Dr Susie Orme outlines the range of treatments available to women for the different types of urinary incontinence and explains why an updated NICE guideline was needed

NICE Accreditation Mark
NICE Accreditation Mark

 

NICE Clinical Guideline 171 on Urinary incontinence: the management of urinary incontinence in women has been awarded the NICE Accreditation Mark.

This Mark identifies the most robustly produced guidance available.
See evidence.nhs.uk/accreditation for further details.

A lthough urinary incontinence (UI) is not a life-threatening condition, its impact on quality of life should not be underestimated. Urinary incontinence can adversely influence a person’s perception of their physical wellbeing, as well as compromising their social and sexual functioning. In addition, the resource implications for the NHS of not treating urinary incontinence (e.g. cost of pads, increased hospital lengths of stay) are considerable.1-3

The prevalence of daily UI in women aged over 65 years is estimated to be between 4% and 17%.4

Urinary incontinence is a treatable condition and intervention is cost effective both for the individual and for the wider healthcare community.3

The need for updated guidance

The first NICE clinical guideline (CG) on the management of UI in women (NICE CG40) was published in 2006. Since then, there have been advances in the treatment of UI in women, including surgical techniques, use of botulinum toxin A, and neuromodulation for the treatment of overactive bladder (OAB), which have become more widely available on the NHS. Synthetic tape procedures are also now more commonly used in the surgical treatment of stress UI (SUI), with increasingly reported effectiveness.5

Further guidance was needed to ensure cost-effective treatment and to inform patient choice, and in September 2013, NICE CG171, Urinary incontinence: the management of urinary incontinence in women was issued. Much of the original guidance from NICE CG40 has been incorporated into NICE CG171. This article therefore focuses on changes to treatment pathways, as set out in CG171.6

NICE CG171 is available in several formats and there are links to the various resources and clinical pathways at www.nice.org.uk/CG171. A useful interactive NICE pathway, Urinary incontinence in women overview, is also available.7

Scope of the updated guidance

Women with neurological disease (for example, spinal injury, dementia, and Parkinsonism) fall outside the scope of CG171; for guidance on management of these women, see NICE CG148 on Urinary incontinence in neurological disease.8

Definitions

The definitions used in the updated clinical guideline are those of the International Continence Society (see Box 1, below).10

Box 1: Some definitions used in NICE CG1716,9

  • Stress UI is involuntary leakage of urine on exertion, sneezing, or coughing
  • Urgency UI is the involuntary leakage of urine preceded by urgency (this is a severe and compelling desire to urinate that is difficult to overcome)
  • Mixed UI is involuntary leakage associated with both urgency and exertion or sneezing or coughing. Initial treatment should focus on the most severe symptom
  • OAB is the symptom complex of urgency, urinary frequency, and nocturia; it is often associated with the urodynamic finding of detrusor instability. It can occur with UI.

UI=urinary incontinence; OAB=overactive bladder

Initial assessment and investigation

See Figure 1 for a summary of the initial advice and conservative treatments for women presenting with UI.9

Initial diagnosis and assessment of UI, a trial of conservative treatment, and initial prescription of an antimuscarinic drug can all take place within primary care. This can either be via the GP or the community continence service.

A urine dip test should be performed in all women presenting with UI. A clinical history (including review of a 3-day bladder diary), physical examination, and investigations as shown in the NICE pathway6 should be sufficient to make an initial diagnosis of SUI, urgency UI, or mixed UI, and to begin initial treatment. The initial treatment for mixed UI should be indicated by the predominant symptom.6

Measurement of post-void residual urine volume is recommended in women with symptoms suggestive of voiding dysfunction or recurrent urinary tract infections (UTI).6 Post-void residual urine volume can be measured by catheterisation or by ultrasound. Bladder scanning using ultrasound is preferable on the grounds of patient acceptability and lower incidence of adverse events.6

Urgent referral and specialist intervention

Practitioners should refer women with the following ‘red-flag’ symptoms urgently to secondary care:6

  • microscopic haematuria in women aged 50 years and older
  • visible haematuria
  • recurrent or persisting UTI associated with haematuria in women aged
    40 years and older
  • suspected malignant mass arising from the urinary tract.

For further details about urgent referral and the need for specialist intervention in women with UI, see NICE pathways on Initial assessment and investigation of UI.6

Figure 1: Initial advice and conservative treatments10*
Initial advice and conservative treatments10*

UI=urinary incontinence; OAB=overactive bladder; ICIQ=International Consultation on Incontinence Questionnaire; BFLUTS=Bristol Female Urinary Tract Symptoms (questionnaire); I-QOL=Incontinence Quality-of-Life (questionnaire); SUIQQ=Stress and Urge Incontinence Quality of Life Questionnaire; UISS= Urinary Incontinence Severity Score; ISI= Incontinence Severity Index; KHQ= King’s Health Questionnaire;
MDT=multidisciplinary team

Reproduced from: National Collaborating Centre for Women’s and Children’s Health. Urinary incontinence in women: the management of urinary incontinence. Clinical Guideline No. 171, London: RCOG, 2013, with the permission of the Royal College of Obstetricians and Gynaecologists.

