Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence

Thin, Noel N.; Horrocks, Emma J; Hotouras, Alexander; Palit, Shreela; Thaha, Mohamed A.; Chan, Christopher L.; Matzel, Klaus E.; Knowles, Charles H.

doi:10.1002/bjs.9226

Cited by 184 publications

(136 citation statements)

References 110 publications

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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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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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“…Our first experience and short-term results do not conflict with the literature data. According to the systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence, published by Thin et al, the initial success rate of sacral neuromodulation was found to be 63 %, with a long-term success rate of 54 % [2]. According to literature, sacral neuromodulation shows good long-term results for patients with idiopathic faecal incontinence [19,20].…”

Section: Discussionmentioning

confidence: 99%

“…In his recent study, Schwandner showed that sacral neuromodulation greatly improved symptoms in nine patients with low anterior resection syndrome after rectal resection and radiotherapy for rectal cancer [21]. Despite the fact that a loss in effectiveness of approximately 10 per cent is demonstrated within 5 years, sacral neuromodulation still remains an effective long-term treatment option [2]. However, the high price of SNM remains an obstacle to apply this treatment method widely.…”

Section: Discussionmentioning

confidence: 99%

“…However, this disabling condition is often under-reported because of fear and embarrassment. Most FI is caused by an interaction of various pathophysiological factors, including abnormal anorectal sensation, colorectal motility as well as anatomical changes to the pelvic floor and sphincter complex [1][2]. Nevertheless, it mainly affects females as a result of direct damage to the anal sphincter(s) or indirect damage caused by stretching of the pudendal nerve during childbirth [3].…”

Section: Introductionmentioning

confidence: 99%

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Sacral Neuromodulation for the Treatment of Faecal Incontinence: First Steps in Lithuania

et al. 2015

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SummaryTwo female patients with faecal incontinence resistant to conservative treatment but improved after percutaneous tibial nerve neuromodulation were treated with sacral nerve neuromodulation in 2014. Quality of Life questionnaires were used in order to determine the impact of faecal incontinence on everyday life before and after the implantation of the stimulator. To evaluate the functional state, Wexner's questionnaires were applied. Bowel movement diary was used to detect the improvement of faecal continence before and after temporary and permanent neuromodulation. The data were analyzed using a Statistical Package for Social Sciences program (SPSS, version 22.0). All values were given as mean ± SD. P-values less than 0.05 were accepted to indicate statistical significance. Both patients had a reduction in episodes of incontinence and soiling during a 3 week temporary nerve stimulation period as well as during 3 week followup after permanent stimulator implantation. Statistically significant elevation of faecal urgency frequency (p=0.031) was observed during temporary nerve stimulation. Reduction of episodes of faecal incontinence (p=0.001) and soiling (p=0.000) was observed after permanent stimulator implantation. Both patients presented an improvement in lifestyle, coping, depression and embarrassment as well as an improvement in functional state 3 weeks after the beginning of sacral nerve stimulation. Conclusions: The first results of sacral neuromodulation in patients with faecal incontinence are excellent and very promising.

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“…Sacral nerve modulation and transcutaneous posterior tibial neuromodulation have increasingly been used for fecal incontinence. However, the cure rates vary depending on the outcome measure in use with long‐term results reaching up to 54% for sacral neuromodulation 3, 4. Surgical methods often carry a risk of complications and are both demanding and expensive.…”

Section: Introductionmentioning

confidence: 99%

Functional Outcome of Human Adipose Stem Cell Injections in Rat Anal Sphincter Acute Injury Model

Kuismanen

Juntunen

Narra

et al. 2018

Stem Cells Translational Medicine

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Anal incontinence is a devastating condition that significantly reduces the quality of life. Our aim was to evaluate the effect of human adipose stem cell (hASC) injections in a rat model for anal sphincter injury, which is the main cause of anal incontinence in humans. Furthermore, we tested if the efficacy of hASCs could be improved by combining them with polyacrylamide hydrogel carrier, Bulkamid. Human ASCs derived from a female donor were culture expanded in DMEM/F12 supplemented with human platelet lysate. Female virgin Sprague‐Dawley rats were randomized into four groups (n = 14–15/group): hASCs in saline or Bulkamid (3 × 105/60 μl) and saline or Bulkamid without cells. Anorectal manometry (ARM) was performed before anal sphincter injury, at two (n = 58) and at four weeks after (n = 33). Additionally, the anal sphincter tissue was examined by micro‐computed tomography (μCT) and the histological parameters were compared between the groups. The median resting and peak pressure during spontaneous contraction measured by ARM were significantly higher in hASC treatment groups compared with the control groups without hASCs. There was no statistical difference in functional results between the hASC‐carrier groups (saline vs. Bulkamid). No difference was detected in the sphincter muscle continuation between the groups in the histology and μCT analysis. More inflammation was discovered in the group receiving saline with hASC. The hASC injection therapy with both saline and Bulkamid is a promising nonsurgical treatment for acute anal sphincter injury. Traditional histology combined with the 3D μCT image data lends greater confidence in assessing muscle healing and continuity. Stem Cells Translational Medicine 2018;7:295–304

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Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence

Cited by 184 publications

References 110 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)

Sacral Neuromodulation for the Treatment of Faecal Incontinence: First Steps in Lithuania

Functional Outcome of Human Adipose Stem Cell Injections in Rat Anal Sphincter Acute Injury Model

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