Review of NICE Clinical Guidelines CG40

Elaine Clydesdale
Guidelines coordinator CG40 Review Team
National Institute for Health and Clinical Excellence
Level 1A, City Tower
Piccadilly Plaza
Manchester
M1 4BD

4 July 2011

Dear ElaineReview of CG40 – Urinary Incontinence in Women

I apologise for the late submission of comments to your scoping document. Unfortunately I only became aware of the timetable on Friday 1 July. I have now registered as a stakeholder in this review process and I hope that from now on I will be in the loop.

I have one small but very significant comment to make about the scope of the review concerning para 4.3.2.e Clinical Issues that will not be covered.

I was surprised and concerned that your review does not intend to review lifestyle interventions, physical therapies and non-therapeutic interventions.

Since the last review of these guidelines in 2006 there has been a major advance in the treatment of urinary stress incontinence (USI) in primary care that offers very significant improvements in patient outcomes and a significant reduction in cost to the NHS.

Following a lengthy clinical trial of the PelvicToner™ progressive resistance vaginal exerciser, published by Professor Marcus Drake of the Bristol Urological Institute in the British Journal of Urology International January 2010, NHS Prescription Services placed the PelvicToner on the Drug Tariff IXA and created a new category specifically for the purpose – Pelvic Toning Devices.

In the clinical trial the PelvicToner, used totally unsupervised, proved to be as effective as the current NICE best practice recommendation of Supervised Pelvic Floor Muscle Training PFMT despite the fact that it was only tested to a fraction of the manufacturer’s recommended programme.

The BJUI article noted that:

Despite widespread acceptance and support amongst clinicians for this seemingly straightforward conservative therapy, women with SUI often find PFME to be problematic. Two particular issues are:
i) Lack of confidence in successfully identifying the pelvic floor muscles
ii) Compliance issues associated with the requirement to commit to a daily regime of PFME in the longer term

In addition, provision of formal training for PFME is patchy; many women do not have access to a suitable trainer, receive no feedback as to whether they are contracting their pelvic floor, are not informed of the need for adhering to the recommended regime and are not followed up.

It was also noted that in the vast majority of cases women do not receive any supervision and are merely presented with a sheet of exercises which completely fails to achieve the desired outcome.

The BJUI paper concluded that the PelvicToner offered significant advantages over PFMT:

The [PelvicToner] aided women to identify their pelvic floor confidently. It is a safe and well tolerated adjunct to PFME, which increases patient choice and may promote subsequent compliance and sustained efficacy.

In our submission to NHS Prescription Services we were able to demonstrate that the PelvicToner was able to deliver significant cost-savings to the NHS (see below), enable scarce resources to be better focussed on those for women for whom PFMT is not wholly appropriate and for whom supervised treatment and other interventions are necessary, and help achieve a much higher level of positive outcomes for the women concerned.

Our cost benefit analysis was based on published NICE CG40 Full Guidelines even if the figures were up to 7 years out of date – see Appendix 1.

The NICE Guideline does not add a cost for primary care and therefore it was assumed that the cost of an initial GP consultation with a referral or prescription carries no cost.

The PelvicToner provided on prescription offers the equivalent benefit of supervised PFMT plus biofeedback at a cost of £15.00.

Urodynamics training is costed by NICE at £140.00

Pelvic Floor Muscle Training alone is costed at £131.00 on average and up to £168.00

Pelvic Floor Muscle Training with Biofeedback is costed at £166.00

It is the latter option that most closely equates to PelvicToner use. A cost-benefit ratio in excess of 13:1 based on 2004 figures seems to be pretty convincing.

There would obviously be a benefit in providing a PelvicToner to every woman presenting with symptoms of SUI, instead of just an exercise sheet. This would undoubtedly lead to a reduction in demand for specialist physiotherapy services and surgical intervention but that calculation must be left to the experts.

If there is any other information that you need then I am sure you will be in touch.

In the meantime I hope that I will now be part of the process of review and look forward to further contact.

