[Table, Recommendations and links to evidence]. - Urinary Incontinence in Neurological Disease

Recommendations:	MONITORING AND SURVEILLANCE PROTOCOLS 56. Do not rely on serum creatinine and estimated glomerular filtration rate in isolation for monitoring renal function^p in people with neurogenic lower urinary tract dysfunction. 57. Consider using isotopic glomerular filtration rate when an accurate measurement of glomerular filtration rate is required (for example, if imaging of the kidneys suggests that renal function might be compromised)^p. 58. Offer lifelong ultrasound surveillance of the kidneys to people who are judged to be at high risk of renal complications (for example, consider surveillance ultrasound scanning at annual or 2 yearly intervals). Those at high risk include people with spinal cord injury or spina bifida and those with adverse features on urodynamic investigations such as impaired bladder compliance, detrusor-sphincter dyssynergia or vesicoureteric reflux. 59. Do not use plain abdominal radiography for routine surveillance in people with neurogenic lower urinary tract dysfunction. 60. Consider urodynamic investigations as part of a surveillance regimen for people at high risk of urinary tract complications (for example, people with spina bifida, spinal cord injury or anorectal abnormalities). 61. Do not use cystoscopy for routine surveillance in people with neurogenic lower urinary tract dysfunction. 62. Do not use renal scintigraphy for routine surveillance in people with neurogenic lower urinary tract dysfunction.
Relative value placed on the outcomes considered	The outcomes included in the review were: kidney function and renal disease, quality of life and hospital admissions. The GDG considered that detecting silent disease to be an important outcome as early intervention may prevent more progressive renal damage.
Quality of evidence	Seventeen observational studies evaluating creatinine, ultrasound, cystoscopy and renal scintigraphic scanning were found. The majority of studies were retrospective observational studies without a control group. The overall quality of the evidence was low. A number of the studies reported on interventions that were performed only once and therefore did not form part of an ongoing monitoring and surveillance programme. The GDG made recommendations on the basis of a very limited evidence base and no studies demonstrated outcomes from routine surveillance/monitoring that matched requirements for the adoption of screening programmes. The recommendations were made by consensus based on existing practice and deductions from the studies that have been examined. Eight studies on the use of ultrasound for spinal cord injury patients and two for spina bifida patients supported its routine use. The GDG noted that the studies all produced reasonable results (between 15–30%) in finding abnormalities The GDG agreed that the use of Serum Creatinine in isolation has been shown to be unreliable because of a number of factors (most importantly – muscle mass). One study on cystoscopy did not support its use and one study on renal scintigraphic scans did not support routine long term use. One study on cystoscopy suggested that it may be possible to improve outcomes for patients with spinal cord injury who develop bladder cancer through surveillance cystoscopy, but the study was inconclusive, and the GDG agreed that this study should not be considered
Trade-off between clinical benefits and harms	The GDG noted the surveillance being advocated minimises exposure to ionising radiation. The GDG agreed that abdominal X-ray should not be recommended because of the associated risks but noted that some centres continue to use abdominal radiography in this context. The GDG considered that lifelong ultrasound was appropriate for those people who were at high risk of renal complications such as the development of hydronephrosis or the formation or renal stones and this was current practice for particular groups such as those with spinal cord injury or spina bifida. The question of using cystoscopy as a screening tool for bladder cancer was considered. It was noted that while the incidence of bladder cancer is probably raised in some populations with neurogenic lower urinary tract dysfunction, it remains a relatively rare condition. Therefore the morbidity of routine cystoscopy and resource implications suggests that it is unlikely that cystoscopy would meet the requirements for use as a screening test. The GDG emphasized the importance of early referral of patients with red flag symptoms.
Economic considerations	An extensive cost analysis was done on the various monitoring programmes recommended by different published guidelines. This analysis showed that over ten years of monitoring, None of the strategies compared are associated with considerable costs. The most expensive strategy was under £3,000 for a ten year period. No effectiveness data or quality of life data could be found that matched the interventions; therefore a full economic evaluation could not be carried out. We conducted a threshold sensitivity analysis on the number of incremental QALYs that each strategy would have to generate compared to ‘do nothing’ in order to be cost-effective at a threshold of £20,000/QALY. Over ten years the QALYs gain would have to be 0.13 for the most costly strategy or less than this for the other strategies. The GDG considered this number to be low for a ten year period; therefore the monitoring strategies compared in the cost analysis are likely to be cost-effective. However, our analysis does not consider the unnecessary treatment associated with the ‘false positive’ cases resulting from the monitoring strategies. These would lead to unnecessary treatments and further investigation, making the monitoring strategy less cost effective. Strategies assessed here included regular eGFR measurements, ultrasound and cystoscopy as well as other techniques involved in renal surveillance. All of these strategies were judged to be low cost therefore lifelong renal surveillance and the individual components that make this up could be recommended.
Other considerations	The GDG agreed that isotopic techniques are widely regarded as being the most accurate of the available techniques for measuring the glomerular filtration rate. The GDG acknowledged that the interval between monitoring visits was, in general, arbitrarily set at one year. However, it was felt that it was important to tailor surveillance to the individual patient’s circumstances. Some patients with adverse factors, such as concerning urodynamic findings or a history of frequent stone formation, might need to be seen more often than once a year. On the other hand, some patients who were in low risk groups, such as female MS patients, might not require regular surveillance investigations at all.

