Emerging Approaches for Bowel and Bladder Management following ...

Emerging Approaches for Bowel and Bladder Management following Spinal Cord Injury Briefing Document June 2014

Emerging Approaches to Bowel and Bladder Management following SCI – Briefing Document

The NTRI Forum: The NTRI Forum is a three-year project that aims to improve the care of brain, spinal cord or other major traumatic injuries. The NTRI Forum’s model involves defining the major challenges through consultation with key stakeholders to understand the issues and complexities; gathering and summarising from publications and further consultation the information necessary to properly consider each challenge; convening stakeholder dialogues to connect this information with the people who can make change happen; and briefing the organisations and individuals who can effect change about their role in developed strategies. For more information visit www.ntriforum.org.au Authors Dr Loretta Piccenna, PhD, BSc (Hons), Research Fellow, National Trauma Research Institute, The Alfred and Monash University; Melbourne, Australia. Natasha Dodge, MPH, BSc (Hons), Research Fellow, National Trauma Research Institute, The Alfred and Monash University; Melbourne, Australia. Dr Peter Bragge, PhD, B Physio (Hons), Senior Research Fellow, National Trauma Research Institute, The Alfred and Monash University; Melbourne, Australia. Professor Russell Gruen, MBBS, PhD, FRACS, Professor of Surgery and Public Health, The Alfred and Monash University; Director, National Trauma Research Institute; Melbourne, Australia. Funding: This briefing document and the stakeholder dialogue were funded by the Victorian Transport Accident Commission (TAC) as part of a project entitled ‘Harnessing Victoria’s Neurotrauma Expertise: promoting excellence and realising value.’ Russell Gruen is supported by a National Health and Medical Research Council Practitioner Fellowship. Conflict of interest: Peter Bragge is a co-applicant and Russell Gruen is a collaborating researcher and the National Trauma Research Institute is a collaborating institution on the program ‘Developing a Community of Practice for Knowledge Translation and Practice Improvement in Spinal Cord Injury and Traumatic Brain Injury.’ The funder played no role in the identification, selection, assessment, synthesis, or presentation of the research evidence profiled in the briefing document. Acknowledgements: We gratefully acknowledge the support of Associate Professor Doug Brown (Director, Spinal Research Institute) in providing expert knowledge and feedback. We also thank Associate Professor Virginia Lewis and the independent reviewers of the briefing document for their feedback. We would like to thank Ms Joan Hume for providing a patient perspective on bladder dysfunction following SCI. Citation: Piccenna L, Dodge, N, Bragge, P, Gruen RL. Briefing document: Emerging approaches for Bowel and Bladder Management following Spinal Cord Injury. Melbourne, Australia: NTRI Forum, June 2014. ISBN 978-0-9923793-6-0 Copyright © Monash University 2013. All rights reserved. Except as provided in the Copyright Act 1968, this work may not be used, reproduced, adapted or communicated without the written consent of the copyright owner who can be contacted via email: [email protected]. Disclaimer: 1


The information in this work is provided for education, research and information purposes only and should not be relied on or taken as medical or any other form of professional advice. Individuals seeking specific advice or assistance should contact a qualified medical practitioner or other professional as appropriate. This work contains information which was current at the time it was published but Monash University does not represent or warrant its accuracy, suitability or completeness. This information may contain links to websites which are outside the control of Monash University. These links are provided for your convenience only. Monash University do not endorse the accuracy or suitability of such websites or their content. You use the information in this work at your own discretion and risk. To the extent permitted by law, Monash University excludes all liability for any loss or damage whatsoever suffered as result of or in relation to the use of this information, including the information in the linked websites, by you.

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Table of Contents Executive Summary .................................................................................................... 4 Background ................................................................................................................ 5 Aims and Terms of Reference .................................................................................. 10 Overview of the evidence for bowel and bladder management following SCI .......... 12 Emerging research approaches for bowel and bladder management ...................... 23 Issues to consider for bowel and bladder management ........................................... 28 References ............................................................................................................... 29 Appendices ............................................................................................................... 32

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Executive Summary Bowel and bladder dysfunction (BBD) has a significant impact on the quality of life of people with spinal cord injury (PwSCI). The prevalence of BBD in PwSCI is not well known. Whilst not all people with an SCI will be affected, those affected may experience either a loss of bowel control, severe constipation, urinary incontinence, infection or possibly a combination of these conditions. BBD has not only physical consequences but also psychological consequences that impact on the person’s social life, their independence and their ability to maintain employment. Even for PwSCI who do not experience incontinence, the fear of it potentially occurring can cause anxiety, social embarrassment or isolation, contributing to a poorer quality of life. Several interventions exist for the management of BBD in PwSCI; however, these interventions have not changed significantly over the last 20 years with much of the evidence that guides current practice based on trials with only a small number of patients. More recently, new areas of promise have emerged in the management of BBD in SCI, such as the use of assistive devices, irrigation techniques and pharmacological treatments such as botulinum toxin A (Botox). Whilst more research is still needed, uptake of promising and emerging therapies into practice needs to be considered to ensure that those who need the treatment most will be the ones to benefit. How research can be progressed from the “benchto-bedside” requires innovative thinking from experts in the area of spinal cord research and treatment. This NTRI Forum aims: 1. To develop a shared understanding of the impact of bowel and bladder issues for those with SCI. More specifically, a. Bowel and bladder problems have a significant impact on quality of life; and b. Management has not changed significantly in the last 20 years. 2. To assess and inform emerging, innovative research approaches in the management of BBD for PwSCI living in the community (dissemination); 3. To identify the challenges and barriers of ‘bench-to-bedside’ research in this area; 4. To develop a collaborative approach with other researchers and funding bodies in associated areas to advance the field (collaboration).

