Is Sacral Neuromodulation Here to Stay? Clinical Outcomes of a New Treatment for Fecal Incontinence

Johnson, Bobby L.; Abodeely, Adam; Ferguson, Martha A.; Davis, Bradley R.; Rafferty, Janice F.; Paquette, Ian M.

doi:10.1007/s11605-014-2611-4

Cited by 24 publications

(10 citation statements)

References 29 publications

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“…This is in agreement with the significant improvement seen in the CCIS in published literature after commencement of SNM therapy [19,23,[33][34][35].…”

Section: Discussionsupporting

confidence: 92%

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study

Meurette¹,

Siproudhis

Leroi

et al. 2021

Colorectal Disease

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Aim:The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStim TM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable.Method: This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events.Results: A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001).Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. Conclusion:This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.

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“…This is in agreement with the significant improvement seen in the CCIS in published literature after commencement of SNM therapy [19,23,[33][34][35].…”

Section: Discussionsupporting

confidence: 92%

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study

Meurette¹,

Siproudhis

Leroi

et al. 2021

Colorectal Disease

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“…There is a large and growing body of evidence that a defect of the internal or external sphincter is not a contraindication for SNM for FI . Though clinical success has been reported in patients with sphincter defects up to 180 degrees, most would agree that the size of the defect does not matter and should not affect decision making .…”

Section: Fecal Incontinence (Fi)mentioning

confidence: 99%

“…There is a large and growing body of evidence that a defect of the internal or external sphincter is not a contraindication for SNM for FI. 50,[52][53][54][55][56][57][58][59][60][61] Though clinical success has been reported in patients with sphincter defects up to 180 degrees, 13,57,62 most would agree that the size of the defect does not matter and should not affect decision making. 50,54 This is likely because the proposed mechanism of action relies more on sensory nerve fibers and bowel motility than on muscular contraction.…”

Section: Fecal Incontinence (Fi)mentioning

confidence: 99%

International Continence Society best practice statement for use of sacral neuromodulation

Goldman

Lloyd

Noblett

et al. 2018

Neurourology and Urodynamics

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138

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“…Tjandra et al studied patients with external sphincter defects up to 120° and demonstrated 100 % continence in 41.5 % and 75 – 99 % improvement over baseline [11]. The neurophysiologic basis underlying this correlation is likely the proposed sensory neuromodulatory effects of SNM rather than a direct effect on the external anal sphincter [9]. …”

Section: Discussionmentioning

confidence: 99%

Does preoperative anal physiology testing or ultrasonography predict clinical outcome with sacral neuromodulation for fecal incontinence?

et al. 2015

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Introduction and hypothesis To determine the value of preoperative anal physiology testing and transanal ultrasonography in predicting clinical response to sacral neuromodulation for fecal incontinence. Methods We report a retrospective study of all patients treated with sacral neuromodulation for fecal incontinence in a single practice between 2011 and 2014 was performed. Patient demographics included age, gender, comorbidities, presence of an ultrasound-defined external sphincter defect, and history of prior anal sphincter repair. Cleveland Clinic Florida (CCF) scores were used to assess the severity of fecal incontinence at baseline, and at 3, 6 and 12 months. Pearson's correlation coefficient was used to evaluate the relationship between preoperative physiology testing and ultrasonography and patient outcome. Results Sacral neuromodulation was trialed in 60 patients, of whom 31 had anorectal physiology testing and 29 did not. Patients who were tested were younger (60.9 vs. 71.4 years, p=0.013) and more likely to have had a prior overlapping sphincteroplasty (40.5 % vs. 15 %, p=0.043). Among patients who progressed to complete system implantation, CCF scores at 3 and 12 months were similar whether they had physiology testing or not. Likewise, patient outcome did not correlate with the finding of an ultrasound-defined external sphincter defect. Pearson's correlation coefficient was used to evaluate the relationship between the test results and the 3-month CCF scores. CCF scores 3 months after full system implantation did not correlate with the presence or size of an external sphincter defect, resting or squeeze pressure, pudendal nerve terminal motor latency, rectoanal inhibitory reflex, or minimum detectable volume. Conclusions Anal physiology testing and ultrasonography were not predictive of clinical outcomes among patients treated with sacral neuromodulation for fecal incontinence.

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Is Sacral Neuromodulation Here to Stay? Clinical Outcomes of a New Treatment for Fecal Incontinence

Abstract: SNM is a safe and effective therapy for the treatment of FI. Postoperative patient surveillance is important, as many patients require programming changes, and some will require a lead revision over time.

Cited by 24 publications

References 29 publications

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study

International Continence Society best practice statement for use of sacral neuromodulation

Does preoperative anal physiology testing or ultrasonography predict clinical outcome with sacral neuromodulation for fecal incontinence?

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