Recommendations:

MONITORING AND SURVEILLANCE PROTOCOLS

56.: Do not rely on serum creatinine and estimated glomerular filtration rate in isolation for monitoring renal function^p in people with neurogenic lower urinary tract dysfunction.
57.: Consider using isotopic glomerular filtration rate when an accurate measurement of glomerular filtration rate is required (for example, if imaging of the kidneys suggests that renal function might be compromised)^p.
58.: Offer lifelong ultrasound surveillance of the kidneys to people who are judged to be at high risk of renal complications (for example, consider surveillance ultrasound scanning at annual or 2 yearly intervals). Those at high risk include people with spinal cord injury or spina bifida and those with adverse features on urodynamic investigations such as impaired bladder compliance, detrusor-sphincter dyssynergia or vesicoureteric reflux.
59.: Do not use plain abdominal radiography for routine surveillance in people with neurogenic lower urinary tract dysfunction.
60.: Consider urodynamic investigations as part of a surveillance regimen for people at high risk of urinary tract complications (for example, people with spina bifida, spinal cord injury or anorectal abnormalities).
61.: Do not use cystoscopy for routine surveillance in people with neurogenic lower urinary tract dysfunction.
62.: Do not use renal scintigraphy for routine surveillance in people with neurogenic lower urinary tract dysfunction.

Relative value placed on the outcomes considered

The outcomes included in the review were: kidney function and renal disease, quality of life and hospital admissions. The GDG considered that detecting silent disease to be an important outcome as early intervention may prevent more progressive renal damage.

Quality of evidence

Seventeen observational studies evaluating creatinine, ultrasound, cystoscopy and renal scintigraphic scanning were found. The majority of studies were retrospective observational studies without a control group. The overall quality of the evidence was low. A number of the studies reported on interventions that were performed only once and therefore did not form part of an ongoing monitoring and surveillance programme.
The GDG made recommendations on the basis of a very limited evidence base and no studies demonstrated outcomes from routine surveillance/monitoring that matched requirements for the adoption of screening programmes. The recommendations were made by consensus based on existing practice and deductions from the studies that have been examined.
Eight studies on the use of ultrasound for spinal cord injury patients and two for spina bifida patients supported its routine use. The GDG noted that the studies all produced reasonable results (between 15–30%) in finding abnormalities
The GDG agreed that the use of Serum Creatinine in isolation has been shown to be unreliable because of a number of factors (most importantly – muscle mass).
One study on cystoscopy did not support its use and one study on renal scintigraphic scans did not support routine long term use. One study on cystoscopy suggested that it may be possible to improve outcomes for patients with spinal cord injury who develop bladder cancer through surveillance cystoscopy, but the study was inconclusive, and the GDG agreed that this study should not be considered

Trade-off between clinical benefits and harms

The GDG noted the surveillance being advocated minimises exposure to ionising radiation. The GDG agreed that abdominal X-ray should not be recommended because of the associated risks but noted that some centres continue to use abdominal radiography in this context.
The GDG considered that lifelong ultrasound was appropriate for those people who were at high risk of renal complications such as the development of hydronephrosis or the formation or renal stones and this was current practice for particular groups such as those with spinal cord injury or spina bifida.
The question of using cystoscopy as a screening tool for bladder cancer was considered. It was noted that while the incidence of bladder cancer is probably raised in some populations with neurogenic lower urinary tract dysfunction, it remains a relatively rare condition. Therefore the morbidity of routine cystoscopy and resource implications suggests that it is unlikely that cystoscopy would meet the requirements for use as a screening test. The GDG emphasized the importance of early referral of patients with red flag symptoms.

Economic considerations

An extensive cost analysis was done on the various monitoring programmes recommended by different published guidelines. This analysis showed that over ten years of monitoring, None of the strategies compared are associated with considerable costs. The most expensive strategy was under £3,000 for a ten year period. No effectiveness data or quality of life data could be found that matched the interventions; therefore a full economic evaluation could not be carried out. We conducted a threshold sensitivity analysis on the number of incremental QALYs that each strategy would have to generate compared to ‘do nothing’ in order to be cost-effective at a threshold of £20,000/QALY. Over ten years the QALYs gain would have to be 0.13 for the most costly strategy or less than this for the other strategies. The GDG considered this number to be low for a ten year period; therefore the monitoring strategies compared in the cost analysis are likely to be cost-effective. However, our analysis does not consider the unnecessary treatment associated with the ‘false positive’ cases resulting from the monitoring strategies. These would lead to unnecessary treatments and further investigation, making the monitoring strategy less cost effective.
Strategies assessed here included regular eGFR measurements, ultrasound and cystoscopy as well as other techniques involved in renal surveillance. All of these strategies were judged to be low cost therefore lifelong renal surveillance and the individual components that make this up could be recommended.

Other considerations

The GDG agreed that isotopic techniques are widely regarded as being the most accurate of the available techniques for measuring the glomerular filtration rate.
The GDG acknowledged that the interval between monitoring visits was, in general, arbitrarily set at one year. However, it was felt that it was important to tailor surveillance to the individual patient’s circumstances. Some patients with adverse factors, such as concerning urodynamic findings or a history of frequent stone formation, might need to be seen more often than once a year. On the other hand, some patients who were in low risk groups, such as female MS patients, might not require regular surveillance investigations at all.

From: 14, Monitoring and surveillance protocols

Cover of Urinary Incontinence in Neurological Disease

Urinary Incontinence in Neurological Disease: Management of Lower Urinary Tract Dysfunction in Neurological Disease.

NICE Clinical Guidelines, No. 148.

National Clinical Guideline Centre (UK).

London: Royal College of Physicians (UK); 2012 Aug.

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