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Background Introduction Every year in Australia, approximately 350-400 new cases of traumatic spinal cord injury (SCI) occur, further contributing to the 12 000 individuals currently living with a SCI.1 Due to the physical and functional disruptions in the central nervous system, people with SCI (PwSCI) are at an increased risk of bowel and bladder dysfunction. Depending on the level and severity of the injury, the type of bowel and bladder dysfunction can vary. Current bowel and bladder management strategies although somewhat effective, have not changed significantly over the last 20 years. Hence, new and effective strategies are needed to reduce the burden associated with bowel and bladder dysfunction in PwSCI. Spinal cord injury and the impact on bowel function The function of the healthy lower bowel (rectum and anal sphincter) in people in the general population is to act by storing and emptying waste products in a coordinated manner under voluntary control. Movement of waste products is coordinated by the intrinsic nervous system of the bowel and modulated by the central nervous system. In PwSCI, there is a lack of central nervous control to feed signals to the bowel, resulting in colonic dysfunction, also known as neurogenic bowel. Symptoms associated with neurogenic bowel include dysmotility, increased colonic transit time, constipation and reduced sphincter control. Two distinct types of bowel dysfunction that can occur are upper motor neuron (UMN) and lower motor neuron (LMN).2 UMN dysfunction (or suprasacral, reflex or spastic type) results when injury occurs above the thoracic T10 vertebra or T12 spinal segment and is characterized by increased colonic wall and anal tones. There is a loss of voluntary (cortical) control as the external anal sphincter remains tight promoting retention of the stools. The sacral reflex defecation centre remains intact allowing stool propulsion. Symptoms that typically occur include constipation, fecal retention, and incontinence.2 LMN dysfunction (infrasacral, arelexic or flaccid type) results when injury occurs below the thoracic T10 vertebra or T12 spinal segment. It is characterized by the loss of centrally mediated peristalsis and slow stool propulsion. The lack of control and tone over the external anal sphincter means that lower motor neuron type dysfunction is often associated with incontinence.2 Spinal cord injury and the impact on bladder function The normal functioning bladder is able to store urine at a low pressure and empty effectively with voluntary control. The smooth muscle of the bladder (known as the detrusor) is in a relaxed state whilst waste products are filtered from the blood by the kidneys to form urine. As the bladder fills, the detrusor stretches, signalling the urge to urinate at certain voiding volumes. At an appropriate time, volitional sphincter muscle relaxation, detrusor contraction, and bladder emptying is achieved in a coordinated manner at low pressure.3 This process of storage and voiding relies on coordination of the peripheral autonomic, peripheral somatic, and central nervous systems.

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Depending on the level of injury in PwSCI, this coordinated process can be disrupted, resulting in bladder dysfunction, also known as neurogenic bladder dysfunction. The two main types of neurogenic bladder dysfunction reported in PwSCI are neurogenic detrusor overactivity and detrusor areflexia.4 Detrusor Overactivity associated with Sphincter Dyssynergia (Detrusor-external sphincter dyssynergia - DESD) Detrusor Overactivity associated with Sphincter Dyssynergia is seen in PwSCI whose injury has affected the upper motor neurons. There is a lack of coordination between the sphincter and the detrusor, and overactivity of both muscles due to a lack of control and descending inhibition from two regions of the brain - the pons and cortex, resulting in high blood pressure.4 This in turn leads to incontinence at high pressures, incomplete emptying (due to sphincter co-contraction), and reflux with resultant bladder infections, stones, hydronephrosis, pyelonephritis and renal failure.4 Detrusor Arelexia This type of dysfunction is most commonly seen when the sacral reflex is disrupted. There is a loss of tone of the detrusor muscle preventing the bladder from emptying completely. This can often lead to bladder wall damage from overfilling, urine reflux and an increase in infection risk due to stasis. Increased abdominal pressure on the bladder and reduced external sphincter control commonly results in incontinence.4 In other cases the external urethral sphincter lacks tone and urine continuously leaks from the bladder. This continuous incontinence leads to malodorous urine and skin infections, which are very distressing for PwSCI. Quality of life in people with SCI Current interventions and management of bowel and bladder dysfunction in PwSCI living in the community, although somewhat satisfactory, are not ideal. The negative impact that bowel and bladder dysfunction has on quality of life (QoL) is still being identified by PwSCI as a high priority.5, 6 A recent quantitative systematic review investigated health and life functions rated as most important by PwSCI.5 Bowel and bladder control was rated as one of the highest health functions. More specially, regardless of the type of injury (tetraplegia and paraplegia), PwSCI identified bowel and bladder function as the second highest priority. However, one of the included studies in the review looked specifically at PwSCI with paraplegia and in this study bowel and bladder function was identified as the highest priority. Evidence in Australasia in support of these findings has revealed that overall bowel and bladder function is the highest priority rated by PwSCI (34%) – this is followed by walking (19%), and arm and hand function (18%).7 PwSCI with paraplegia rated bowel and bladder as the most important function to improve their life (39%) over walking (22%), whereas those with tetraplegia rated bowel and bladder function and arm and hand function as equally important (both 30%). Bowel Three studies not included in the systematic review were also identified for bowel dysfunction in PwSCI.8-10 One study reported that PwSCI and bowel dysfunction had lower levels of satisfaction with family life, friendships, free time and life than those with normal function.8 Similarly, in another study PwSCI reported reduced life satisfaction due to incontinence, greater number of interventions used and long duration of bowel care.10 The authors also 6


