Double-blind crossover study of sacral nerve stimulation for fecal incontinence

Vaizey, C. J.; Kamm, Michael A.; Roy, A J; Nicholls, R. J.

doi:10.1007/bf02258292

Cited by 141 publications

(119 citation statements)

References 13 publications

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“…This finding agrees with a previous similar study in patients treated with SNS for incontinence. 14 However, the numbers were small, due to limited numbers of patients who have clinical benefit at sub-sensory stimulation levels. Further larger studies would be indicated.…”

Section: Discussionmentioning

confidence: 99%

Sacral Nerve Neuromodulation for the Treatment of Lower Bowel Motility Disorders

Kenefick

2006

annals

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INTRODUCTION Incontinence and constipation are common and cause a high degree of physical, social and psychological impairment. Maximal conservative therapy may improve some patients but many remain symptomatic. Surgical options are often unsatisfactory, with variable result and further options are limited. Sacral nerve stimulation uses electrical stimulation applied to the sacral nerves, eliciting a physiological effect on the lower bowel, anal sphincter and pelvic floor, resulting in clinical benefit. The objective of this study was to investigate whether sacral nerve neuromodulation can improve patients with disorders of bowel motility, when current maximal treatment has failed and to investigate the underlying physiological mechanism of action. RESULTSIncontinence: Nineteen patients, age 58 years (range, 37-71 years), with resistant incontinence for 6 years (range, 2-21 years) underwent stimulation. Continence improved in all at 24 months (range, 3-60 months), fourteen fully continent. Incontinent episodes decreased; 12 (range, 2-30) versus 0 (range, 0-4), P < 0.001. Urgency ( P < 0.01) and quality of life improved ( P < 0.05). Anal squeeze pressure ( P = 0.001) and rectal sensation ( P < 0.01) improved.Constipation: Four women, (aged 27-36 years) with resistant idiopathic constipation for 8-32 years underwent the first worldwide implants. Symptoms improved in all with temporary, and in three with permanent, stimulation at 8 months (range, 1-11 months). Bowel frequency increased: 1-5 versus 6-28 evacuations/3-weeks. Symptom scores and quality of life improved.Placebo effect: A double-blind, cross-over study was performed to examine placebo effect and efficacy. Once stimulation was removed, in a blinded manner, symptoms, physiological parameters and quality of life measures rapidly returned to baseline levels.Autonomic neuromodulation: Sixteen patients, median age 59 years (range, 38-71 years), were studied at 27 months (range, 2-62 years) using laser Doppler flowmetry. Chronic stimulation was at 2.8 V (range, 0.3-3.9 V). Median flux differed between none and chronic stimulation (P = 0.001).Step-wise increments caused an immediate, dose-dependent rise in flux ( P < 0.0001) up to 1.0 V. CONCLUSIONS This research provides strong evidence that sacral nerve stimulation can improve patients with resistant incontinence and shows proof-of-concept for the treatment of constipation. The effect is unlikely to be due to placebo and the mechanism is rapidly reversible and involves a dose-dependent effect on the autonomic nerves.

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Section: Discussionmentioning

confidence: 99%

Sacral Nerve Neuromodulation for the Treatment of Lower Bowel Motility Disorders

Kenefick

2006

annals

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“…[17] Yet symptom improvement can also be seen in patients who didn't have a sensory response upon implantation which suggests that the amplitude can be set at a level below the sensory threshold without affecting the outcome. [18][19][20] This reflects the suggestion that the median amplitude necessary to provoke a sensory response is lower in patients with greatest reduction of symptoms. [21] 3.5 Thinking outside the box Building on the general principal of neuromodulation through sacral nerve stimulation and supported by cases similar to ours, other techniques have been developed where peripheral nerves are stimulated who connect anatomically to sacral nerves.…”

Section: Amplitudementioning

confidence: 52%

“…Several retrospective trials and 3 prospective crossover trials have proven the beneficial effect of this technique in the treatment of faecal incontinence with an overall success rate of 65%-80% among these patients. [1][2][3] The main advantage of this new technique is the possibility of reliably testing its effectiveness before carrying out the definitive procedure. [4] In this article, a case is described of a 74-year-old patient who had a sacral lead implanted in 2002 in another hospital.…”

Section: Introductionmentioning

confidence: 99%

Successful sacral nerve modulation despite migration of tined lead

Dekkers

Schmitz

Heyden

et al. 2016

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Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipation or incontinence when conservative treatment is insufficient to provide relieve of symptoms. Case description: A 74-year-old patient with an implanted sacral nerve lead is presented in this case report with a dislodged lead without an adverse change in her incontinence treatment. This phenomenon has never been described before and raises the debate on sacral lead positioning in sacral nerve stimulation. Discussion: There are a lot of conflicting data regarding ideal lead positioning, such as S3 versus S2 or S4 implantation. The lead position in our case doesn't correspond to previously described locations and pathways which corroborate the legitimacy of new developments in this area such as percutaneous tibial nerve stimulation, transcutaneous tibial nerve stimulation and transcutaneous abdominal electrical stimulation (TEN). Conclusions: The implantation of SNM seems standardized but leaves voids in the technique where further research is needed to refine it.

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“…The first sacral neuromodulation application was performed by Feler et al (6) in 1981, with indications of urinary incontinence, urinary frequency, and non-obstructive urinary retention. In addition, similar studies have been conducted for fecal incontinence (7,8). As a result of the abovementioned studies, for patients with insufficient responses to other treatments, FDA approval in the USA was obtained for the management of urinary incontinence in 1997, the approval for the treatment of polyuria and urinary retention not caused by an obstruction was obtained in 2006, and the approval for fecal incontinence was obtained in 2011.…”

Section: Historymentioning

confidence: 97%

A Different Option for Neuromodulation Procedures: Sacral Nerve Stimulation

Ozyalcin¹

2015

Turk J Phys Med Rehab

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The aim of this article is to determine the effectiveness and the safety of sacral nerve stimulation on the several indications. Sacral nerve stimulation as a neuromodulation technique, is an effective and increasingly used therapeutic option. As a minimally invasive technique, many advances in the techniques for sacral neuromodulation have been described. The well-known indication of sacral nerve stimulation is the urinary voiding dysfunction. Although the mechanism of neuromodulation is still unclear, multipl new indications have been identified, include faecal incontinence, constipation, pain sydromes, interstitial cystitis, mixt urinary and bowel disoders, spinal injury and neurodegenerative disease, and sexual dysfunction. Since there is lack of high quality evidence of the procedure at present, good quality prospective, cross-over and randomize controlled studies are required to determine the true benefits of sacral nerve stimulation.

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Double-blind crossover study of sacral nerve stimulation for fecal incontinence

Abstract: There is a marked, unequivocal improvement in symptoms of fecal incontinence with sacral nerve stimulation shown in this double-blind crossover trial. Sacral nerve stimulation improves the quality of life in selected patients with fecal incontinence.

Cited by 141 publications

References 13 publications

Sacral Nerve Neuromodulation for the Treatment of Lower Bowel Motility Disorders

Sacral Nerve Neuromodulation for the Treatment of Lower Bowel Motility Disorders

Successful sacral nerve modulation despite migration of tined lead

A Different Option for Neuromodulation Procedures: Sacral Nerve Stimulation

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