Stress urinary incontinence arises where the function of the urethral sphincters and or pelvic floor muscles are compromised; leakage of urine can occur if intra-abdominal pressure is raised, even in the absence of a contraction of the detrusor muscle of the bladder wall. Sphincteric or pelvic floor muscle deficiency is seen in patients who have sustained damage to the sacral segments of the spinal cord, the cauda equina or peripheral nerves within the pelvis. The use of indwelling urethral catheters in patients with neurologenic lower urinary tract dysfunction (NLUTD) is a well-recognised risk factor; tension on a urethral catheter can cause pressure necrosis of the urethral sphincters. Patients who lack urethral sensation or who are cognitively-impaired are at particular risk of sustaining catheter-related urethral damage. Stress incontinence in patients who have neurological disease can, of course, have a non-neurological aetiology such as pelvic floor hypermobility that has resulted from previous pregnancies and childbirth.
Many patients with neurogenic stress incontinence who request treatment of the condition are already using intermittent self-catheterisation to empty their bladders. However, for patients who empty the bladder without using a catheter, for example by using abdominal straining, it is important to recognise that effective treatment of stress incontinence will, almost inevitably, precipitate urinary retention which will necessitate the introduction of intermittent catheterisation or the use of an indwelling suprapubic catheter.
Pelvic floor muscle training is widely used in the neurologically intact population with stress incontinence of urine and is supported by evidence of efficacy in the NICE Female Urinary Incontinence Guideline 125 However, the use of pelvic floor muscle training in patients with NLUTD has received relatively little attention. Patients who retain the ability to voluntarily contract their pelvic floor muscles, despite their neurological deficit, are candidates for pelvic floor muscle training programmes as they have the potential to improve the strength and responsiveness of their pelvic floor musculature. A variety of techniques that might improve the outcomes of pelvic floor muscle training have been described; these include electrical stimulation of the pelvic floor and biofeedback systems. However, there is limited information about the treatment regimes that should be used in patients with NLUTD as well as uncertainty about the effectiveness of the treatment.
A wide range of surgical procedures have been used to treat stress incontinence in patients with NLUTD. The most commonly used approaches involve either providing passive support or compression of the urethra using urethral slings or providing active compression using the artificial urinary sphincter. Slings can be made either from the patient’s own tissues (for example autologous rectus sheath) or from synthetic materials.
Sling surgery is well-established in the management of stress incontinence in the non-neuropathic female population 125 but it is not possible to extrapolate from the neurologically intact population to patients with NLUTD as the pathophysiology of stress incontinence differs between the two groups. In the neuropathic population it is usually the case that there is damage to the function of the muscle of the urethral sphincter (intrinsic sphincter deficiency) while in neurologically intact patients, excessive mobility of the urethra is the commonest cause of stress incontinence. This is an important distinction as it is generally believed that successful treatment of neuropathic stress incontinence is dependent on a sling compressing the urethra rather than simply preventing descent of the urethra from its normal anatomical position.
To date, autologous tissue has been regarded as the standard sling material to use when managing neuropathic stress incontinence. The perceived need for some tensioning of the sling raises the question as to whether synthetic material should be used in view of there being a theoretical increased risk of a synthetic sling or tape eroding through the wall of the urethra. Despite the fact that sling surgery has been widely used to manage neuropathic stress incontinence, there is relatively little published data on the benefits and risks of this therapeutic option.
For thirty years, the artificial urinary sphincter has been used to manage stress incontinence in neuropathic patients both alone and in combination with other reconstructive procedures 126. The AMS 800 (American Medical Solutions) is the only device that has been in widespread use. It works on a hydraulic principle. A pressure-generating reservoir supplies fluid to a cuff-mounted balloon which is fitted around the urethra. As the pressures in the two components equalises, the urethral lumen is occluded and continence aided. The patient uses a pump to empty the cuff balloon and transfer fluid back to the reservoir which then allows voiding to take place or a catheter to be passed. Although high continence rates are reported for patients undergoing artificial urinary sphincter implantation, surgical complication rates and the cost of the device have to be taken into consideration when evaluating the implant’s role.
