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. 2015 Aug 24;2015(8):CD004464.
doi: 10.1002/14651858.CD004464.pub3.

Sacral nerve stimulation for faecal incontinence and constipation in adults

Mohamed A Thaha #  1 , Amin A Abukar #, Noel N Thin, Anthony Ramsanahie, Charles H Knowles
Affiliations

Sacral nerve stimulation for faecal incontinence and constipation in adults

Mohamed A Thaha et al. Cochrane Database Syst Rev. .

Abstract

Background: Faecal incontinence (FI) and constipation are both socially-embarrassing and physically-disabling conditions that impair quality of life. For both, surgery may be required in a minority of people when more conservative measures fail. However, the invasiveness and irreversible nature of direct surgery on bowel and sphincter muscles, poor long-term outcomes and well-established compIications makes such procedures unappealing for these benign conditions. A less-invasive surgical option to treat faecal incontinence and constipation is direct, low-voltage stimulation of the sacral nerve roots, termed sacral nerve stimulation (SNS). SNS has become the first line surgical treatment for FI in people failing conservative therapies. Its value in the treatment of constipation is less clear.

Objectives: To assess the effects of sacral nerve stimulation using implanted electrodes for the treatment of faecal incontinence and constipation in adults.

Search methods: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, ClinicalTrials.gov, the World Health Organization (WHO) ICTRP and handsearched journals and conference proceedings (searched 5 February 2015), EMBASE (1 January 1947 to 2015 Week 5), and the reference lists of retrieved relevant articles.

Selection criteria: All randomised or quasi-randomised trials assessing the effects of SNS for faecal incontinence or constipation in adults.

Data collection and analysis: Two review authors independently screened the search results, assessed the methodological quality of the included trials, and undertook data extraction.

Main results: Six crossover trials and two parallel group trials were included.Six trials assessed the effects of SNS for FI. In the parallel group trial conducted by Tjandra, 53 participants with severe FI in the SNS group experienced fewer episodes of faecal incontinence compared to the control group who received optimal medical therapy (mean difference (MD) -5.20, 95% confidence interval (CI) -9.15 to -1.25 at 3 months; MD -6.30, 95% CI -10.34 to -2.26 at 12 months). Adverse events were reported in a proportion of participants: pain at implant site (6%), seroma (2%) and excessive tingling in the vaginal region (9%).In the parallel group trial carried out by Thin, 15 participants with FI in the SNS group experienced fewer episodes of FI compared with the percutaneous tibial nerve stimulation (PTNS) group (MD -3.00, 95% CI -6.61 to 0.61 at 3 months; MD -3.20, 95% CI -7.14 to 0.74 at 12 months). Adverse events were reported in three participants: mild ipsilateral leg pain during temporary testing (n = 1); and stimulator-site pain following insertion of neurostimulator (n = 2).In the crossover trial by Leroi 7 of 34 recruited participants were excluded from the crossover due mainly to complications or immediate device failure. Twenty-four of the remaining 27 participants while still blinded chose the period of stimulation they had preferred. Outcomes were reported separately for 19 participants who preferred the 'on' and five who preferred the 'off' period. For the group of 19, the median (range) episodes of faecal incontinence per week fell from 1.7 (0 to 9) during the 'off' period to 0.7 (0 to 5) during the 'on' period; for the group of five, however, the median (range) rose from 1.7 (0 to 11) during the 'off' period compared with 3.7 (0 to 11) during the 'on' period. Four of 27 participants experienced an adverse event resulting in removal of the stimulator.In the crossover trial by Sørensen and colleagues, participants did not experience any FI episodes in either the one-week 'on' or 'off' periods.In the crossover trial by Vaizey, participants reported an average of six, and one, episodes of faecal incontinence per week during the 'off' and 'on' periods respectively in two participants with FI. Neither study reported adverse events.In the crossover trial by Kahlke, 14 participants with FI experienced significantly lower episodes of FI per week during the stimulator 'on' (1 (SD, 1.7)) compared with the 'off' period (8.4 (SD, 8.7)). Adverse events reported include: haematoma formation (n = 3); misplacement of tined lead (1); and pain at stimulator site (n = 1).Two trials assessed SNS for constipation. In the Kenefick trial, the two participants experienced an average of two bowel movements per week during the 'off' crossover period, compared with five during the 'on' period. Abdominal pain and bloating occurred 79% of the time during the 'off' period compared with 33% during the 'on' period. No adverse events occurred. In contrast, in the trial by Dinning with 59 participants, SNS did not improve frequency of bowel movements and 73 adverse events were reported, which included pain at site of the implanted pulse generator (32), wound infection (12), and urological (17) events.

Authors' conclusions: 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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Conflict of interest statement

Some members of the review author group (NNT, MAT, CHK) are authors of a recently‐published overview on the wider topic of neuromodulation including SNS (Thin 2013). The Royal London Hospital's team under Professor Knowles heads many original clinical and methodological studies on neuromodulation, including SNS and PTNS.