found that bowel dysfunction was rated as having the greatest impact on their life in comparison to other complications of SCI. In the context of the importance of bowel and bladder control, a recent study reported that just over half of the PwSCI surveyed were satisfied with their current bowel management (54%, n=127).9 Although no statistically significant difference was observed between those satisfied and those dissatisfied with their management programs, there was a significant difference shown in QoL. There was a poorer QoL for PwSCI dissatisfied with their bowel management which was associated with difficulties such as pain, poor results from ineffective interventions and the duration required to carry out the intervention/management program.9 Those who were satisfied with their bowel management had a higher QoL reporting better social functioning (i.e. not cancelling social engagements or avoiding attending events without a close bathroom) and work functioning (quality of work slipping or unable to attend due to bowel problems).9 Bladder A recent systematic review confirmed that PwSCI with bladder dysfunction have a poor health-related quality of life (HRQoL).6 In comparison to people with urinary incontinence (UI) alone, or those with a neurological condition that do not have UI, those with a neurological condition (such as SCI) and UI had a significantly lower HRQoL. Four studies were identified for PwSCI and UI. All four studies reported low scores for physical and mental domains of HRQoL. One of the studies also highlighted the impact of UI on sexual function. PwSCI and UI reported being dissatisfied with their sexual function and this was particularly significant for men.6 One study that was not included in the review also showed that PwSCI with bowel and bladder dysfunction who are dependent (require assistance for bowel and bladder management) have a significantly lower QoL in aspects including mobility, physical independence, occupational function and creating new social relationships, in comparison to those who are independent.11 The consequences of bladder dysfunction that negatively impact on the quality of life of PwSCI include primarily physical factors such as urinary tract infections (UTIs) which may be recurrent, kidney damage, increased pain, body spasms or fever, and also psychological factors such as difficulty accepting assistance of their carer or family member with their management program, the amount of time involved daily in their care and fear of incontinence when out in the community or with friends and family. The aim of effective bowel and bladder management in PwSCI is to ensure that defecation and urination are regular and that they occur at predetermined socially appropriate times. In addition, it should occur in a way that minimises interruption to normal life as much as possible and reduces the incidence of complications. Management needs to consider both the physical and psychological issues of a PwSCI. To improve the quality of life of PwSCI it is important to align future research efforts to factors and priorities that PwSCI consider most meaningful in their lives – more innovative bowel and bladder management is needed.

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Box 1: The perspective and experience of a PwSCI living with a neurogenic bladder “A Tale from the soggy trenches - Living with a neurogenic bladder” by Joan Hume I was injured in a car accident in November 1971 at the age of 23. At the time I was working as a high school teacher in western Sydney and the car accident occurred in the course of my duties. My injury was of the C6/7 vertebrae, but below at the C8/T1 nerve level which only became clarified after several weeks and months. This was an era of no MRIs to aid diagnosis, conservative treatment, no psychological adjustment counselling, perfunctory patient education, minimal physiotherapy and exercise programmes and crude options for managing the female bladder. Admitted to Royal North Shore Hospital, Sydney, the first couple of weeks in intensive care were a blur of relentless lights, numbing pain and the moans and death cries of my fellow patients. I was barely aware of my bladder, only a vague and certainly ill-informed sense that I had an indwelling catheter. There were more important things to deal with, or so I thought. The psychological consequences of loss of bladder control are devastating at any age but the distress of trying to function socially in the hostile inaccessible world of the 1970s as a young woman was soul destroying. The only public wheelchair accessible toilet in the whole of Sydney was situated at the airport! The indwelling catheter was the option most preferred by women who could not transfer onto a toilet and/or had poor hand function. In one sense, it is the least intrusive and most convenient of options and over the years I have resorted to it especially when travelling, in hospital or when I’ve been very ill. But as more and more women and men age with a spinal cord injury its long term impact can be life-threatening. Apart from the ever present dangers of frequent urinary tract infections, kidney and bladder stones and bladder trauma from the presence of a foreign body, a blocked catheter can cause autonomic dysreflexia, stroke or heart attack. Long term bladder trauma can lead to bladder cancer and all that that implies. I had returned to teaching in a school which was not really accessible, except for a ground floor portable ramp and cheaply modified toilet which I shared with the school principal. Over those first five years I experimented with various medications to help tame the untameable: Valium, Lioresal and Monodral. None of them gave anything more than fleeting relief. My bladder severely affected my ability to socialise with friends, form intimate relationships, perform with optimum competence at work, travel or be far away from a toilet at any time. In 1976, a miserable wreck, I visited my urologist to seek a more viable solution to this problem. He introduced me to an experimental project he was conducting at Prince Henry Hospital mostly for women with MS. This involved self-catheterisation. I was the first woman with a spinal cord injury (so I was told) to use this method in Australia. Once I’d learned the technique of clean intermittent catheterisation utilising a specially made reusable glass catheter it revolutionised my life. To me it was miraculous and utterly liberating. Within a few years, self-catheterisation was the standard method of bladder management for men and women post spinal cord injury for those with good hand function. I became involved in disability activism, experimented with other jobs, secondments to policy and research positions in education, community services and finally left teaching to work in the NSW Department of Health as a senior policy advisor in disability. This would never have been possible without better bladder control and its resulting sense of confidence and the lifting of my spirits. In addition, thanks to the International Year of Disabled Persons in 1981, there were increasing numbers

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of public buildings, theatres, recreation venues, shopping centres, etc. which were providing better access including wheelchair accessible toilets. Moving around the community became less of an ordeal and more a pleasant outing. Alas, it was not to last. As the years wore on, the infections became more frequent. At one stage I succumbed to acute pyelonephritis with septicaemia and was gravely ill. I began to bleed more frequently and often confused the bleeding for infection. I realise now that the bleeding was less about infection and more about trauma to the bladder. The culprit was, I later discovered was my technique. While use of disposable catheters eventually became the preferred method, they were very expensive, costing well over $1 per catheter which over weeks and months costs hundreds of dollars, most of which is unsubsidised, unless one is on a pension. By the time I realised I needed to seriously modify my technique, it was too late. Tiny pre-cancerous growths had started to appear on the lining of my bladder wall. This was in 2006, six years after a diagnosis of chronic myeloid leukaemia (CML). To what extent, if any, the eventual development of a more severe form of bladder cancer was related to having CML is debatable. As one by one, the recurring tumours were burnt away, my bladder function and ability to retain urine declined. Eventually the size of my bladder shrank so much I was unable to retain any volume of urine at all. Unless I had an indwelling catheter I was saturated all the time. In early 2009, my urologist started me on a course of BCG vaccines (cancer treatment) in an attempt to inhibit the tumours. It was discontinued after four treatments because I kept haemorrhaging and a few weeks later I developed tuberculosis. Finally it was decided that my bladder had to be removed and a urostomy performed. Well I had now come full circle. The operation was carried out in mid2009 and I gradually learned how to manage the stoma and bag. It took some months before I felt confident in my technique. Now five years on, my life is much easier again. Had I had access to my removed bladder post-operatively, I would have had no hesitation in ritually burning it. Of all the profound losses of spinal cord injury, to me loss of bladder control and all its attendant humiliations is by far the worst.