9.1. Pelvic floor treatments
9.1.1. Does pelvic floor muscle training with or without electrical stimulation or biofeedback compared with treatment as usual, improve outcomes?
9.1.1.1. Clinical Evidence
We searched for RCTs comparing the effectiveness of pelvic floor muscle training with or without electrical stimulation or biofeedback as interventions for improving outcomes for incontinence due to multiple sclerosis or stroke. These conditions were selected as they represented the main diagnostic groups in which pelvic floor muscle training is used in neurogenic LUT dysfunction in clinical practice. We looked for any RCT studies that compared the effectiveness of pelvic floor muscle training with or without electrical stimulation or biofeedback with treatment as usual.
Five RCTs were identified comparing pelvic muscle training for improving incontinence due to neurological disease/injury. All of the RCTs were in the adult population. summarises the population, intervention, comparison and length of follow up for each of the studies.
Summary of studies included in the clinical evidence review.
Comparison of pelvic floor training and advice (PFTA) versus PFTA plus electromyography (EMG) versus PFTA plus EMG plus neuromuscular electrical stimulation (NMES)
Table 81. GRADE profile - PFTA versus PFTA plus EMG versus PFTA plus EMG plus NMES
Narrative summary (for outcomes that are not appropriate for GRADE due to incomplete outcome reporting)
Kings Health Questionnaire (KHQ)
Throughout the duration of the study, results for the KHQ were variable both within and between groups, however significant improvements were demonstrated in the Symptom Severity Scale in the PFTA + EMG and PFTA + EMG + NMES groups at all time points (p ≤ 0.034)130
Multiple sclerosis quality of life (MSQoL-54)
Throughout the duration of the study, results for the MSQoL-54 were variable both within and between groups, however significant improvements were demonstrated in the cognitive function sub-scale at all time points in PFTA + EMG + NMES (p ≤ 0.016). In addition, statistically significant improvements were also observed in the emotional well-being sub-scale in PFTA + EMG and PFTA + EMG + NMES (week 24; p ≤ 0.027)130
Adherence
Attendance at the weekly clinic sessions averaged 78% in all groups. Home use of the EMG unit was 75% recommended. No major effects or problems with usage were indicated 130.
9.1.1.2. Economic evidence
No relevant economic evaluations comparing pelvic floor muscle training, with or without electrical stimulation or biofeedback were identified.
Unit costs
In the absence of recent UK cost-effectiveness analysis, relevant unit costs are provided in to aid consideration of cost effectiveness.
Economic considerations
No evidence could be found that suggested that pelvic floor training is cost-effective in neuropathic patients with urological incontinence. The cost of pelvic floor training, with or without electrical stimulation or biofeedback is unlikely to be high, as shown in the unit costs above. While the costs of these programmes are not insignificant, the GDG felt that if effective this cost may be offset by the reduced costs associated with a reduction in the use of incontinence aids.
9.1.1.3. Evidence Statements
Clinical Evidence Statements
Pelvic floor muscle training (PFMT) versus sham in patients with multiple sclerosis
One study comprising 27 participants found that a statistically significant lower proportion of patients receiving pelvic floor muscle training compared to sham had:
One study comprising 27 participants found no significant difference between pelvic floor muscle training and sham for:
Nocturnal enuresis (12 weeks) (low quality)
Incomplete emptying (12 weeks) (low quality)
No. of sessions attended (12 weeks) (low quality)
PFMT plus electrical stimulation compared with control in patients with multiple sclerosis
One study comprising 80 participants found that a statistically significant lower proportion of patients receiving pelvic floor muscle training compared with control had:
PFMT plus electromyography feedback (EMG) plus neuromuscular electrical stimulation (NMES) compared with pelvic floor muscle training plus EMG in patients with multiple sclerosis
One study comprising 74 participants found no significant difference in:
Evidence statements could not be produced for the following outcomes of the studies by McClurg 134 as the results were presented of the intervention effect in a way that meant we could not estimate the size of the intervention effect :
Comparison of pelvic floor training and advice (PFTA) versus PFTA plus electromyography (EMG) versus PFTA plus EMG plus neuromuscular electrical stimulation (NMES)
One study of 30 participants found no significant difference for each group (PFTA, PFTA + EMG, PFTA + EMG + NMES) when comparing pre vs post treatment values for:
Evidence statements could not be produced for the following outcomes of the study by McClurg 130 as the results were presented of the intervention effect in a way that meant we could not estimate the size of the intervention effect :
Incontinence Impact Questionnaire total score
Leakage episodes per 24 hr
Post-void residual urine
Kings Health Questionnaire
Pelvic floor muscle training plus electrical stimulation compared with control in patients with stroke
One study comprising 18 participants found no significant difference for PFMT compared with control for:
Evidence statements could not be produced for the following outcomes of the study by Tibaek 132; 131 as the results were presented of the intervention effect in a way that meant we could not estimate the size of the intervention effect :
SF36 total score (6 months) (very low quality).
