) were able to perform a complete manometry. A dyssynergic defecation was found in 4 patients during strain tests. Maximum tolerated volume of the incontinent patients was significantly lower than that of the continent patients (97 ± 67 mL versus 181 ± 74 mL, P < 0.05, t test). ConclusionAnorectal manometry is an objective method providing useful information that could guide a more adapted management in patients with defecation disorders after Hirschsprung's disease operation.

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Section: Dyssynergic Defecationmentioning

confidence: 84%

Interest of Anorectal Manometry During Long-term Follow-up of Patients Operated on for Hirschsprung's Disease

Tran

Mahler

Bontems

et al. 2018

J Neurogastroenterol Motil

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“…[22][23][24][25][26][27][28] SNS has become the first-line surgical treatment option for FI. 17 Despite largely favourable data, SNS requires two operations and is not without risk of morbidity.…”

Section: Management Of Faecal Incontinencementioning

confidence: 99%

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Horrocks

Bremner

Stevens

et al. 2015

Health Technol Assess

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BackgroundFaecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted.ObjectivesTo assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.DesignMulticentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.SettingEighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.ParticipantsParticipants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.InterventionsPTNS was delivered via the Urgent®PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer’s protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation.Main outcome measuresOutcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs).ResultsIn total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28;p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta –2.3, 95% CI –4.2 to –0.3;p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark’s Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported.ConclusionsPTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI.Trial registrationCurrent Controlled Trials ISRCTN88559475.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

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“…53,54 All patients go through a test period of percutaneous nerve evaluation where a temporary electrode is inserted and connected to an external pulse generator. If this provides symptom improvement, an implantable pulse generator is inserted.…”

Section: Sacral Nerve Stimulatorsmentioning

confidence: 99%

Role of radiology in central nervous system stimulation

Minks

Pereira²,

Young³

et al. 2015

BJR

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Central nervous system (CNS) stimulation is becoming increasingly prevalent. Deep brain stimulation (DBS) has been proven to be an invaluable treatment for movement disorders and is also useful in many other neurological conditions refractory to medical treatment, such as chronic pain and epilepsy. Neuroimaging plays an important role in operative planning, target localization and post-operative follow-up. The use of imaging in determining the underlying mechanisms of DBS is increasing, and the dependence on imaging is likely to expand as deep brain targeting becomes more refined. This article will address the expanding role of radiology and highlight issues, including MRI safety concerns, that radiologists may encounter when confronted with a patient with CNS stimulation equipment in situ.Central nervous system (CNS) stimulation is becoming increasingly prevalent. Deep brain stimulation (DBS) has been proven to be an invaluable treatment for movement disorders and is also useful in many other neurological conditions refractory to medical treatment, such as chronic pain and epilepsy. Neuroimaging plays an important role in operative planning, target localization and post-operative follow-up. ANATOMY OF THE DEEP BRAIN NUCLEIThe basal ganglia are a complex group of anatomically and neurochemically interconnected structures whose role is the control of complex and intentional movements and to inhibit unwanted movements.1 They comprise the corpus striatum (caudate nucleus, nucleus accumbens and putamen), globus pallidus [external segment (GPe) and internal segment (GPi)], substantia nigra [compact part and reticular part (SNr)] and the subthalamic nucleus (STN) (Figure 1). The pedunculopontine nucleus is highly interconnected with the basal ganglia and is now considered by many to be part of this group. Disorders of the basal ganglia therefore manifest by movement, posture and muscle tone abnormalities.There are wider connections to other parts of the brain such as the thalamus, limbic cortex and prefrontal cortex. These highlight their role in cognition and emotion and explain their implication in some psychiatric disorders and the cognitive symptoms associated with movement disorders.It is these structures and their interconnected neighbours that are the targets for treatment by DBS. The STN is the most common target for DBS treatment because it is capable of treating the entire gamut of advanced Parkinson's disease symptoms, including tremor, rigidity, bradykinesia and drug-induced dyskinesia.2 DBS reduces the need for dopaminergic medication. The benefits are a reduction of motor signs and improvement of functionality in the off-medication phase, a reduction of the required medication dose and its associated complications, and an increased quality of life.3 The benefits usually persist for at least 2 years and can last for many more.The STN plays a key role in the basal ganglia-thalamocortical motor circuit (Figure 2). The striatum receives input from the cerebral cortex and direct pathway information pa...

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Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study

Abstract: Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy.

Cited by 243 publications

References 33 publications

Interest of Anorectal Manometry During Long-term Follow-up of Patients Operated on for Hirschsprung's Disease

Interest of Anorectal Manometry During Long-term Follow-up of Patients Operated on for Hirschsprung's Disease

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Role of radiology in central nervous system stimulation

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