Figures

1
1
PRISMA flow diagram
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 1 Episodes of faecal incontinence per week.
1.2
1.2. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 2 Days using pads per week.
1.3
1.3. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 3 Days with incontinence per week.
1.4
1.4. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 4 Days with faecal staining per week.
1.5
1.5. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 5 Cleveland Clinic Incontinence Score.
1.6
1.6. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 6 SF12 Physical.
1.7
1.7. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 7 SF12 Mental.
1.8
1.8. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 8 FIQL Lifestyle.
1.9
1.9. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 9 FIQL Coping/behaviour.
1.10
1.10. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 10 FIQL Depression/self perception.
1.11
1.11. Analysis
Comparison 1 Faecal incontinence: parallel group data SNS vs medical therapy, Outcome 11 FIQL Embarrassment.
2.1
2.1. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 1 Episodes of faecal incontinence per week.
2.2
2.2. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 2 Cleveland Clinic Incontinence Score.
2.3
2.3. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 3 FIQL Lifestyle.
2.4
2.4. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 4 FIQL Coping.
2.5
2.5. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 5 FIQL Depression.
2.6
2.6. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 6 FIQL Embarrassment.
2.7
2.7. Analysis
Comparison 2 Faecal Incontinence: parallel group data SNS vs PTNS, Outcome 7 EQ‐5D.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Dinning 2015# {unpublished data only}
    1. Dinning PG, Hunt L, Patton V, Tzang T, Szczesniak M, Gebski V, et al. Treatment efficacy of sacral nerve stimulation in slow transit constipation: A two phase, double blind randomized controlled crossover study. American Journal of Gastroenterology 2015;110(5):733‐40. [sr‐incont67952] - PubMed
Kahlke 2015# {published data only}
    1. Kahlke V, Topic H, Peleikis HG, Jongen J. Sacral nerve modulation for fecal incontinence: results of a prospective single‐center randomized crossover study. Diseases of the Colon & Rectum 2015;58:235‐40. [sr‐incont66462] - PubMed
Kenefick 2002# {published data only}
    1. Kenefick NJ. Sacral nerve neuromodulation for the treatment of lower bowel motility disorders. Annals of The Royal College of Surgeons of England 2006;88(7):617‐23. [22235] - PMC - PubMed
    1. Kenefick NJ, Vaizey CJ, Cohen CR, Nicholls RJ, Kamm MA. Double‐blind placebo‐controlled crossover study of sacral nerve stimulation for idiopathic constipation. British Journal of Surgery 2002;89(12):1570‐1. [sr‐incont16145] - PubMed
Leroi 2005# {published data only}
    1. Leroi AM, Parc Y, Lehur PA, Mion F, Barth X, Rullier E, et al. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double‐blind crossover study. Annals of Surgery 2005;242(5):662‐9. [sr‐incont21269] - PMC - PubMed
Sørensen 2010# {published data only}
    1. Sørensen M, Thomsen F. Sacral nerve stimulation increases rectal sensitivity in patients with faecal incontinence: results of a randomised double‐blinded crossover study (Abstract number 437). Proceedings of the Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association, 2010 Aug 23‐27, Toronto, Canada. 2010. [sr‐incont40174]
Thin 2015 {published data only}
    1. Thin NN, Taylor SJC, Bremner SA, Emmanuel AV, Hounsome N, Williams NS, et al. Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence. British Journal of Surgery 2015;102(4):349‐58. [sr‐incont66403] - PubMed
Tjandra 2008 {published data only}
    1. Tjandra J, Lim J, Green C, Carey M. Sacral neuromodulation in patients with faecal incontinence: a randomized controlled study on efficacy and quality of life (Abstract number 090). Colorectal Disease 2005;7(Suppl 1):31. [sr‐incont24001]
    1. Tjandra JJ, Chan MKY, Yeh CH, Murray‐Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: A randomized, controlled study. Diseases of the Colon and Rectum 2008;51(5):494‐502. [sr‐incont27640] - PubMed
Vaizey 2000# {published data only}
    1. Vaizey CJ, Kamm MA, Roy AJ, Nicholls RJ. Double‐blind crossover study of sacral nerve stimulation for fecal incontinence. Diseases of the Colon & Rectum 2000;43(3):298‐302. [sr‐incont11184] - PubMed

References to studies excluded from this review

Dinning 2007 {published data only}
    1. Dinning PG, Fuentealba SE, Kennedy ML, Lubowski DZ, Cook IJ. Sacral nerve stimulation induces pan‐colonic propagating pressure waves and increases defecation frequency in patients with slow‐transit constipation. Colorectal Disease 2007;9(2):123‐32. [sr‐incont22557] - PubMed
Dinning 2013 {published data only}
    1. Dinning P, Patton V, Hunt L, Gebski V, Jones M, Stewart P, Lubowski D, Cook I. Efficacy of sacral nerve stimulation for severe slow transit constipation: A randomised, double‐blind, placebo‐controlled, crossover study. Diseases of the Colon and Rectum 2013;56(4):e116. [sr‐incont49771]
Knowles 2012 {published data only}
    1. Knowles CH, Thin N, Gill K, Bhan C, Grimmer K, Lunniss PJ, et al. Prospective randomized double‐blind study of temporary sacral nerve stimulation in patients with rectal evacuatory dysfunction and rectal hyposensitivity. Annals of Surgery 2012;255(4):643‐9. [sr‐incont45223] - PubMed

References to ongoing studies

Borjesson 2013 {published data only}
    1. Borjesson L. Sacral nerve stimulation vs anal bulking for faecal incontinence ‐ a randomised controlled trial. http://isrctn.org/ISRCTN00247992 2013. [sr‐incont64540]
Jayne 2014 {published data only}
    1. Jayne D. Safari: Sacral nerve stimulation versus the FENIX TM magnetic sphincter augmentation for adult faecal incontinence: a prospective, UK multi‐site, parallel‐group, randomised clinical study investigating the safety and efficacy of the FENIX TM magnetic sphincter augmentation (MSA) compared to sacral nerve stimulation (SNS) for adult FI. http://isrctn.org/ISRCTN16077538 2014. [sr‐incont64510]
Vallance 2014 {published data only}
    1. Vallance A, Brown S, Nugent K, Lodge J, Protheroe D, Neville K, et al. Study design: Sacral nerve stimulation versus the FENIXTM magnetic anal sphincter for adult faecal incontinence: A randomised investigation (SaFaRI) (Abstract number W191). Colorectal Disease 2014;16(Suppl s2):197. [sr‐incont66262]

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