Incontinence Impact Questionnaire (6 months) (very low quality).
No. of incontinence episodes/24 hr (12 weeks) (very low quality)
Economic evidence statements
While the costs of these programmes are not insignificant, the GDG felt that if effective this cost may be offset by the reduced costs associated with a reduction in the use of incontinence aids
9.1.2. Recommendations and links to evidence
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| Recommendations: | PELVIC FLOOR MUSCLE TRAINING
- 40.
Consider pelvic floor muscle training for people with: Select patients for this training after specialist pelvic floor assessment and consider combining treatment with biofeedback and/or electrical stimulation of the pelvic floor.
|
|---|
| Relative value placed on the outcomes considered | The GDG considered the outcomes of urinary continence, nocturia and quality of life to be important. |
| Quality of evidence | Overall, the evidence showed that pelvic floor muscle training with or without electrical stimulation or feedback improved continence outcomes. Although some quality of life data was available, it was not presented in a format that could be analysed using the GRADE methodology. The GDG recognised that the evidence presented is graded as being of generally low or very low quality. The sample sizes were small and follow up periods were generally short. The GDG noted that the evidence was limited predominately to patients with multiple sclerosis. The very limited evidence in the stroke population was in women only although there was some uncertainty regarding the clinical effectiveness of the interventions, the GDG agreed that overall there was sufficient evidence to suggest an improvement in continence outcomes. These improvements had the potential to improve quality of life.
No economic evidence was found on pelvic floor muscle training. The GDG made their considerations on the basis of unit costs of staff time. |
| Trade-off between clinical benefits and harms | The GDG agreed that the interventions had the potential to deliver clinical benefit, improve patient/carer quality of life with very limited risk of harm. The GDG noted that the two studies (Lucio 2010; Vahtera) that compared pelvic floor muscle training interventions with sham or no treatment indicated there was some benefit in offering treatment, although the limitations of the studies were acknowledged. The group noted the significant improvement in the symptom severity scale and quality of life outcomes shown in the McClurg (2006) study. The group agreed that stress incontinence can cause distress to the patient and for some people these interventions may help alleviate this. |
| Economic considerations | While the costs of pelvic floor muscle training programmes are not negligible, particularly with respect to staff time, if effective, their cost may be offset by the cost-savings associated with a reduction in the use of incontinence aids. |
| Other considerations | Pelvic floor muscle exercises are often advised to be undertaken for patients with neurological conditions such as MS to prevent urinary incontinence and control urgency. These exercises are often advocated for use in the earlier stages of disease. Basic instruction can be provided by one of the patient’s usual treating clinicians, such as an MS nurse but, it is important that the patient is undertaking the exercises correctly and if they express uncertainty then referral to a specialist continence advisor or physiotherapist is required. The use of adjuncts such as electrical stimulation or biofeedback can then be offered by these specialists. The GDG considered that the evidence review did not fully capture the complexity of treating NLUTD patients using pelvic floor training and that it would be wrong to exclude the possibility of using electrical stimulation and biofeedback as there may be particular circumstances where a therapist will find such techniques valuable. The GDG noted that patients with very weak pelvic floor muscle contraction or poor sensation, such as patients with MS, can benefit from biofeedback or electrical stimulation as it can aid motivation to continue the pelvic floor exercises. |
9.2. Urethral tape and sling surgery
9.2.1. What is the safety and efficacy of urethral tape and sling surgery compared with a) bladder neck closure b) usual care in neurological disease?