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Aims and Terms of Reference Aims of the Forum This NTRI Forum aims: 1. To develop a shared understanding of the impact of bowel and bladder issues for those with spinal cord injury. More specifically, a. Bowel and bladder problems have a significant impact on quality of life; and b. Management has not changed significantly in the last 20 years. 2. To inform and assess emerging, innovative research approaches in the management of the bowel and bladder for people with SCI living in the community (dissemination); 3. To identify the challenges and barriers of ‘bench to bedside’ research in this area; 4. To develop a collaborative approach with researchers and stakeholders in associated areas to advance the field forward (collaboration).

Terms of Reference The Emerging Approaches in Bowel and Bladder Management following SCI Forum will address the following: 1. What is currently known in practice and research about bowel and bladder management following SCI? 2. What are the challenges or barriers being faced in translating new research from the bench to the bedside? 3. What strategies could be used to address the identified challenges and barriers? 4. What are the next steps in advancing the identified strategies forward and who should be involved? Context of this NTRI Forum NTRI Forum topics are identified through liaison with a broad range of Neurotrauma research networks and organisations. All potential NTRI Forum topics are submitted to the Victorian Neurotrauma Advisory Council (VNAC) for approval. VNAC is an expert body representing key stakeholders in the Victorian Neurotrauma community including the Transport Accident Commission (TAC) and government, health and community services, researchers, and patient advocacy groups. Further information about VNAC can be found at: http://www.ntri.org.au/research/vnac Publically available outputs from this NTRI Forum could be utilised by researchers and other stakeholders to inform or develop projects in related areas. This NTRI Forum topic was approved by VNAC in June 2013.

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Aims of the briefing document This briefing document is directed towards researchers, clinicians, service delivery and advocacy organisations and other stakeholders with experience and expertise in bowel and bladder management following SCI. The aims of the briefing document are to: 1. Present an overview of the current evidence for bowel and bladder management following SCI 2. Outline emerging research approaches for bowel and bladder management following SCI 3. Present questions for deliberation to inform future translation of optimal bench-tobedside approaches for bowel and bladder management following SCI. Box 2: Background and Scope This briefing document was prepared to inform a structured stakeholder dialogue at which research evidence is one of many considerations. The dialogue aims to connect the information from the briefing document with the people who can make change happen, and energise and inspire the participants by bringing them together to address a common challenge. This use of collective problem solving can create outcomes that are not otherwise possible, because it transforms each individual’s knowledge to a collective ‘team knowledge’ that can spark insights and generate action addressing the issue.

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Overview of the evidence for bowel and bladder management following SCI A search was conducted to identify clinical practice guidelines for bowel and bladder management following spinal cord injury (SCI) using the terms “spinal cord injury”, “bowel”, and “bladder”. A total of twelve full text articles were retrieved. Only three relevant SCIspecific guidelines – one for bladder12 and two for bowel13, 14, one non SCI-specific guideline for bladder management, 15 and three systematic reviews – three SCI-specific2, 4, 16 and one non SCI-specific17 - were identified. A gray literature search and resources from experts in the field resulted in four SCI-specific guidance documents based on expert opinion – two for bowel18, 19 and two for bladder management.3, 20 Recommendations from Clinical Practice Guidelines for bowel and bladder management following SCI Clinical Practice Guidelines (CPGs) are “systematically developed statements to assist practitioner and patients’ decisions about appropriate health care for specific clinical circumstances” (Field and Lohr 1990 p. 38).21 Three guidelines were identified containing recommendations for bowel13 and bladder management12, 14 following SCI: 





Consortium for Spinal Cord Medicine (1998). Neurogenic Bowel Management in Adults with Spinal Cord Injury. Washington DC,: 1-40. [This guideline contains 31 recommendations; 4 on assessment of impairment and function, 17 on management (including design of a program, nutrition, at home or in the community, and program effectiveness), 5 on managing complications, 3 on surgical and non-surgical therapies; and 2 on educational strategies.13] Consortium for Spinal Cord Medicine (2006). Bladder Management for Adults with Spinal Cord Injury: A Clinical Practice Guideline for Health-Care Providers. Washington, DC, Paralysed Veterans of America: 1-51. [This guideline contains 58 recommendations; 8 on intermittent catheterisation, 4 on crede and Valsalva (abdominal massage), 7 on indwelling catheterisation, 6 on reflex voiding, 5 on alphablockers, 5 on botulinum toxin injection, 4 on endourethral stents, 4 on transurethral sphincterotomy, 4 on electrical stimulation and posterior sacral rhizotomy, 5 on bladder augmentation, 1 on continent urinary diversion, 3 on urinary diversion, and 2 on cutaneous ileovesicostomy.12] Academy of Nutrition and Dietetics (AND) (2009). "Spinal Cord Injury Evidence-based nutrition guideline - What level of fibre is recommended to manage neurogenic bowel in spinal cord injury patients?" Retrieved 23 April, 2014, from http://andevidencelibrary.com/template.cfm?key=2282. [This guideline contains 5 recommendations specific to neurogenic bowel; 4 on nutrition intervention, and 1 on nutrition monitoring and evaluation.14] 12


Recommendations and information on supporting evidence from SCI-specific and non-SCI specific guidelines are contained in Appendix 1. A summary of the volume of these recommendations and evidence from SCIRE/SCI-specific evidence reviews is contained in Table 1 below. Table 1: Overview of the volume of recommendations/evidence developed from SCIspecific and non SCI-specific guidelines and SCIRE/SCI evidence reviews: Recommendation categories

SCIspecific guidelines 13, 14

Non SCIspecific guideline

SCIRE/SCI Evidence 2, 17 reviews

Non-SCI Evidence review

Total

BOWEL Assessment of the impairment and disability

3

n/a

3

Assessment of function (disability)

