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Meta-Analysis
. 2024 Oct 29;10(10):CD002115.
doi: 10.1002/14651858.CD002115.pub6.

Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases

Claire L Todd  1 , Eugenie E Johnson  2   3 , Fiona Stewart  4 , Sheila A Wallace  5 , Andrew Bryant  2 , Sue Woodward  1 , Christine Norton  1
Affiliations
Meta-Analysis

Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases

Claire L Todd et al. Cochrane Database Syst Rev. .

Abstract

Background: People with central neurological disease or injury have a much higher risk of both faecal incontinence (FI) and constipation than the general population. There is often a fine line between the two symptoms, with management intended to ameliorate one risking precipitating the other. Bowel problems are observed to be the cause of much anxiety and may reduce quality of life in these people. Current bowel management is largely empirical, with a limited research base. The review is relevant to individuals with any disease directly and chronically affecting the central nervous system (post-traumatic, degenerative, ischaemic or neoplastic), such as multiple sclerosis, spinal cord injury, cerebrovascular disease, Parkinson's disease and Alzheimer's disease. This is an update of a Cochrane Review first published in 2001 and subsequently updated in 2003, 2006 and 2014.

Objectives: To assess the effects of conservative, physical and surgical interventions for managing FI and constipation in people with a neurological disease or injury affecting the central nervous system.

Search methods: We searched the Cochrane Incontinence Specialised Register (searched 27 March 2023), which includes searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings; and all reference lists of relevant articles.

Selection criteria: We included randomised, quasi-randomised (where allocation is not strictly random), cross-over and cluster-randomised trials evaluating any type of conservative, physical or surgical intervention against placebo, usual care or no intervention for the management of FI and constipation in people with central neurological disease or injury.

Data collection and analysis: At least two review authors independently assessed the risk of bias in eligible trials using Cochrane's 'Risk of bias' tool and independently extracted data from the included trials using a range of prespecified outcome measures. We produced summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE.

Main results: We included 25 studies with 1598 participants. The studies were generally at high risk of bias due to lack of blinding of participants and personnel to the intervention. Half of the included studies were also at high risk of bias in terms of selective reporting. Outcomes were often reported heterogeneously across studies, making it difficult to pool data. We did not find enough evidence to be able to analyse the effects of interventions on individual central neurological diseases. Additionally, very few studies reported on the primary outcomes of self-reported improvement in FI or constipation, or Neurogenic Bowel Dysfunction Score. Conservative interventions compared with usual care, no active treatment or placebo Thirteen studies assessed this comparison. The interventions included assessment-based nursing, holistic nursing, probiotics, psyllium, faecal microbiota transplantation, and a stepwise protocol of increasingly invasive evacuation methods. Conservative interventions may result in a large improvement in faecal incontinence (standardised mean difference (SMD) -1.85, 95% confidence interval (CI) -3.47 to -0.23; 3 studies; n = 410; low-certainty evidence). We interpreted SMD ≥ 0.80 as a large effect. It was not possible to pool all data from studies that assessed improvement in constipation, but the evidence suggested that conservative interventions may improve constipation symptoms (data not pooled; 8 studies; n = 612; low-certainty evidence). Conservative interventions may lead to a reduction in mean time taken on bowel care (data not pooled; 5 studies; n = 526; low-certainty evidence). The evidence is uncertain about the effects of conservative interventions on condition-specific quality of life and adverse events. Neurogenic Bowel Dysfunction Score was not reported. Physical therapy compared with usual care, no active treatment or placebo Twelve studies assessed this comparison. The interventions included massage therapy, standing, osteopathic manipulative treatment, electrical stimulation, transanal irrigation, and conventional physical therapy with visceral mobilisation. Physical therapies may make little to no difference to self-reported faecal continence assessed using the St Mark's Faecal Incontinence Score, where the minimally important difference is five, or the Cleveland Constipation Score (MD -2.60, 95% CI -4.91 to -0.29; 3 studies; n = 155; low-certainty evidence). Physical therapies may result in a moderate improvement in constipation symptoms (SMD -0.62, 95% CI -1.10 to -0.14; 9 studies; n = 431; low-certainty evidence). We interpreted SMD ≥ 0.5 as a moderate effect. However, physical therapies may make little to no difference in Neurogenic Bowel Dysfunction Score as the minimally important difference for this tool is 3 (MD -1.94, 95% CI -3.36 to -0.51; 7 studies; n = 358; low-certainty evidence). We are very uncertain about the effects of physical therapies on the time spent on bowel care, condition-specific quality of life and adverse effects (all very low-certainty evidence). Surgical interventions compared with usual care, no active treatment or placebo No studies were found for surgical interventions that met the inclusion criteria for this review.