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| Clinical Methodological Introduction |
|---|
| Population: | Patients with incontinence due to neurogenic lower urinary tract dysfunction (NLUTD) |
| Intervention: | Urethral tape and sling surgery |
| Comparison: | Bladder neck closure
Usual care |
| Outcomes: | Number of incontinence episodes per week.
Severity of incontinence.
Symptoms relating to bladder emptying, for example poor urinary stream, need for intermittent catheterisation.
Quality of life.
Patients and carers’ perception of symptoms.
Adverse events, including urinary tract infections, renal complications, bladder stones and unscheduled hospital admissions.
Damage caused by catheterisation |
9.2.1.1. Clinical review
We searched for RCTs and observational studies comparing the effectiveness of urethral tape and sling surgery as interventions for improving outcomes in patients with incontinence due to NLUTD. We looked for any RCT or observational studies that compared the effectiveness of urethral tape and sling surgery with bladder neck closure or with treatment as usual.
24 observational studies were identified. Four observational studies were on tape or synthetic sling surgery 135
136
137
138 and 20 were on sling surgery 139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158. No studies were identified comparing urethral tape or sling surgery with bladder neck closure. The evidence is presented according to whether the population was adults or adults and children (mixed) or children. The evidence is also presented according to whether augmentation cystoplasty was performed (either before or at the same time as the tape or sling surgery) or not.
Quality of included studies
Overall, the studies were observational studies of very low quality. The vast majority of studies were before and after studies. Most importantly, there were no attempts to eliminate threats to internal validity through the use of a matched comparison group, although in most studies patients had failed to respond to a period of antimuscarinic medication and intermittent self catheterisation, and so it is unlikely that confounding time effects could wholly explain the changes seen from before to after surgery.
and summarise the population, intervention, comparison and length of follow up for each of the studies.
Synthetic Tapes and Slings - Summary of studies included in the clinical evidence review.
Autologous and Biological Slings – Summary of studies included in the evidence review. (N.B. Hershorn includes two patients with synthetic slings)
Quality of studies
Tapes and slings
Definitions of incontinence were almost always lacking, and so it is unclear what level of severity was used as the threshold measure of “incontinence”. Several studies also failed to clarify the number of patients suffering from incontinence pre-operatively, although in most cases it was implicit that the majority were suffering from incontinence at baseline.
Tapes
Continence outcome
Table 86Synthetic Tapes and Slings – No. continent
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| Study | Pre-surgery (frequency) | Post-surgery (frequency) |
|---|
| Dean135 | 0/6 | 5/6 (completely dry) |
| Godbole 2003136 | 0/17 implied | 15/17 (initially dry)
4/17 (dry long-term) |
| Hamid 2003137 | 0/12 | 10/12 |
Abdul-Rahmana138
5 yr follow up
10 yr follow up |
0/12
0/9 |
10/12
7/9 |
- a
Same patients as in Hamid 2003
Quality of life outcome
The study reported the ‘no. of patients’ satisfied and did not use a validated measure of quality of life.
Table 87Synthetic Tapes and Slings – Health related quality of life (no. of patients ‘satisfied’)
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| Study | Pre-surgery (frequency) | Post-surgery (frequency) |
|---|
| Abdul-Rahman 138 | | |
| 5 yr follow up | Not applicable | 11/12 |
| 10 yr follow up | | 9/9 |
Synthetic Tapes and Slings
Adverse events
Table 88Synthetic Tapes and Slings – No. with adverse events
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| Study | Any adverse event (frequency) | Urinary tract infections(frequency) | Reoperation (frequency) |
|---|
| Dean135 | Not reported | Not reported | 3/6 |
| Godbole 2003136 | 0/17 | | 14/17 sling removal due to erosion |
Table 89Synthetic Tapes and Slings – Damage caused by catheterisation
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| Study | Damage caused by catheterisation (frequency) | Difficulties caused by catheterisation (frequency) |
|---|
| Dean135 | 0/5 urethral erosion | Not reported |
| Godbole 2003136 | | 17/17 (unable to catheterise urethrally) |
Table 90Synthetic Tapes and Slings – No. with urinary tract infection
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| Study | Pre-surgery (frequency) | Post-surgery (frequency) |
|---|
| Hamid 2003137 | Not applicable | 3/12 |
Autologous and Biological Slings
Continence outcome
The results are presented in and .