*The full versions of Figures 1 and 2 can be found at www.nice.org.uk/nicemedia/live/14271/65144/65144.pdf

Conservative treatment of urinary incontinence

Conservative and behavioural therapies are effective and should form part of first-line therapy for UI:6

  • a trial of caffeine restriction is effective in OAB
  • modification of fluid intake (reduction or increase as appropriate) is effective in both OAB and SUI
  • bladder retraining in urgency UI can increase the interval between voiding episodes
  • weight reduction is recommended in women who have UI and a body mass index greater than 30 kg/m2.

Physical therapy

 

Pelvic floor muscle training

Pelvic floor muscle training is an effective therapy for SUI, and mixed UI if stress symptoms predominate, and should be regarded as first-line therapy.3 NICE CG171 recognises that such training should be properly supervised and that there is a need to ensure the woman can contract her pelvic floor correctly. The guideline recommends that digital rectal examination be performed prior to commencing a pelvic floor muscle-training programme. This should form part of the initial examination when making a clinical diagnosis.6 No timescale is given in CG171 for the duration of pelvic floor muscle training, and it can be continued if found to be beneficial.6

Trancutaneous sacral nerve stimulation and transcutaneous tibial nerve stimulation

Otherwise known as transcutaneous electrical nerve stimulation, transcutaneous sacral nerve stimulation and transcutaneous tibial nerve stimulation are ineffective in the management of OAB and should not be used.6

Percutaneous tibial nerve stimulation

Percutaneous tibial nerve stimulation is becoming more widely available and is offered in many secondary care centres as a treatment for OAB. However, there is insufficient evidence to recommend it as an effective treatment for OAB. It has a place after multidisciplinary team (MDT) review for women who do not wish to have treatments such as botulinum toxin A and sacral nerve modulation with an implantable device, both of which have been shown to be effective.6

Pharmacological treatment

Figure 2: Drug treatment for OAB and mixed UI10
Drug treatment for OAB and mixed UI OAB=overactive bladder; UI=urinary incontinence; MDT=multidisciplinary team


Reproduced from: National Collaborating Centre for Women’s and Children’s Health. Urinary incontinence in women: the management of urinary incontinence. Clinical Guideline No.171, London: RCOG, 2013, with the permission of the Royal College of Obstetricians and Gynaecologists.

Antimuscarinic drugs

As with any prescription, before offering drugs to treat OAB, practitioners should take into account the presence of co-existing medical conditions and the risk of adverse events, as well as the contribution these medications make to the total anticholinergic load.11-14

Patient adherence can be a problem with antimuscarinic drugs, as side-effects (e.g. dry mouth and constipation) tend to occur before the patient gains benefit from treatment. New to the 2013 guidance in CG171 is the recommendation that, prior to being prescribed OAB drugs, patients should be counselled about:6

  • the likelihood of success
  • common associated side-effects
  • patient choice regarding dose frequency and route of administration
  • adverse effects, some of which may indicate that the treatment is starting to have an effect, and that the full benefits may not be seen until the person has taken the treatment for
    4 weeks.

The lowest recommended dose should be prescribed when starting a new OAB drug treatment.

First-line agents

On the basis of their efficacy, and on the British National Formulary reference costs at the time of writing of NICE CG171, the following drugs are recommended as first-line agents in the treatment of OAB or mixed UI: 15

  • oxybutynin immediate release (IR)
  • tolterodine IR
  • darifenacin (taken once daily).

A transdermal agent for OAB (currently available in the UK as a patch) can be offered to those women who are unable to tolerate oral medication.6

The choice of three agents gives the prescriber and patient more choice in terms of side-effect profiles and dosing schedules. However, oxybutynin IR should not be used in frail older women. (Frailty is defined by the GDG as a woman with multiple co-morbidities, functional impairments, and any degree of cognitive impairment.)6

Second-line agents

If the first treatment for OAB or mixed UI is not effective or well-tolerated, offer another drug with the lowest acquisition cost. The second-line agents recommended by NICE all appear to have similar efficacy and tolerability. Reduction in drug costs (e.g. by local procurement negotiations) may influence the choice of second-line agents.