Yours sincerely

Barry Fowler
Director

Solution Project Management Ltd, 86 Shirehampton Road, Bristol, BS9 2DR
T: 0117 968 01710117 968 0171 F: 0117 962 6184 E: [email protected]
Reg: 5157009 VAT: 855 4751 00

Appendix 1:

Extract from NICE CG40 Full Guidelines App E pp 161 -162

Pelvic floor muscle training

Description of treatment and assumptions
It is difficult to define a ‘standard’ or ‘typical’ PFMT session and therefore costs will vary according to the actual practices employed.
_ Costings are based on treatment being undertaken by a senior 1 grade women’s health
physiotherapist† in a hospital physiotherapy department.
_ There are a total of six sessions with the therapist.‡
_ The initial session lasts 1 hour; subsequent sessions last half an hour.
_ Consumables at the initial session include gloves, single-use KY Jelly, wipes (×2), paper
towels (×4).
_ Consumables at subsequent sessions include gloves, wipes (×2), paper towels (×4).
_ Additional consumables may include exercise diaries and advice leaflets (often provided free by companies) but these are negligible and not included.
∗ Converts a present value into an annuity, a series of equal annual payments.
† Remuneration for a continence nurse specialist grade f–g/band 6–7 is similar.
‡ Estimates from GDG members that four to eight sessions are typically offered.

Urinary incontinence
Labour costs
Contact time with patient: (1 × 1) + (5 × 0.5) = 3.5 hours
Unit cost: £37 per hour
Labour cost: £37 × 3.5 = £129.50

Consumables
Item Quantity Unit cost Cost
Gloves 6 £0.02 £0.11
KY Jelly 1 £0.80 £0.80
Couch roll 6 £0.04 £0.22
Paper towels 24 Less than £0.01 £0.07
Wipes 12 £0.03 £0.30
Total £1.50

Total cost for PFMT: £131 (£94 to £168)∗

PFMT + biofeedback

Description of treatment and assumptions
Not only is it difficult to define a ‘standard’ for PFMT but biofeedback can also take many different forms. Costs will therefore vary according to actual practice and biofeedback equipment used:
_ Number of sessions and duration is typically the same as for ‘ordinary’ PFMT. Therefore, costs of PFMT + Biofeedback have been estimated by adding the costs associated with biofeedback to PFMT alone (see above).
_ Biofeedback is undertaken using a Verity NeuroTracTM Simplex (hand-held single-channel
EMG unit), a Neen Educator_R and a Neen Periform vaginal probe.
_ It is assumed that the NeuroTrac device is loaned to patients for home use for 3 months and that it has a lifespan of 5 years (i.e. the cost of equipment is spread over 20 patients).
_ Educators and probes are for single-patient use and are treated as consumable costs.

PFMT costs: £131

Additional biofeedback costs
Consumables
Item Quantity Unit cost Cost
Neen Educator 1 £19.50 £19.50
Neen Periform 1 £10.25 £10.25
Total £29.75
∗ Range based on four to eight sessions.

Equipment
Item Cost Equivalent annual cost Cost/patient
Verity NeuroTrac Simplex £99 £19.84 £4.96

Total cost for PFMT + biofeedback: £166
Labour costs
Contact time with patient: (1 × 1) + (5 × 0.5) = 3.5 hours
Unit cost: £37 per hour
Labour cost: £37 × 3.5 = £129.50

Consumables
Item Quantity Unit cost Cost
Gloves 6 £0.02 £0.11
KY Jelly 1 £0.80 £0.80
Couch roll 6 £0.04 £0.22
Paper towels 24 Less than £0.01 £0.07
Wipes 12 £0.03 £0.30
Total £1.50

Additional biofeedback costs

Consumables
Item Quantity Unit cost Cost
Neen Educator 1 £19.50 £19.50
Neen Periform 1 £10.25 £10.25
Total £29.75
∗ Range based on four to eight sessions.

Equipment
Item Cost Equivalent annual cost Cost/patient
Verity NeuroTrac Simplex £99 £19.84 £4.96

Total cost for PFMT + biofeedback: £166

A wholly different agenda

Unfortunately these comments were in vain and NICE refused to amend the scope of the review. A further attempt was made to influence the Guidelines when the first draft was published in September 2013.

You can read our observations and the comments made by NICE if you click here

In April 2014 NICE set up a committee to review Quality Standards in the Treatment of Urinary Incontinence in Women.

You can read our submission if you click here