Autologous and Biological Slings - No. continent.
Autologous and Biological Slings - Severity of incontinence.
Adverse events
The majority of studies did not specify what adverse events were actively monitored ().
Autologous and Biological Slings - Adverse events reported by patients undergoing sling surgery.
Damage caused by catheterisation
Autologous and Biological Slings - Damage caused by catheterisation.
9.2.1.2. Economic evidence
No relevant economic evaluations comparing urethral tape and sling surgery with bladder neck closure were identified.
Unit costs
In the absence of recent UK cost-effectiveness analysis, relevant unit costs are provided in to aid consideration of cost-effectiveness.
Economic considerations
These interventions (bladder neck open procedures) are categorized in the same Healthcare Resource Group (HRG) codes, costing £1,419 for females (LB23Z, NHS reference cost 2009–10), and £4,617 for males (LB21Z, NHS reference cost 2009–10). However, the unit cost of a tape is not included in the cost of the operation, therefore an additional cost of £632 should be added to the operation cost.
These interventions are currently performed in selective patients and as the difference in costs is negligible, the recommendation should be based on clinical grounds. The cost of these interventions is fairly high, however if shown to be effective, the costs could be offset by a reduction in the costs of incontinence aids and an increase in quality of life. The sling operation is marginally cheaper than the cost of synthetic tape surgery, as the sling is made of human tissue and therefore no extra cost is incurred. However, with no useful effectiveness data it is difficult to draw conclusions on the cost effectiveness of either intervention. If the effectiveness of the two operations is considered equivalent, then autologous sling surgery is likely to be cost saving.
9.2.1.3. Evidence Statements
Narrative summary
Synthetic Tapes and Slings
Four observational studies (two of the same population) (27.1 mths to 10 yrs) (very low quality) suggested that synthetic tapes and slings were associated with an improvement in continence. Adverse events include reoperation, difficulties caused by catheterisation and urinary tract infections.
Autologous and Biological Slings
Adults with augmentation
Two observational studies (14.25 to 34.3 mths) (very low quality) reported an improvement in continence. Adverse events included Marlex erosions, urinary tract infections and re-operation.
Children with augmentation
Five observational studies (10.3 to 15 mths) (very low quality) reported an improvement in continence. Adverse events included erectile dysfunction and difficulties with catheterisation.
Children without augmentation/unknown
Six observational studies (10 to 36 mths) (very low quality) reported an improvement in continence. Adverse events included vesicovaginal fistula, re-operation and difficulties with catheterisation
Mixed/unknown with augmentation cystoplasty
Seven observational studies reported an improvement with continence (12 mths to 5 yrs) (very low quality). Adverse events included bladder neck occlusion, asymptomatic bacteriuria and difficulties with catheterisation.
Mixed/unknown without augmentation/unknown
One observational study (39 mths) (very low quality) reported an improvement in continence.
Economic evidence statements
Autologous and biological sling surgery is marginally cheaper than synthetic tape and sling surgery, however as the two operations are already done on highly selected populations, the direct comparison is not necessarily relevant.
If the
effectiveness of the two operations are considered equivalent, then autologous sling surgery is likely to be cost saving compared to synthetic taping.
9.2.2. Recommendations and links to evidence
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| Recommendations: | URETHRAL TAPE AND SLING SURGERY
- 41.
Consider autologous fascial sling surgery for people with neurogenic stress incontinence. - 42.