Authors' conclusions: There remains little research on this common and, for patients, very significant issue of bowel management. The available evidence is almost uniformly of low methodological quality. The clinical significance of some of the research findings presented here is difficult to interpret, not least because each intervention has only been addressed in individual trials, against control rather than compared against each other, and the interventions are very different from each other. Understanding whether there is a clinically-meaningful difference from the results of available trials is largely hampered by the lack of uniform outcome measures. This is due to an absence of core outcome sets, and development of these needs to be a research priority to allow studies to be compared directly. Some studies used validated constipation, incontinence or condition-specific measures; however, others used unvalidated analogue scales to report effectiveness. Some studies did not use any patient-reported outcomes and focused on physiological outcome measures, which is of relatively limited significance in terms of clinical implementation. There was evidence in favour of some conservative interventions, but these findings need to be confirmed by larger, well-designed controlled trials, which should include evaluation of the acceptability of the intervention to patients and the effect on their quality of life.

Trial registration: ClinicalTrials.gov NCT02459717 NCT04451096 NCT03166007 NCT03031977 NCT04367571 NCT03377322.

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Conflict of interest statement

CT: None declared

EEJ: was Assistant Managing Editor for Cochrane Incontinence until 31 March 2023 and is an Editor for Cochrane. She was not involved in any part of the editorial process for this review.

FS: None declared

AB: None declared

ShW: None declared

SW: None declared

CN: was not involved in the selection, data extraction or risk of bias assessment of any studies for which she was an author (Coggrave 2010, McClurg 2018, Harari 2004). Single lecture fees from Medscape and Janssen Biotech were received in the past 3 years.

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References

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De Both 1992 {published data only}
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De Luca 2020 {published data only}
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Fang 2003 {published data only}
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Freeman 2016 {published data only}
    1. ISRCTN69614598. SUMS: standing up in people with multiple sclerosis [A multi-centre randomised controlled trial to assess the effectiveness and cost effectiveness of a home-based self-management standing frame programme plus usual care versus usual care in people with progressive multiple sclerosis (MS) who have severely impaired balance and mobility]. isrctn.com/ISRCTN69614598 (first received 03 February 2016).
Frisbie 1997 {published data only}
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Gourcerol 2012 {published data only}
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    1. NCT03949660. Improving bowel function and quality of life after spinal cord injury [Targeting improvements in bowel function and quality of life using epidural stimulation and training after severe spinal cord injury]. clinicaltrials.gov/show/NCT03949660 (first recieved 14 May 2019).
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    1. JPRN-UMIN000023159. The effect of lubiprostone for MMC patients. center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026531 (first received 13 July 2016).
Khan 2013 {published data only}
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Korsten 2004 {published data only}
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Krassioukov 2021 {published data only}
    1. NCT04726059. Motor and autonomic concomitant health improvements with neuromodulation and exoskeleton training: a RCT in individuals with SCI (MACHINE) [Motor and autonomic concomitant health improvements with neuromodulation and exoskeleton (MACHINE) training: a randomized controlled trial in individuals with SCI]. clinicaltrials.gov/show/NCT04726059 (first received 27 Januay 2021).
Krogh 2002 {published data only}
    1. Krogh K, Jensen MB, Gandrup P, Laurberg S, Nilsson J, Kerstens R, et al. Efficacy and tolerability of prucalopride in patients with constipation due to spinal cord injury. Scandinavian Journal of Gastroenterology 2002;37(4):431-6. - PubMed
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Li 2021 {published data only}
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Liu 2021 {published data only}
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Loening‐Baucke 1988 {published data only}
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Markwell 2006 {published data only}
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Marshall 1997 {published data only}
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McKee 2014 {published data only}
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Munchiando 1993 {published data only}
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Ondo 2012 {published data only}
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Parkinson's Study Group 2017 {published data only}
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Preechakawin 2022 {published data only}
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Rajendran 1992 {published data only}
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Rao 2005 {published data only}
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Rao 2010 {published data only}
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Stiens 1995 {published data only}
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References to studies awaiting assessment