1

n/a

1

Designing a bowel program

6

4

10

Nutrition

7

1

8

Managing the bowel at home or in the community

4

2

6

Digital rectal stimulation

n/a

1

1

Electrical and magnetic stimulation

n/a

5

5

Irrigation

n/a

4

4

Pharmacological treatments

n/a

9

9

Abdominal massage

n/a

2

2

Monitoring program effectiveness

5

n/a

5

Managing complications

5

n/a

5

Surgical and Non-surgical therapies

3

5

8

Education strategies

2

0

2

Recommendation categories

Overall total

69

Non-SCI Evidence review

Total

SCIspecific 12 guideline

Non SCIspecific guideline

SCIRE/SCI Evidence 4 review

Assessment

0

6

n/a

6

Intermittent Catheterisation

8

1

7

16

Crede and Valsalva (Abdominal massage)

4

1

1

6

Indwelling catheterisation

7

1

6

14

Reflex voiding

6

1

0

7

Alpha-blockers

5

3

5

13

Anti-cholinergics

0

0

6

6

Other pharmacological treatments

0

0

5

5

15

BLADDER

13


Botulinum Toxin Injection/Vanilloid compounds

5

2

6

13

Urethral stents

4

1

2

7

Transurethral sphincterotomy

4

0

4

8

Electrical stimulation, posterior sacral rhizotomy and artificial sphincter

4

3

10

17

Bladder augmentation

5

1

2

8

Continent urinary diversion/urinary diversion

4

1

2

7

Cutaneous Ileovesicostomy

2

0

0

2

Other

0

0

3

3

Quality of Life

0

2

n/a

2 Overall total

194

*n/a – beyond scope of guideline/review Table 1 reflects the lack of up-to-date, high level evidence-based clinical practice guidance for bowel and bladder management for SCI. Not included in Table 1 was a recent publication that provided a ‘proposed’ clinical guideline for bladder management in PwSCI using expert consensus in the absence of evidence.20 The authors stated that it is important to have guidance from clinical practice to ensure that PwSCI are safe in light of low level evidence and not knowing when high quality evidence will become available. Hence, engaging PwSCI for bowel and bladder management research is a key challenge that needs to be considered for producing future evidence-based clinical guidance and optimal care. Overall, a significant number of recommendations/evidence exists for bladder management in comparison to bowel management (Table 1). This further reflects the greater amount of research that has been conducted in bladder management to date and the limited research in bowel management. Overview of evidence from the most up-to-date systematic reviews Bowel management following SCI The aim of effective bowel management is to provide regular and reliable bowel emptying, maintain continence, prevent constipation and impaction, avoid over distention of the colon and rectum, and prevent long term complications. Effective management is often best achieved with the establishment of a routine that allows effective evacuation of the bowel at a pre-specified and predictable time. A recent review examined the effects of management strategies for faecal incontinence and constipation in people with a neurological disease or injury affecting the central nervous system.17 The review included eight studies in patients with SCI measuring the effectiveness of bowel management therapies. Interventions assessed included physical interventions (Christensen 200622-24, Coggrave 201025, Cornell 197326, Korsten 200427), laxatives and rectal stimulants (House 199728 and Cornell 197326) and pharmaceutical interventions 14


(Korsten 200529, Krogh 200230, Rosman 200831). Effectiveness of interventions was assessed using a number of outcome measures, including, but not limited to constipation and faecal incontinence scores and total time for bowel care. The various interventions will be discussed in more detail below. Pharmaceutical interventions Two pharmaceutical interventions, neostigmine-glycopyyrolate and prucalopride were assessed for their effectiveness in bowel management.17 In one study, intramuscular injection of neostigmine-glycopyyrolate was shown to be effective in reducing total bowel care time.31 The use of prucalopride (a systemic enterokinetic drug, selective and specific 5HT4 agonist targeting serotonin-4 receptors involved in initiation peristalsis) was shown to increase the median number of bowel movements and reduce colonic transit time.30 However, no change was observed in other bowel care related parameters such as duration of bowel care, use of anal stimulation or digital evacuation, faecal incontinence or unproductive toilet visits was seen. Laxatives and Rectal stimulants In a comparison of two rectal suppositories, polyethylene glycol based bisacodyl suppository (PGB) and hydrogenated vegetable based bisacodyl suppository (HVB), PGB was found to have some benefits over HVB.28 These benefits included shorter mean time between insertion and first flatus, and a shorter defecation period and total time spent performing digital stimulations during bowel care. However, there were no significant differences in mean times of stool flow or number of digital stimulations per bowel care routine. In addition, the number of episodes of faecal incontinence and stool volume produced were not significantly different between the two suppositories28. One study found that in comparison to irritant-contact laxative medication and stimulant laxative medication, mechanical evacuation without oral stimulant laxatives is associated with the most effective bowel control in regards to the time required for evacuation.26 This study however was conducted on patients in a rehabilitation institute and therefore it is unclear how effective this management strategy would be for patients living independently in the community. Physical interventions In addition to the study by Cornell26 which compared laxatives and mechanical intervention, three additional studies were included in the review that assessed the effectiveness of physical interventions, including, abdominal wall massage27, manual evacuation25 and transanal irrigation22-24. Electrical stimulation using an abdominal belt with embedded electrodes was found to have benefits in reducing total bowel care time and reduced time to first stool.27 An analysis of the findings from Christensen,22-24 showed that transanal irrigation in addition to conservative bowel management, compared to conservative bowel management alone provided statistically significant benefits for constipation scores, incontinence, satisfaction scores and total time for bowel care.17 A small study assessed the effectiveness of a stepwise protocol of least (i.e. massage) to most invasive (i.e. manual 15