Do not routinely use synthetic tapes and slings in people with neurogenic stress incontinence because of the risk of urethral erosion.
|
|---|
| Relative value placed on the outcomes considered | The GDG placed a high value on the outcome of continence however the lack of data on quality of life was noted. |
| Quality of evidence | Overall, the studies were observational studies of very low quality. The majority of studies compared status before with after surgery. Most importantly, there were no attempts to eliminate threats to internal validity through the use of a matched comparison group, although in most studies patients had failed to respond to a period of antimuscarinic medication and intermittent self catheterisation, and so it is unlikely that confounding time effects could wholly explain the changes seen from before to after surgery. In general, longer-term follow-up data was not reported in the studies. There was a lack of evidence for quality of life. For children, the majority of data was on patients with spinal bifida. The GDG noted that there was variation in the surgical techniques used.
The very limited and low quality data on synthetic tapes and slings reported an improvement in continence. However, the surgery was also associated with a need for reoperation and increased incidence on urinary tract infections (UTIs). The data on autologous and biological slings was of very low quality, but the studies demonstrated that surgery was associated with an improvement in continence pre vs post surgery in those with and without augmentation cystoplasty. The overall rate of adverse events ranged from 2 to 24%. The incidence of UTIs ranged from 0 to 54% and the frequency of reoperation ranged from 12 to 23% |
| Trade-off between clinical benefits and harms | Urethral sling procedures are capable of rendering a proportion of patients with neurogenic stress incontinence continent.
There are associated risks which include the possibility of damage to the urethra or bladder during or after surgery. The GDG considered that tapes or slings that are made from synthetic materials are likely to carry an excess risk of tissue erosion and local infection. Furthermore there is extremely limited data available for synthetic tape procedures.
Stress incontinence frequently coexists with abnormal bladder storage due to detrusor overactivity or impaired compliance in patients with NLUTD. Therefore it is common for a patient to undergo a combined operation that is designed to treat the abnormality of sphincter and bladder function. The case series that have been reviewed illustrate this as many include patients who have undergone sling surgery and augmentation cystoplasty. The GDG felt that It is important to recognise that upper tract deterioration can be associated with the treatment of stress incontinence in patients with NLUTD if bladder storage pressures are high. Bladder storage requires thorough pre-operative assessment. Post-operative upper urinary tract surveillance should be maintained. A subsequent augmentation cystoplasty may be required if bladder storage is unsafe. |
| Economic considerations | The GDG considered the costs of slings and tapes and the surgeries required to install them. The surgeries are high cost but the GDG considered that the costs are likely to be offset by the long term reduction in the use of continence aids. In addition, the GDG thought they would improve the quality of life of the patient due to the reduced incontinence.
These interventions are currently performed in selective patients and as the difference in costs is negligible, the recommendation should be based on clinical grounds. The cost of these interventions is fairly high, however if shown to be effective, the costs could be offset by a reduction in the costs of incontinence aids and an increase in quality of life. The sling operation is marginally cheaper than the cost of synthetic tape surgery, as the sling is made of human tissue and therefore no extra cost is incurred. However, with no useful effectiveness data it is difficult to draw conclusions on the cost effectiveness of either intervention. If the effectiveness of the two operations is considered equivalent, then autologous sling surgery is likely to be cost saving. |
| Other considerations | The GDG noted that whilst there is a risk of damage to the urethra or bladder for any patient having this procedure it is particularly high in the neuropathic population due to the anatomical changes that can be present and the effects of chronic inflammation in the tissues. |
9.3. Artificial urinary sphincter
9.3.1. What is the safety and efficacy of artificial urinary sphincters compared with other treatments in neurological disease?
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| Clinical Methodological Introduction | |
|---|
| Population: | Children and adults with stress urinary incontinence resulting from neurological disease |
| Intervention: | Implantation of an artificial urinary sphincter |
| Comparison: | Other treatments; however no studies made such comparisons, and all compared findings before and after implantation. |
| Outcomes: |
Incontinence – frequency and severity Symptoms relating to bladder emptying Adverse events, including UTIs, renal complications, bladder stones, infection of prosthesis, device failure and unscheduled hospital admissions.
|
9.3.1.1. Clinical evidence
We searched for observational studies that examined the effectiveness of implantation of an artificial urinary sphincter in improving incontinence in people with NLUTD. We looked for any observational studies that compared the effectiveness of implantation of an artificial urinary sphincter with other treatments, but only one study 159 used a comparison group. All studies compared findings before implantation with those after implantation, and these results form the main body of this report.
