Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence

Duelund-Jakobsen, Jakob; Dudding, T. C.; Bradshaw, Elissa; Buntzen, Steen; Lundby, Lilli; Laurberg, Søren; Vaizey, C. J.

doi:10.1002/bjs.8867

Cited by 30 publications

(63 citation statements)

References 34 publications

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“…In contrast, changing frequency and pulse width has not been routine. Although two studies have demonstrated that changes in stimulation frequency (to higher frequency) and reductions in pulse width can have a short‐term positive impact on SNM outcome, to the present authors' knowledge no study has systematically explored a range of frequencies to determine whether an optimum exists.…”

Section: Introductionmentioning

confidence: 98%

Effects of stimulation frequency and intensity in sacral neuromodulation on anorectal inputs to the somatosensory cortex in an experimental model

Evers

Devane

Carrington

et al. 2014

British Journal of Surgery

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The effect of SNM in this animal model is governed principally by frequency, with an optimum of 2 Hz. If animal data can be translated to humans, optimization of SNM frequency may offer a clinically relevant improvement in the efficacy of SNM. Surgical relevance Sacral neuromodulation (SNM) for faecal incontinence currently employs stimulation parameters that have been derived empirically and may not be optimal. This study used an animal model of SNM and focused on its acute effect on anal canal cortical evoked potentials (EPs). It was found that SNM potentiated EPs, with a clear optimum at a frequency of 2 Hz. If this finding is applicable to the mechanism of action of human SNM, this suggests that there may be a clinically relevant improvement by reducing stimulus frequency from its typical value of 14 Hz to 2 Hz.

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Section: Introductionmentioning

confidence: 98%

Effects of stimulation frequency and intensity in sacral neuromodulation on anorectal inputs to the somatosensory cortex in an experimental model

Evers

Devane

Carrington

et al. 2014

British Journal of Surgery

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“…35 the CCfis modestly improved (-2.4 to -2.7 points) during the 4-week RCt segments with high frequency or prolonged pulse width stimulation, but no other outcomes were significantly or meaningfully improved.…”

Section: Methodsmentioning

confidence: 73%

“…to assign a grade of low strength of evidence rather than insufficient, we required at least 2 moderate risk of bias studies or 1 sufficiently powered, low risk-of-bias RCt for a specific Sacral Nerve Stimulation five crossover RCts examined sns, mostly in 55-to 60-year-old women with mixed fi etiologies (table 1). the evidence for sns was insufficient because all 5 of the studies had moderate 27,36 or high 28,29,35 risk of bias, and none assessed the same treatment-outcome combination. Brief RCt summaries are below; details are provided in table 1 and appendix table 3. the RCts compared the sns versus supportive medical care on fi outcomes <1 year.…”

Section: Methodsmentioning

confidence: 99%

“…the same scoring system was often referenced by several names. the Vaizey score (0-24 107 ) was sometimes labeled as "st. mark's" (0-13 108 ), 27,28,35 and the CCfis 109 was labeled as CCfis, Wexner, or Jorge/Wexner. more information about typical patient demographics, clinical features, and status at enrollment would better inform about which treatments work best in which patients.…”

Section: Limitationsmentioning

confidence: 99%

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Systematic Review of Surgical Treatments for Fecal Incontinence

Forte

Andrade

Lowry

et al. 2016

Diseases of the Colon &Amp; Rectum

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Evidence was insufficient to support clinical or policy decisions for any surgical treatments for fecal incontinence in adults. More invasive surgical procedures had substantial complications. The lack of compliance with study reporting standards is a modifiable impediment in the field. Future studies should focus on longer-term outcomes and attempt to identify subgroups of adults who might benefit from specific procedures.

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“…Although innumerable measures, scales and composite indices have been used, there is no acceptable gold standard or outcome measure. A selected list of recent RCTs spanning medical, biofeedback, injectable and surgical interventions are summarized in Table . This highlights the disparities in subject selection, trial design, outcome measures and risk of bias.…”

Section: Defining and Validating A Fi Endpointmentioning

confidence: 99%

Endpoints for therapeutic interventions in faecal incontinence: small step or game changer

Rao

2016

Neurogastroenterology Motil

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Fecal incontinence (FI) is common and its pathophysiology and treatments continue to evolve. However, a standard measure(s) for assessing its clinical outcome has been elusive. Consequently, over 100 measures and scoring systems, each with intrinsic biases have been reported. These include adequate relief or global satisfaction, ≥ 50% reduction in episodes or days without FI, quality of life (QOL), FI severity scales and composite indices. Earlier scales relied on the frequency and type of solid, liquid or flatus incontinence and effects on life style whereas newer scales have incorporated urgency, use of pads, antidiarrheals and amount of leakage, using prospective daily stool diaries or retrospective weekly or single point assessments. Such a plethora of measures have negatively impacted the assessment and outcome of clinical trials, and have made comparisons difficult. So, how does one sort out the grain from the chaff? In a provocative, post-hoc analysis published in this issue, the minimal clinically important difference, i e the smallest change detected by an instrument that is associated with a clinically meaningful change was used to assess FI endpoint Based on this a ≥ 50% reduction in FI episodes is recommended as a clinically meaningful outcome measure when assessed by stool diary, and it correlate with symptoms and severity. However, this requires further validation in multi-center, longer duration and therapeutically effective clinical trial(s). Simultaneous assessment of coping strategies, QOL and psychosocial domains can provide further insights regarding the overall impact of treatments . This mini-review discusses the advances and controversies in defining meaningful FI endpoints.

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Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence

Abstract: Patients experiencing loss of efficacy can experience improvement if alternative pacemaker settings are tested. High-frequency stimulation (31 Hz/210 µs) was preferred by more than half of the patients, and improved treatment outcome was sustained at 3 months.

Cited by 30 publications

References 34 publications

Effects of stimulation frequency and intensity in sacral neuromodulation on anorectal inputs to the somatosensory cortex in an experimental model

Effects of stimulation frequency and intensity in sacral neuromodulation on anorectal inputs to the somatosensory cortex in an experimental model

Systematic Review of Surgical Treatments for Fecal Incontinence

Endpoints for therapeutic interventions in faecal incontinence: small step or game changer

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