evacuation) interventions in comparison to usual care. For the stepwise protocol, the duration of bowel care was consistently longer, as was time to first stool and faecal incontinence was more frequent. In addition, the use of less invasive techniques did not reduce the need for more invasive interventions.32 Diet Although optimisation of dietary and fluid intake is listed in guidelines as a way of achieving effective bowel management there is limited evidence to support any dietary interventions. The advice of consuming a diet high in fruits and vegetables, and containing significant levels of whole grain foods is based on the dietary recommendations for the general population.18 Surgical options Surgical options for managing neurogenic bowel dysfunction include implantation of electrical stimulation systems, colostomy and Malone antegrade continence enema and the continence catheter (MACE). There is evidence to suggest that sacral nerve root stimulation yields improvement in bowel function.17 A colostomy or ileostomy is normally only undertaken when all other medical treatments available have been exhausted. There is evidence from a number studies as reported in the review by Krassioukov et al 2 that colostomy reduces the number of hours spent on bowel care. There is also evidence to suggest that it simplifies the bowel care routine and improves physical health, independence and thus quality of life. Complications associated with ineffective bowel management Developing an effective bowel management program requires assessment and evaluation of the needs of the individual. As interventions vary in cost, benefits and consequences, not all interventions will be appropriate for some individuals. A hierarchy of interventions which moves from conservative, simple, low cost interventions, such as, developing a routine, diet and fluid management and laxatives to more complicated, costly, invasive interventions, such as colostomy is suggested as a way to develop effective bowel management programs for individuals.19 It does state however, that not all levels will be appropriate for all individuals and that movement up or down the pathway should be guided by ongoing assessment and evaluation. One aim of developing an individual bowel management program is to prevent complications that may arise due to neurogenic bowel dysfunction. Complications associated with ineffective bowel management include:19         

Faecal incontinence, Constipation, Faecal Impaction, Megacolon/megarectum, Haemorrhoids, Rectal Prolapse, Anal fissure or tear, Autonomic dysreflexia, and Pressure ulcers and falls during bowel care. 16


A common complication of neurogenic bowel dysfunction is chronic constipation, in which pain may or may not be present. Where constipation is present, an urgent review and appropriate adjustment in the bowel management program should be performed as soon as possible. If constipation is not identified and remedied faecal impaction may occur, this can further result in ulcers and necrosis of tissue.33

Bladder management following SCI Bladder management is highly diverse, individualised, and gender dependent in PwSCI. There are multiple factors to be considered which have an impact on the type of program or management that a person will utilise in their daily living, i.e. the extent of injury and nerve damage to bladder function, level of injury (paraplegic vs. tetraplegic or dependent vs. independent) and use of motor function in the upper body to carry out bladder management, and the type of lifestyle. Information for management options are best sort from a team of health professionals including a spinal cord specialist, a neuropsychologist, urologist, primary care physician, nurses and occupational therapists. Many management options are utilised over the life of a person with SCI, however nonsurgical options are attempted initially followed by the more permanent and risky options. Current bladder management options include catheterisation, reflex voiding, botulinum toxin (Botox) injection, pharmaceutical agents (alpha blockers, anti-cholinergics) and surgical procedures (bladder augmentation, sphincterotomy, diversion, and electrical stimulation). Only the two most common bladder management options will be discussed below – catheterisation and pharmacological therapies for enhancing bladder volumes and emptying (for more information, see Wolfe, D et al4). Catheterisation There are a few types of catheterisation which exist for use with bladder dysfunction – intermittent catheterisation (IC), indwelling catheterisation and external or condom catheterisation. To choose the most appropriate method for a person with SCI, a urodynamic assessment is conducted which informs the clinician of any presence of reflux, bladder pressure and bladder storage. A recent systematic review4 accessing bladder management in SCI identified only one small study (n=12) that investigated the effectiveness of IC in PwSCI. IC is one of the most preferred conservative management methods by PwSCI due to the lowest risk of complications associated with it. There is high evidence (one RCT and one lower quality RCT) that use of pre-lubricated hydrophilic catheters for IC results in a lower incidence of urinary tract infections (UTIs) and bleeding in comparison to poly vinyl chloride catheters (one RCT).4 Low level evidence showed that uretheral complications and epididymoorchitis occur more frequently in PwSCI using IC, however there was an improved upper urinary tract in comparison to those using indwelling catheterisation. Low level evidence for portable ultrasound devices in reducing the frequency and cost of IC was also reported.4

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Although indwelling catheterisation may be a reasonable management method for PwSCI with poor hand function, spasticity or who are dependent, there is insufficient evidence for its long-term use. Low evidence shows that there is a greater risk of bladder cancer with the use of indwelling catheters, in particular in the second decade of use.4 Pharmacological treatments for bladder dysfunction Numerous pharmacological treatments are available to assist with bladder dysfunction, depending on the type of dysfunction present. To enhance the bladder volume in PwSCI with an overactive bladder, anti-cholinergic therapy and pharmacological treatments such as baclofen and clonidine are available. A recent SR has reported that although these therapies are widely available, trials in PwSCI are limited.4 Four types of anti-cholinergics that have been shown to be effective in PwSCI are propiverine, oxybutynin, tolterodine and trospium chloride. In current practice, oral oxybutynin is prescribed to PwSCI and overactive bladder, however there are several side effects of which dry mouth is the most common.3 To overcome the side effects of oral oxybutynin, transdermal delivery with skin patches can be utilised or even other anti-cholinergics such as tolterodine. High level evidence from two RCTs shows that another anti-cholinergic – propiverine - significantly improves bladder capacity and in one of the RCTs was equivalent in effectiveness to oxybutynin and with fewer side effects.3 Trospium chloride also has high evidence of effectiveness from a single RCT in PwSCI by not only increasing bladder capacity and compliance, but also decreasing bladder pressure and having relatively few side effects. Low level evidence with one prospective controlled trial using combinations of tolterodine/oxybutynin, trospium/tolterdine and oxybutynin were successful in PwSCI who had little success with only one anti-cholinergic on its own.4 However, due to the low level evidence, further studies are required. Unfortunately, the only available anti-cholinergic available to PwSCI that is covered by the Pharmaceutical Benefits Scheme (PBS) is oxybutynin.3 However, as high level evidence from small single open label prospective controlled trial has shown that tolterodine and oxybutynin are equally effective for overactive bladder, but there is less dry mouth as a side effect with tolterodine.4 The pharmaceutical agent onabotulinum toxin A can be used for PwSCI that have been resistant to high doses of anti-cholinergic therapies. A SR has reported that there is high level evidence from two RCTs in PwSCI that when used with intermittent self-catheterisation it is effective in reducing bladder overactivity and urge incontinence.4 High level evidence also exists for botulinum toxin A in improving the flow of urine from the bladder for emptying in a single RCT and several controlled (2 studies) and uncontrolled studies (4 studies). It has been shown to be safe and effective. The use of botulinum toxin A in PwSCI should only be considered when other pharmaceutical therapies are ineffective or not well tolerated.3 However, botulinum toxin A needs to be directly injected into the bladder muscle (with use of a cystoscope) and needs to be repeated after 6 months, hence is not a long-term solution.