25 observational studies were identified which evaluated the effects of artificial sphincter implantation on incontinence in neurological disease. The implantation procedures and prostheses used were fairly homogenous across the studies. The only outcomes addressed by these studies were incontinence and adverse events. summarises the population characteristics in each study.
Summary of studies included in the clinical evidence review.
Quality of studies
The confidence in the findings reported below is undermined by the lack of attempts to eliminate threats to internal validity through the use of a matched group. Definitions of incontinence were often lacking, and so it is unclear what was the threshold measure. Several studies also failed to clarify the number of patients suffering from incontinence pre-operatively, although in most cases it was implicit that the large majority were suffering from incontinence at baseline.
Incontinence outcome
Pre-test to post-test comparisons
All studies suggested that artificial sphincters would reduce the likelihood of incontinence, through a comparison of incontinence before and after the sphincter implantation, and this did not appear to vary by age group. shows results for these studies.
Effects of artificial sphincters on incontinence.
Comparison to other treatments
Sidi 1987159 compared a group of 16 young people of mean age 17.2 years (range 5–44) who had undergone an artificial sphincter implantation to a group of 9 young people of mean age 16.3 years (range 4–27) who had undergone a Young-Dees-Leadbetter bladder neck reconstruction. The mean (sd) postoperative continence score (0–5 range, and a higher score is better) in the artificial sphincter group was 3.62 (0.7) and in the bladder neck reconstruction group was 3.72 (0.9). This difference was not statistically significant (see Appendix B). This was not a randomised trial, and these results are therefore prone to bias from factors such as varying diagnoses.
Adverse events (post implantation)
A variety of adverse effects of the implantation were reported, and the most important ones are documented in the tables below, with the following data concerning patients affected at least once. The most prominent risks are the need for revision (34%), device failure (26%), the need for complete removal (22%), bladder neck erosion or device infection (11%), UTIs (9%) and upper tract complications (8%). There appears to be no risk for mortality. Note that the lack of reporting of an adverse event does not necessarily imply the adverse event was absent, as some events may only be detected if actively sought. It was not possible to make a meaningful comparison of the incidence in adults and children, as only two studies had exclusively adult patients, most data being from studies with mixed-age groups. outlines these results, with a summary for each age group and overall. The only study Sidi 1987159 to compare artificial sphincter implantation to another treatment did not report adverse events.
9.3.1.2. Economic evidence
No relevant economic evaluations comparing the use of the artificial urinary sphincter with sling surgery or other treatments were identified.
Unit costs
In the absence of recent UK cost-effectiveness analysis, relevant unit costs are provided in to aid consideration of cost-effectiveness.
Economic considerations
The comparison relevant for this question is artificial urinary sphincter versus sling surgery. These interventions are categorized in the same HRG code, costing £4,617 for men and £1,419 for women (LB23Z and LB21Z, NHS reference cost 2009–10). There is however the additional cost to consider of the artificial sphincter itself, which costs £4,119 (Personal communication Mid Yorkshire Hospitals NHS Trust). In current practice, the choice of procedure is made on the basis of surgeon preference.
The clinical review has not shown any significant clinical advantage over other interventions with similar aims. Added to which the clinical review has shown that the rate of re-operation and adverse effects associated with artificial sphincter implantation is quite high, adding to the long term costs and reductions in quality of life. It is estimated by the GDG and on the basis of data from several studies that the re-operation rate on artificial sphincters is one re-operation/replacement of the device every ten years183,183. This means that there are additional life-time costs for many patients who have artificial urinary sphincters implanted as a result of the need to manage complications and undertake revisional surgery.
Therefore the cost of alternative surgical options, such as sling surgery, are likely to be considerably lower as a result of there being a requirement for fewer re-operations. This will also be likely to have a quality of life advantage. On this basis, the artificial sphincter is not considered to be cost-effective when compared to sling surgery in circumstances where the procedures would be expected to have similar success rates in treating stress incontinence.
