Sacral Nerve Stimulation for Fecal Incontinence

Wexner, Steven D.; Coller, John A.; Devroede, Ghislain; Hull, Tracy L.; McCallum, Richard W.; Chan, Miranda K. Y.; Ayscue, Jennifer M.; Shobeiri, Abbas; Margolin, David A.; England, Michael; Kaufman, Howard S.; Snape, William J.; Mutlu, Ece; Chua, Heidi K; Pettit, Paul; Nagle, Deborah; Madoff, Robert D.; Lerew, Darin R.; Mellgren, Anders

doi:10.1097/sla.0b013e3181cf8ed0

Cited by 316 publications

(62 citation statements)

References 67 publications

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“…In the sham arm there was a median of 6.9 FIEs per week, but with a slightly higher rate of passive FI (median 3.0 episodes) than urge episodes (median 2.5 episodes) ( Table 4). Hysterectomy, a n (%) 30 (29) 24 (24) Vaginal operation, a n (%) 3 (3) 2 (2) Pelvic operation, a n (%) 19 (18) 16 (16) Abdominal operation, n (%) 28 (24) 30 (27) Anal operation, n (%) 6 (5) 9 (8) Neck or back pain, n (%) 15 (13) 21 (19) OAB, n (%) 15 (13) 7 (6) Diverticular disease, n (%) 4 (3) 6 (5) Irritable bowel syndrome, n (%) 1 (1) 4 (4) a Females only (% calculated from females only). …”

Section: Bowel Diary Data At Baselinementioning

confidence: 99%

“…[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%

“…Although subject to criticism, this was chosen as the primary outcome for the study not least because it has most often been used to assess SNS, thus allowing comparisons to be drawn between the two treatment modalities. Further, the 50% criterion has been applied as the primary end point in both of the pivotal trials of contemporary treatments in FI, 27,81 with these treatments subsequently reviewed favourably by the US Food and Drug Administration. It could be argued that a 50% reduction in FIEs is not life-changing because this may still signify significant FI; however, until another outcome measure is introduced into the literature this is the most widely accepted outcome for treatment comparison.…”

Section: Limitationsmentioning

confidence: 99%

“…Of note, approximately 40% of participants appeared to have concomitant symptoms of FI and evacuatory difficulties (39% in PTNS arm and 44% in sham arm), and approximately 60% had concomitant urinary symptoms (61% in PTNS arm and 64% in sham arm). Fibre supplementation, n (%) 18 (16) 30 (27) Laxatives/suppositories/irrigation, n (%) 20 (17) 16 (14) Anal sphincter repair, n (%) 4 (3) 4 (4) Other anal surgery, n (%) 11 (10) 8 (7) Defecatory advice, n (%) 9 (8) 7 (6) Other, n (%) 5 (4) 8 (7) Obstetric history, a n (%) 95 (91) 96 (95) Vaginal deliveries only, a n (%) 90 (95) 96 (100) C-sections only, a n (%) 5 (5) 0 (0) Episiotomies or tears, a n (%) 78 (87) 82 (85) Passive FI, n (%) 88 (77) 86 (77) Urge FI, n (%) 94 (82) 93 (83) Flatus incontinence, n (%) 74 (64) 83 (74) Evacuatory difficulties, n (%) 44 (39) 49 (44) Straining, n (%) 34 (30) 37 (33) Digitation, n (%) 12 (10) 15 (13) Urinary symptoms, n (%) 70 (61) 72 (64) Urinary urgency, n (%) 50 (43) 49 (44) Urinary urge incontinence, n (%) 39 (34) 42 (38) C-section, caesarean section; IQR, interquartile range. a Females only (% calculated from females only).…”

Section: Baseline Findingsmentioning

confidence: 99%

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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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Section: Bowel Diary Data At Baselinementioning

confidence: 99%

Section: Management Of Faecal Incontinencementioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

Section: Baseline Findingsmentioning

confidence: 99%

See 2 more Smart Citations

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

View full text Add to dashboard Cite

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“…However, the complication rate among the 665 patients who had permanent SNS electrode implantation was ∼15%, resulting in permanent removal of the device in 18 (2.7%) patients 67. A multicenter, prospective nonrandomized trial, not included as part of the previous meta-analysis, reported that 83% of 106 patients had ≥50% improvement in FI at 12 months and 40% became fully continent 62. Improvements were sustained for 3 years 61,62.…”

Section: Resultsmentioning

confidence: 99%

Current and Emerging Treatment Options for Fecal Incontinence

Rao

2014

Journal of Clinical Gastroenterology

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Fecal incontinence (FI) is a multifactorial disorder that imposes considerable social and economic burdens. The aim of this article is to provide an overview of current and emerging treatment options for FI. A MEDLINE search was conducted for English-language articles related to FI prevalence, etiology, diagnosis, and treatment published from January 1, 1990 through June 1, 2013. The search was extended to unpublished trials on ClinicalTrials.gov and relevant publications cited in included articles. Conservative approaches, including dietary modifications, medications, muscle-strengthening exercises, and biofeedback, have been shown to provide short-term benefits. Transcutaneous electrical stimulation was considered ineffective in a randomized clinical trial. Unlike initial studies, sacral nerve stimulation has shown reasonable short-term effectiveness and some complications. Dynamic graciloplasty and artificial sphincter and bowel devices lack randomized controlled trials and have shown inconsistent results and high rates of explantation. Of injectable bulking agents, dextranomer microspheres in non-animal stabilized hyaluronic acid (NASHA Dx) has shown significant improvement in incontinence scores and frequency of incontinence episodes, with generally mild adverse effects. For the treatment of FI, conservative measures and biofeedback therapy are modestly effective. When conservative therapies are ineffective, invasive procedures, including sacral nerve stimulation, may be considered, but they are associated with complications and lack randomized, controlled trials. Bulking agents may be an appropriate alternative therapy to consider before more aggressive therapies in patients who fail conservative therapies.

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Sacral nerve stimulation for faecal incontinence and constipation in adults

Thaha

Abukar

Thin

et al. 2015

Cochrane Database of Systematic Reviews

136

103

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The limited evidence from the included trials suggests that SNS can improve continence in a proportion of patients with faecal incontinence. However, SNS did not improve symptoms in patients with constipation. In addition, adverse events occurred in some patients where these were reported. Rigorous high quality randomised trials are needed to allow the effects of SNS for these conditions to be assessed with more certainty.

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Sacral Nerve Stimulation for Fecal Incontinence

Abstract: Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

Cited by 316 publications

References 67 publications

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)

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)

Current and Emerging Treatment Options for Fecal Incontinence

Sacral nerve stimulation for faecal incontinence and constipation in adults

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