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Other drugs including capsaicin, resiniferatoxin and nociception/orphanin phenylalanine glutamine (N/OFG) also have high level evidence for their effectiveness, however these drugs are not currently available for this use in PwSCI in Australia. Alpha-adrenergic blockers have also been used in PwSCI for improving bladder emptying. However, only one blocker has high level evidence to support its effectiveness, in particular by decreasing urethral closure pressure – moxisylyte.4 Other blockers including tamsulosin, terzosin, and phenoxybenzamine have low level evidence of their effectiveness and require further evidence, particularly in terms of their side effects. Complications arising from poor bladder management A successful bladder management program provides PwSCI the ability to regain control of their bodies, have more self-confidence and be able to integrate into the community. However, some complications can occur from poor bladder management, including –        

Frequent urinary tract infections (UTIs) Bladder stones Bladder cancer (in some cases) Strictures or False passage Kidney damage (stones, distension - hydronephrosis) Hematuria (blood in the urine) Vesico-ureteric reflux Autonomic dysreflexia

One of the most common complications associated with poor bladder management is urinary tract infections (UTIs). Symptoms that are associated with UTIs in general include increased incontinence, small volumes of urine on voiding, feeling unwell, high temperature/fever, increased spasm, and pain3. However, in PwSCI, due to their injury these symptoms may not be detected or may even be absent. Therefore, detection methods have been investigated in PwSCI to make diagnosis of UTIs more accurate. In particular, for PwSCI that have indwelling catheters it is recommended that the catheters be removed before collection of a urine sample to decrease false positive tests (limited high level evidence).4 It is still unknown (low level evidence) if the use of dipstick tests for presence of nitrites or leukocytes esterase as confirmation of bacteriuria (bacteria from the bladder only) is useful to assist diagnosis or treatment of UTIs.4 Treatment of UTIs UTIs in PwSCI with a dysfunctional bladder are more commonly known as “complicated UTIs” due to their functionally impaired bladder and resistance to antibiotics utilised by the general population that experience UTIs3. The most common antibiotics used for PwSCI are fluoroquinolones due to their wide spectrum. A systematic review has reported that high level evidence exists for the use of the fluoroquinolones - ciprofloxin for 14 days (one RCT) and ofloxacin for 3 or 7 days (one RCT) – in effectively treating UTIs in PwSCI, over the common trimethoprim-sulfamethoxazole (TMP-SMX).4 Another group of antibiotics – the 19


aminoglycosides – have been investigated in an RCT but have not shown effectiveness for the treatment of UTIs in PwSCI.4 The type of treatment is dependent on the particular UTI present and the person’s UTI history. Catheterisation and UTIs There is limited evidence for UTIs and intermittent catheterisation in the community (low level evidence). Only one case control study investigated the incidence of UTIs following intermittent catheterisation comparing PwSCI in the inpatient setting with those in the community setting, in which similar rates were reported.4 An RCT (high level evidence) has shown that UTIs are lower in incidence when pre-lubricated nonhydrophillic catheters are used in comparison to poly vinyl chloride ones. Also, another study has reported that there is a reduction in antibiotic treatment for symptomatic UTIs when hydrophilic catheters are used in comparison to non-hydrophilic catheters (high evidence).4 High level evidence from a prospective controlled trial has shown that the incidence of UTIs is lower when intermittent catheterisation is used in comparison to indwelling catheterisation.4 However, not all PwSCI can use intermittent catheterisation due to their injury or perhaps lack of effectiveness; hence prevention of UTIs is most important in these cases. Prevention of UTIs There are several approaches to the prevention of UTIs which are being adopted by PwSCI – bacterial inference, antibiotic prophylaxis, antiseptics, nutritional supplements and educational interventions. Bacterial inference is an approach in which bacteria that do not result in UTIs are deposited into the bladder to prevent UTIs from occurring.4 Evidence from an RCT and two uncontrolled studies using inoculation with E.coli 83972 in PwSCI has revealed that there are significantly less UTIs experienced in comparison to with no or unsuccessful bacterial inference.4 However, further evidence is needed in larger groups of PwSCI to conclude that E.coli 83972 inoculation prevents UTIs. Antibiotic prophylaxis with long-term use of ciprofloxacin and trimethoprim-sulfamethoxazole (TMP-SMX) in PwSCI has high level evidence in preventing UTIs.4 However, with TMP-SMX, long-term use is not yet recommended as one study in PwSCI in the community showed conflicting results, hence further studies are needed. Prophylaxis in PwSCI for preventing UTIs is still contentious. The use of antiseptics for prevention of UTIs in PwSCI is an approach that is motivated by establishing good hygiene practices to decrease contamination in persons and the environment around them. An RCT using the antiseptic - methenamine hippurate - taken orally (alone or with cranberry) has shown it is not effective in preventing UTIs in PwSCI.4 Bladder irrigation using antiseptics is another approach that has been investigated. Most antiseptics utilised (trisdine, kanamycin-colistin, neomycin/polymyxin, acetic acid, ascorbic acid and phosphate supplementation) have been ineffective in preventing UTIs, except for the antiseptic, hemacidrin, combined with the oral antiseptic, methenamine mandelate, however this has only been shown in one study in the inpatient setting.4 20