Aghebati 2018 {published data only}
    1. IRCT20180721040547N1. The effect of massage therapy and life style education on gastrointestinal complications of stroke patients. en.irct.ir/trial/32736 (first received 02 November 2018).
George 2021 {published data only}
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IRCT2014111119911N1 {published data only}
    1. IRCT2014111119911N1. Effect of probiotic supplementation on constipation and bloating stroke patients [Effect of probiotic supplementation on some digestive problems, stroke patients]. en.irct.ir/trial/17685 (first received 06 January 2015).
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NCT04150549 {published data only}
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NCT04871464 {published data only}
    1. NCT04871464. Role and mechanism of probiotics in improving motor symptoms in mild to moderate Parkinson's disease. clinicaltrials.gov/ct2/show/NCT04871464 (first received 29 April 2021).
Pingping 2019 {published data only}
    1. Pingping J. Analysis of the effect of comprehensive nursing intervention based on Wexner scoring system on constipation symptoms and quality of life in patients with ischemic stroke and constipation [基于Wexner评分系统的综合护理干预对缺血性脑卒中合并便秘患者便秘症状及生活质量的影响分析贾苹苹. 基于Wexner评分系统的综合护理干预对缺血性脑卒中合并便秘患者便秘症状及生活质量的影响分析. 世界华人消化杂志 ]. World Chinese Journal of Digestology 2019;27(22):1402‐6.
Varanese 2016 {published data only}
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Yin 2020 {published data only}
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    1. Yue Y. A Randomized Controlled Trial to Investigate Percutaneous Tibial Nerve Stimulation for the Treatment of Constipation after Spinal Cord Injury [thesis]. Nanjing (China): Nanjing University of Chinese Medicine, 2015.

References to ongoing studies

ACTRN12617000727347 {published data only}
    1. ACTRN12617000727347. Comparing the use of a containment product for the treatment of faecal incontinence (IFI) in stroke survivors versus standard faecal incontinence (FI) care in a rehabilitation setting [A containment strategy using anal plugs for the treatment of intractable faecal incontinence (IFI) in stroke survivors versus standard FI care in a rehabilitation setting: a feasibility study]. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372846 (first received 2 May 2017).
ACTRN12620000991910p {published data only}
    1. ACTRN12620000991910p. Double-blind, placebo-controlled, cross-over trial of Livaux™ for the treatment of constipation and microbiome restoration in Parkinson’s disease. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379862 (first received 19 May 2020).
ChiCTR1800016795 {published data only}
    1. ChiCTR1800016795. The effect of probiotics Lactobacillus casei strain Shirota (LcS) on gastrointestinal symptoms of Parkinson's disease. chictr.org.cn/showprojen.aspx?proj=28085 (first received 25 June 2018).
ChiCTR2000036143 {published data only}
    1. ChiCTR2000036143. Study on the role of fecal microbiota transplantation in the pathogenesis and therapeutic intervention of patients with Parkinson's disease complicated with constipation. www.chictr.org.cn/showproj.aspx?proj=58508 (first received 21 August 2020).
ChiCTR2100049676 {published data only}
    1. ChiCTR2100049676. Effect of gastrointestinal rehabilitation on constipation after cerebral. www.chictr.org.cn/showprojen.aspx?proj=131586 (first received 8 August 2021).
Chitra 2019 {published data only}
    1. CTRI/2019/10/021815. Effect of stimulation for constipation in acute stroke [Effect of high voltage pulsed galvanic stimulation for constipation in acute stroke. A randomized clinical trial ]. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=36782 (first received 02 November 2019).
IRCT20110912007529N23 {published data only}
    1. IRCT20110912007529N23. The effect of massage therapy on gastrointestinal complications of stroke patients. http://en.irct.ir/trial/62921 (first received 20 April 2022).
IRCT20170608034390N11 {published data only}
    1. IRCT20170608034390N11. Effects of probiotics on constipation and symptoms of Parkinson Disease. http://en.irct.ir/trial/62963 (first received 14 May 2022).
Machado 2018 {published data only}
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NCT01920243 {published data only}
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NCT03987126 {published data only}
    1. NCT03987126. Prebiotics for spinal cord injury patients with bowel and bladder dysfunction [Use of novel human milk prebiotics to improve the quality of life for spinal cord injury patients with bowel and bladder dysfunction]. clinicaltrials.gov/show/nct03987126 (first received 14 June 2019).
NCT04127617 {published data only}
    1. NCT04127617. Effects of osteopathic manipulative treatment in people with neurogenic bowel dysfunction [Neurogenic bowel dysfunction: evaluation of the effects of osteopathic manipulative treatment in people with central nervous system injury]. clinicaltrials.gov/show/NCT04127617 (first received 15 October 2019).
NCT04307303 {published data only}
    1. NCT04307303. Electrical stimulation of abdominal muscles for bowel management in people with spinal cord injury [A randomised sham-controlled, proof of principle study of abdominal functional electrical stimulation (ABFES) for bowel management in spinal cord injury (SCI)]. clinicaltrials.gov/show/NCT04307303 (first received 13 March 2020).
NCT04707976 {published data only}
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NCT04829760 {published data only}
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NCT05146921 {published data only}
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NCT05176327 {published data only}
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References to other published versions of this review

Coggrave 2003
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