These guidelines are no longer actively supported or updated; the content may now be out of date.
Please refer to the NICE website for any new versions of the source guideline.
These guidelines are no longer actively supported or updated; the content may now be out of date.
Please refer to the NICE website for any new versions of the source guideline.
Published May 2016
Recommendations Tools and resources Download (.pdf)The UK’s National Institute for Health and Care Excellence (NICE) provides evidence-based guidance and advice to improve health and social care.
Clinical guidelines are recommendations by NICE on the most effective ways to diagnose, treat and care for people with specific conditions within the NHS and beyond. They are based on the best available evidence of clinical and cost effectiveness. While clinical guidelines help health professionals and others in their work, they do not replace their knowledge and skills.
Good clinical guidelines aim to improve the quality of healthcare and reduce inequalities and variation in practice. They can change the process of healthcare and improve outcomes for patients. Clinical guidelines:
The Best Practice Advocacy Centre New Zealand (bpacnz) has an agreement with NICE to contextualise recently published NICE clinical guidelines for the New Zealand health care sector. The contextualisation process is described in detail on the bpacnz website. As part of this process, bpacnz will convene a Guideline Review and Contextualisation Group (GRCG) for each guideline. The GRCG will carefully consider the NICE guideline recommendations, taking into account the differences between the UK and New Zealand health care systems to produce a guideline that is relevant to those delivering and managing care in New Zealand.
Urinary incontinence (UI) is a common symptom that can affect women of all ages, with a wide range of severity and nature. While rarely life-threatening, incontinence may seriously influence the physical, psychological and social wellbeing of affected individuals. The impact on the families and carers of women with UI may be profound, and the resource implications for the health service considerable.
UI is defined by the International Continence Society as ‘the complaint of any involuntary leakage of urine’. UI may occur as a result of a number of abnormalities of function of the lower urinary tract or as a result of other illnesses, which tend to cause leakage in different situations.
Urinary incontinence in neurological disease is outside the scope of this guideline but is covered in the NICE clinical guideline 148 – Urinary incontinence in neurological disease. This guideline has not been contextualised for New Zealand.
The guideline will assume that prescribers will use a medicine according to the New Zealand marketing authorisation (Medsafe) and the relevant sections of the New Zealand Medicines Act (1981).
This guideline offers best practice advice on the care of women with urinary incontinence.
Patients and healthcare professionals have rights and responsibilities as set out by the New Zealand Code of Health and Disability Services Consumers’ Rights. This contextualised guideline is written to reflect these rights.
Treatment and care should take into account individual needs and preferences. Patients should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals.
The Code of Health and Disability Services Consumers’ Rights states that patients have rights as consumers of health and disability services provided by doctors and other health professionals in public and private services, for paid and unpaid services, within hospitals and within private practices. The code of rights is law under the Health and Disability Act 1994 (the HDC Act).
The following recommendations have been identified by the GRCG as priorities for implementation.
If this is not effective or well-tolerated offer another option of tolterodine or solifenacin (subsidised with Special Authority approval).
The following guidance is based on the best available evidence. The NICE full guideline (CG171) 1 gives details of the methods and the evidence used to develop the NICE guidance. The process and methods for contextualising the NICE guideline for the New Zealand health sector is available here 2
The wording used in the recommendations in this guideline (for example words such as ‘offer’ and ‘consider’) denotes the certainty with which the recommendation is made (the strength of the recommendation). See the ‘Strength of recommendations’ section in this guideline.
During any clinical assessment or management the clinician should be respectful of a patient’s cultural and ethnic background, specifically acknowledging that for Māori and Pacific peoples all bodily waste (urine, menstrual blood, faeces) can be considered tapu. It is important to keep things that are tapu, or restricted, separate from things that are noa, or unrestricted. In many cases, these concepts align with good health and safety practice.
At the initial clinical assessment, categorise the woman’s urinary incontinence (UI) as stress UI (SUI), mixed UI, or urgency UI/overactive bladder (OAB). Start initial treatment on this basis. In mixed UI, direct treatment towards the predominant symptom.
If stress incontinence is the predominant symptom in mixed UI, discuss with the woman the benefit of conservative management including OAB medicines before offering surgery.