Nutritional supplementation with cranberry to prevent UTIs in PwSCI has conflicting evidence regarding its effectiveness.4 One RCT showed a significantly lower incidence of UTIs in PwSCI taking cranberry tablets for 6 months in comparison to those who were not. However, three other RCTs were not able to show any reduced incidence in UTIs following cranberry treatment. Hence, it cannot be determined if cranberry treatment assists in prevention of UTIs in PwSCI. A non-pharmacology approach to preventing UTIs in PwSCI is the provision of an educational intervention of maintaining proper bladder care. There is high level evidence (one RCT and a prospective controlled study) for SCI specialists conducting an educational program with written information provided and a single follow-up telephone call in PwSCI in reducing the incidence of UTIs.4 Other uncontrolled studies have similarly shown support but there is no evidence for whether one approach is better than another and requires further investigation.

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Current practice for bowel and bladder management following SCI There is very little that is known about the current practices that exist for bowel and bladder management in PwSCI. In Australia, several state-wide SCI services provide fact sheets3, 18, 34 which are based on the only three existing SCI-specific guidelines12-14 and two SCI-specific systematic reviews.4, 16 The most recent guideline for bowel management was published over 16 years ago and similarly for bladder management over 8 years ago, reflecting a gap in the alignment and use of the most current evidence-based research in current practice. Although, there has been greater research in bladder management in PwSCI, for bowel management this has not been the case and has not changed significantly over the “last two decades”.35 This has enormous implications on PwSCI who experience bowel dysfunction and cannot receive effective management to carry out activities of daily living and feel integrated into the community. Hence, there is a need for more innovative and emerging approaches to be supported and adopted in current practice in a timely manner to ensure optimal success in the management of bowel and bladder dysfunction and better care for PwSCI.

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Emerging research approaches for bowel and bladder management To facilitate more innovative and emerging approaches for people with SCI (PwSCI) with bowel and/or bladder dysfunction a search of current clinical trials (clinicaltrials.gov, anzctr.org.au, and spinalnetwork.org.au/research-and-clinical-trials/searchable-database) identified eight registered trials (Table 2). In the USA, one trial is utilising a Telehealth educational program for the evaluation of selfmanagement of bowel and bladder health, measuring quality of life as an outcome. 36 Four trials are investigating bowel dysfunction only in PwSCI - two trials in the USA, one in Australia and one in Denmark. One study involves a surgical somatosensory reflex arch being created;37 one study is observational and involves ingestion of a wireless pill capsule to monitor pH, temperature and pressure and transit time;38 another study involves administration of a pharmaceutical prokinetic intranasally;39 and the final one is a physiotherapy intervention using a tilt table to investigate if standing improves bowel function (New South Wales, Australia).40 Three studies are investigating bladder dysfunction only – two in the USA and one in Australia. Two of the studies involve surgical interventions – tissue bonding cystostomy,41 and lumbar to sacral ventral nerve re-routing.42 The last study involves probiotic prophylaxis for PwSCI with recurrent urinary tract infections due to multi-resistant organisms – ProSCIUTTU (New South Wales, Australia).43

A research program in Victoria titled ‘Autonomic dysfunction in spinal cord injury: A strategy for improved treatment and understanding of bowel, blood pressure and bladder disorders’ has been undertaken since 2009.44 The program is composed of three separate and distinct projects utilising funding from the Victorian Neurotrauma Initiative/Transport Accident Commission and the National Health and Medical Research Council. The first project is concerned with bowel management following SCI and is being led by Professor John Furness. This project aims to look at a novel pharmacological therapy which effectively allows emptying of the bowel and greater control in bowel function in PwSCI. It is hoped that ultimately this will give PwSCI more confidence in their quality of life such that they can perform daily activities without the fear of incontinence. This project is currently enrolling and recruiting PwSCI in a clinical trial using the novel pharmacological therapy. The second project addresses the control of blood pressure in PwSCI whom at night experience an increase in blood pressure that results in excess production of urine, incontinence, disrupted sleep and significant postural hypotension on rising. This project is led by three clinicians at Austin Health – Associate Professor Doug Brown, Professor Albert 23


Frauman and Associate Professor Christopher O’Callaghan. A treatment that controls blood pressure is currently being trialled in PwSCI to reduce the increased blood pressure which occurs on resting. The third project investigates the management of bladder dysfunction in PwSCI. More specifically, it aims to address a common complication from bladder dysfunction – recurrent urinary bladder infection (cystitis). The project is looking at identifying the factors which affect bladder integrity making it more susceptible to infection and further identify a novel treatment to restore the function of the bladder lining in PwSCI. This project is being led by Associate Professor James Brock at the Department of Anatomy and Cell Biology, University of Melbourne. This program of research will bring more innovative management approaches for bowel and bladder dysfunction in PwSCI and improve their quality of life to be able to feel more willing to participate in everyday activities and feel secure in being out in the community.

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Table 2: Overview of Current Emerging Therapies for Bowel and Bladder Health in patients with spinal cord injury Title

Population

Intervention

Primary Outcomes

Phase

Country

Status

Patients with SCI and neurogenic bowel or bladder

Telehealth program called “Health Mechanics” aimed at improving selfmanagement skills related to neurogenic bladder and neurogenic bowel management.

Spinal Cord Injury Quality of Life (SCI-QOL) (Change from baseline at 6 month assessment)

NP

USA

Currently enrolling patients

Phase 2

USA

Completed

Bowel and Bladder Health Evaluation of Bowel and Bladder Health Management for Individuals with Spinal Cord 36 Injury

-

Emotional Domain Physical Domain Social Domain

Bowel and Bladder Treatment Index (Change from baseline at 6 month assessment) Bowel Health Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With 39 SCI (IN NEO)

Patients with SCI

Intranasal administration of Neostigmine Intranasal administration of Neostigmine and Glycopyrrolate Intravenous administration of Neostigmine and Glycopyrrolate

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Bowel Evacuation Time Frame