9.3.1.3. Evidence Statements
Clinical evidence statements
22 Observational studies comprising 695 participants suggested that artificial sphincter implantation might improve incontinence (3 – 208 months) (very low quality)
24 Observational studies comprising 835 participants suggested that the main adverse effects of artificial sphincter implantation are device failure (26%), device infection/bladder neck erosion (12%), the need for revision (34%), the need for complete removal (22%), 11UTIs (9%), and upper tract complications (8%). There appears to be no risk for mortality (3–208 months) (very low quality).
Economic evidence statements
The cost of artificial urinary sphincter is considerably high when the cost of the sphincter, surgery and revisional surgery is considered. This does not support the use of artificial sphincters where another option is available that is judged to be of equal efficacy such as autologous sling surgery. However where no other option is available, the gains in quality of life combined with a partially offset cost of incontinence aids may make this intervention cost effective compared to other treatments.
9.3.2. Recommendations and links to evidence
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| Recommendations: | ARTIFICIAL URINARY SPHINCTER
- 43.
Consider surgery to insert an artificial urinary sphincter for people with neurogenic stress incontinence only if an alternative procedure, such as insertion of an autologous fascial sling, is less likely to control incontinence. - 44.
When considering inserting an artificial urinary sphincter: discuss with the person and/or their family members and carers the risks associated with the device, the possible need for repeat operations and alternative procedures ensure that the bladder has adequate low-pressure storage capacity.
- 45.
Monitor the upper urinary tract after artificial urinary sphincter surgery (for example, using annual ultrasound scans) as bladder storage function can deteriorate in some people after treatment of their neurogenic stress incontinence.
|
|---|
| Relative value placed on the outcomes considered | The GDG recognised that a high value is placed on continence and quality of life. |
| Quality of evidence | The evidence consisted of observational studies with no comparison groups being assessed therefore the data are at high risk of bias. There is low confidence in the estimate of effect. The populations studied were largely restricted to congenital spinal disorders. There was little evidence on quality of life. Although the studies were very low quality, all studies reported that surgery was associated with improvements in continence.
The economic evidence was based on unit costs of interventions. |
| Trade-off between clinical benefits and harms | The most prominent risks found in the studies were device failure (26%), bladder neck erosion or device infection (11%), the need for revision (34%), the need for complete removal (22%), UTIs (9%) and upper tract complications (8%).
It is accepted that sphincter devices have a finite lifespan of around 10 years and therefore will require replacement at some point as a matter of routine. However, the device is capable of curing or markedly improving incontinence in the majority of patients who receive implants for neurogenic stress urinary incontinence.
Significant harm can arise if device infection or erosion occurs as revision surgery will then be essential. It is also accepted that upper tract deterioration will be seen in some patients if appropriate assessment and treatment of bladder dysfunction is not undertaken preoperatively and patient follow up is neglected. The GDG were aware of the experience of clinicians who first introduced the artificial urinary sphincter into clinical practice; the importance of the preoperative urodynamic assessment of bladder function was not appreciated at that time and upper tract deterioration was seen in some patients in whom low pressure storage capacity was lacking. The GDG agreed that preoperative assessment of the bladder to ensure low pressure storage capacity was necessary. |
| Economic considerations | The cost of artificial urinary sphincter is considerably high when the cost of the sphincter, surgery and revisional surgery is considered. This does not support the use of artificial sphincters where another option, such as autologous sling surgery, is available and is judged to be of equal efficacy. However where no other option is available, the gains in quality of life combined with partially offset costs of incontinence aids may make this intervention a cost effective compared to other treatments. |
| Other considerations | The AUS is currently established as a standard treatment for uro-dynamically-proven stress urinary incontinence in adult males with NLUTD. Its role in children and in women is less well established.
Despite the limited evidence base that was obtained from the literature review, the GDG was able to make the above recommendation on the basis of the consistent effect on continence improvement that the studies reported. This was supported by the clinical experience of GDG members. It was also noted that alternative treatment options are not necessarily available (especially in men) or reliable in reducing incontinence levels. The GDG made the recommendation while acknowledging the significant complication rates and associated need for re-operation in some patients that are associated with artificial urinary sphincter implantation. |