During the clinical assessment seek to identify relevant predisposing and precipitating factors and other diagnoses that may require referral for additional investigation and treatment.
Undertake routine digital assessment to confirm pelvic floor muscle contraction before the use of supervised pelvic floor muscle training for the treatment of UI.
Refer women with UI who have symptomatic prolapse that is visible at or below the vaginal introitus to a specialist.
Undertake a urine dipstick test in all women presenting with UI to detect the presence of blood, glucose, protein, leucocytes and nitrites in the urine.
If women have symptoms of urinary tract infection (UTI) and their urine tests positive for both leucocytes and nitrites send a midstream urine specimen for culture and analysis of antibiotic sensitivities. Prescribe an appropriate course of antibiotic treatment pending culture results.
If women have symptoms of UTI and their urine tests negative for either leucocytes or nitrites send a midstream urine specimen for culture and analysis of antibiotic sensitivities. Consider the prescription of antibiotics pending culture results.
If women do not have symptoms of UTI, but their urine tests positive for both leucocytes and nitrites, do not offer antibiotics without the results of midstream urine culture.
If a woman does not have symptoms of UTI and her urine tests negative for either leucocytes or nitrites do not send a urine sample for culture because she is unlikely to have UTI.
Measure post-void residual volume by bladder scan or catheterisation in women with symptoms suggestive of voiding dysfunction or recurrent UTI.
Use a bladder scan in preference to catheterisation on the grounds of acceptability and lower incidence of adverse events.
Refer women who are found to have a palpable bladder on bimanual or abdominal examination after voiding to a specialist.
Urgently refer women with UI who have suspected malignant mass arising from the urinary tract.
Haematuria (macroscopic and microscopic) should be investigated urgently and referred according to local referral pathways.
In women with UI, further indications for consideration for referral to a specialist service include:
Use the following incontinence-specific quality-of-life scales when therapies are being evaluated: ICIQ, BFLUTS, I-QOL, SUIQQ, UISS, SEAPI-QMM, ISI and KHQ.4
Use bladder diaries in the initial assessment of women with UI or OAB. Encourage women to complete a minimum of 3 days of the diary covering variations in their usual activities, such as both working and leisure days.
Do not use pad tests in the routine assessment of women with UI.
Do not perform multi-channel cystometry or videourodynamics before starting conservative management.
After undertaking a detailed clinical history and examination, perform multi-channel filling and voiding cystometry before surgery in women who have:
Do not perform multi-channel filling and voiding cystometry in the small group of women where pure SUI is diagnosed based on a detailed clinical history and examination.
Consider videourodynamics if the diagnosis is unclear after multi-channel cystometry.
Do not use the Q-tip, Bonney, Marshall and Fluid-Bridge tests in the assessment of women with UI.
Do not use cystoscopy in the initial assessment of women with UI alone.
Do not use imaging (MRI, CT, X ray) for the routine assessment of women with UI. Do not use ultrasound other than for the assessment of residual urine volume.
Recommend a trial of caffeine reduction to women with OAB.
Consider advising modification of high or low fluid intake in women with UI or OAB.
Advise women with UI or OAB who have a BMI greater than 30 to lose weight.
Offer a trial of supervised pelvic floor muscle training of at least 3 months duration as first-line treatment to women with stress or mixed UI.
Pelvic floor muscle training programmes should comprise at least 8 contractions performed 3 times per day.
Do not use perineometry or pelvic floor electromyography as biofeedback as a routine part of pelvic floor muscle training.
Continue an exercise programme if pelvic floor muscle training is beneficial.
Do not routinely use electrical stimulation in the treatment of women with OAB.
Do not routinely use electrical stimulation in combination with pelvic floor muscle training.
Electrical stimulation and/or biofeedback should be considered in women who cannot actively contract pelvic floor muscles in order to aid motivation and adherence to therapy.
Offer bladder training lasting for a minimum of 6 weeks as first-line treatment to women with urgency or mixed UI.