The evidence review for NICE CG171 considered the following second-line drugs, which will be delivered in both primary and secondary care: darifenacin, fesoterodine, oxybutynin (immediate release), oxybutynin (extended release), oxybutynin (transdermal), oxybutynin (topical gel), propiverine, propiverine (extended release), solifenacin, tolterodine (immediate release), tolterodine (extended release), trospium and trospium (extended release).6

Desmopressin

Desmopressin may be used to reduce nocturia in OAB and UI. It should be used with caution in cystic fibrosis and is contraindicated in women aged over 65 years or who have hypertension.6,15 At the time of publication of NICE CG171 (September 2013), desmopressin did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council’s Good practice in prescribing and managing medicines and devices for further information.16

Duloxetine

Duloxetine should be used only in those women with predominant SUI who decline or are not suitable for surgical intervention, and after appropriate counselling about its adverse effects.15

Mirabegron

The selective beta-3 adrenoceptor agonist, mirabegron, was not available at the time of scoping of NICE CG171 but has been the subject of a separate review in NICE Technology Appraisal 290.17 It is recommended for the treatment of symptoms of OAB in women in whom antimuscarinic drugs:17

  • are contraindicated
  • have been clinically ineffective
  • have unacceptable side-effects.

Patient review

Review of the patient at 4 weeks is now recommended (no explicit time for review was given previously in NICE CG40). Review may be performed by telephone or face-to-face interview. Medication can, however, be switched before the 4-week review if the drug side-effect profile proves intolerable to the patient.6

If treatment is found to be effective at the 4-week review but subsequently becomes suboptimal after the initial success of the drug, the practitioner should offer a further review (face to face or by telephone).6

Review is recommended annually for women in whom medication is effective (or 6-monthly if the woman is aged over 75 years).6

Although trial of a second antimuscarinic agent is recommended, women who decline a second agent, or who wish to discuss invasive therapy, should be referred to the secondary care MDT.6

Multidisciplinary teams in secondary care

With the emergence of new surgical therapies, CG171 recommends the formation of MDTs in secondary care. The presence of MDTs and clinical networks within secondary and tertiary care will ensure that all proven invasive treatments are available to all women, regardless of where they live. This will ensure uniform and high-quality care for women with UI and a smooth transition from primary to secondary, and (if required) tertiary care.6

It is envisaged by the guideline development group (as evidence of good practice) that cases will be discussed within the MDT, and that the team’s recommendations will be discussed with each woman to provide her with an informed treatment choice before she embarks on invasive therapies.

The minimum membership requirements of the MDT are:6

  • urogynaecologist
  • urologist with a sub-specialist interest in female urology
  • specialist nurse
  • specialist physiotherapist
  • colorectal surgeon with a sub-specialist interest in functional bowel problems, for women with coexisting bowel problems
  • a member of the care of the elderly team and/or occupational therapist, for women with functional impairments.

The MDT should consider each woman’s:6

  • preferences
  • future child-bearing wishes
  • past management of UI
  • co-morbidities.

Impact on primary care

Ideally, the initial assessment and diagnosis of UI in women should be carried out in primary care. The level of provision of specialist community continence services differs widely throughout the UK. Where provision is sparse, there is a potential increase in workload for GPs. There are also training needs regarding:

  • how findings on a 3-day bladder diary are helpful in identifying the cause of UI
  • professionals’ ability to recognise a woman’s capacity to perform pelvic floor contractions.

Ideally, pelvic floor muscle training should occur prior to referral into secondary care as it is an effective therapy for stress UI. However, access to specialist training of this kind within primary care is not uniform. The revised guidance regarding this in CG171 was intended to ensure women are taught how to contract their pelvic floor muscles correctly, rather than that they are simply given written information.

The requirement for review at 4 weeks after starting antimuscarinic therapy may be problematic for general practice, as more (and potentially longer) appointment times will be needed. However, the review can be carried out over the telephone, as well as in person.
As most prescriptions would cover a
28-day period, the review could coincide with the request for repeat prescriptions.

The formation of secondary care MDTs and clinical networks will ensure that GPs can refer women on as necessary, and that all proven treatment options are available to them.

Conclusion

Urinary incontinence in women is a common and distressing condition. The costs of containment methods (e.g. absorbent pads) are high; in contrast, treatment of UI is cost effective. Diagnosis can be made by way of a focused clinical history, physical examination, and simple investigations.

A trial of lifestyle and conservative therapy is appropriate before pharmacological and invasive therapy are considered.

Oxybutynin IR remains the most cost-effective antimuscarinic agent, but its side-effect profile and dosing schedule may not be acceptable to all women, so CG171 includes a choice of first-line medication.

The formation of MDT and clinical networks in secondary and tertiary care should mean quality, cost-effective, and uniform care is available to all women with UI.

 
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