If women do not achieve satisfactory benefit from bladder training programmes or, in the case of some elderly women, anticipated to not achieve satisfactory benefit due to poor adherence to bladder training or pelvic floor muscle training, the combination of an OAB medicine with bladder training should be considered if frequency and urge UI are troublesome symptoms.
Do not offer transcutaneous sacral nerve stimulation to treat OAB in women.
Explain that there is insufficient evidence to recommend the use of transcutaneous posterior tibial nerve stimulation to treat OAB.
Do not offer transcutaneous posterior tibial nerve stimulation for OAB.
Do not offer percutaneous posterior tibial nerve stimulation for OAB unless:
Explain that there is insufficient evidence to recommend the use of percutaneous posterior tibial nerve stimulation to routinely treat OAB.
Absorbent products,6 hand held urinals and toileting aids should not be considered as a treatment for UI. Use them only as:
Bladder catheterisation (intermittent or indwelling urethral or suprapubic) should be considered for women in whom persistent urinary retention is causing incontinence, symptomatic infections, or renal dysfunction, and in whom this cannot otherwise be corrected. Healthcare professionals should be aware, and explain to women, that the use of indwelling catheters in urgency UI may not result in continence.
Offer intermittent urethral catheterisation to women with urinary retention who can be taught to self-catheterise or who have a carer who can perform the technique.
Give careful consideration to the impact of long-term indwelling urethral catheterisation. Discuss the practicalities, benefits and risks with the patient or, if appropriate, her carer. Indications for the use of long-term indwelling urethral catheters for women with UI include:
Indwelling suprapubic catheters should be considered as an alternative to long-term urethral catheters. Be aware, and explain to women, that they may be associated with lower rates of symptomatic UTI, ‘bypassing’, and urethral complications than indwelling urethral catheters.
Do not use intravaginal and intraurethral devices for the routine management of UI in women. Do not advise women to consider such devices other than for occasional use when necessary to prevent leakage, for example during physical exercise.
Do not recommend complementary therapies for the treatment of UI or OAB.
Offer pelvic floor muscle training to women in their first pregnancy as a preventive strategy for UI.
If a woman chooses not to have further treatment for urinary incontinence:
When offering antimuscarinic medicines to treat OAB always take account of:
Before OAB medicine treatment starts, discuss with women:
Prescribe the lowest recommended dose when starting a new OAB medicine treatment.
If a woman’s OAB medicine treatment is effective and well-tolerated, do not change the dose or medicine.
Offer oxybutynin (immediate release) to women with OAB or mixed UI
Consider oxybutynin (immediate release) with caution for frail older women.7
If oxybutynin (immediate release) is not effective or well-tolerated, offer tolterodine or solifenacin (subsidised with Special Authority approval).
Transdermal oxybutynin or other transdermal OAB medicines can be offered to women unable to tolerate oral medication but are not currently subsidised in New Zealand.
Mirabegron is classified as a prescription medicine in New Zealand but there are currently no medicines containing mirabegron registered for use in New Zealand. For guidance on mirabegron for treating symptoms of overactive bladder, refer to Mirabegron for treating symptoms of overactive bladder (NICE technology appraisal guidance 290).8
Do not use propantheline, imipramine (or other tricyclic antidepressants) or flavoxate9 for the treatment of UI or OAB in women.
Offer oxybutynin (immediate release) to women with OAB or mixed UI medicine treatment. Ask the woman if she is satisfied with the therapy:
Offer review before 4 weeks if the adverse events of OAB medicine treatment are intolerable.
Offer referral to secondary care if the woman does not want to try another medicine, but would like to consider further treatment.
Offer a further face-to-face or telephone review if a woman’s condition stops responding optimally to treatment after an initial successful 4-week review.
Review women who remain on long-term medicine treatment for UI or OAB annually in primary care.
Offer referral to secondary care if OAB medicine treatment is not successful.
If the woman wishes to discuss the options for further management (non-therapeutic interventions and invasive therapy) refer to secondary care for urodynamic investigation to determine whether detrusor overactivity is present and responsible for her OAB symptoms and subsequent MDT review:
The use of desmopressin may be considered specifically to reduce nocturia10 in women with UI or OAB who find it a troublesome symptom. Use particular caution in women with cystic fibrosis and avoid in those over 65 years with cardiovascular disease or hypertension.
Do not use duloxetine11 as a first-line treatment for women with predominant stress UI. Do not routinely offer duloxetine as a second-line treatment for women with stress UI, although it may be offered as second-line therapy if women prefer pharmacological to surgical treatment or are not suitable for surgical treatment. If duloxetine is prescribed, counsel women about its adverse effects.
Do not offer systemic hormone replacement therapy for the treatment of UI.
Offer intravaginal oestrogens for the treatment of OAB symptoms in postmenopausal women with vaginal atrophy.
Inform any woman wishing to consider surgical treatment for UI about:
Include consideration of the woman’s child-bearing wishes in the counselling.
Offer invasive therapy (beyond botulinum toxin type A) for OAB and/or recurrent post surgical and complex cases of SUI symptoms only after an MDT review.
When recommending optimal management the MDT should take into account:
The MDT for urinary incontinence should include (if available):
Inform the woman of the outcome of the MDT review if it alters the provisional treatment plan.
All MDTs should work within an established regional clinical network, and be funded to ensure all women are offered the appropriate treatment options and high quality care.
Offer bladder wall injection with botulinum toxin type A to women with OAB caused by proven detrusor overactivity that has not responded to conservative management (including OAB medicine therapy).
Discuss the risks and benefits of treatment with botulinum toxin type A with women before seeking informed consent, covering:
Discuss the risks and benefits of treatment with botulinum toxin type A with women before seeking informed consent, covering:
Start treatment with botulinum toxin type A only if women have been assessed and are able and willing to perform clean intermittent catheterisation on a regular basis for as long as needed.
Use 100 units when offering botulinum toxin type A.
Consider a higher dose of botulinum toxin type A if 100 units has not been effective.
If botulinum toxin type A treatment has no effect discuss with the MDT.
If botulinum toxin type A treatment is effective, offer follow-up at 6 months or sooner if symptoms return for repeat treatment without an MDT referral.
Tell women how to self-refer for prompt specialist review if symptoms return following a botulinum toxin type A procedure. Offer repeat treatment as necessary.
Do not offer botulinum toxin type B to women with proven detrusor overactivity.
Offer percutaneous sacral nerve stimulation to women after MDT review if:
Consider percutaneous sacral nerve stimulation after MDT review if a woman’s OAB has not responded to conservative management (including medicines) and botulinum toxin type A.
Discuss the long-term implications of percutaneous sacral nerve stimulation with women including:
Tell women how to self-refer for prompt specialist review if symptoms return following a percutaneous sacral nerve stimulation procedure.
Restrict augmentation cystoplasty for the management of idiopathic detrusor overactivity to women whose condition has not responded to conservative management and who are willing and able to self-catheterise. Preoperative counselling for the woman or her carer should include common and serious complications: bowel disturbance, metabolic acidosis, mucus production and/or retention in the bladder, UTI and urinary retention. Discuss the small risk of malignancy occurring in the augmented bladder. Provide life-long follow-up.
Urinary diversion should be considered for a woman with OAB only when conservative management has failed, and if botulinum toxin type A, percutaneous sacral nerve stimulation and augmentation cystoplasty are not appropriate or are unacceptable to her. Provide life-long follow-up.
In New Zealand, ranking patients for elective publicly funded surgical procedures for incontinence, and other gynaecology conditions, uses Clinical Priority Access Criteria (CPAC).12 These criteria are based on a combination of:
The threshold CPAC score for surgery varies between DHBs throughout New Zealand. It is recommended that this be urgently addressed to ensure equitable access for surgery for all women in New Zealand, irrespective of their domicile.
When offering a surgical procedure discuss with the woman the risks and benefits of the different treatment options for SUI using the information (in the table ‘Information to facilitate discussion of risks and benefits of treatments for women with stress urinary incontinence’).
1.10.3 If conservative management for SUI has failed, offer:
When offering a synthetic mid-urethral tape procedure, surgeons should:
If women are offered a procedure involving the transobturator approach, make them aware of the lack of long-term outcome data.
Refer women to an alternative surgeon if their chosen procedure is not available from the consulting surgeon.
Use ‘top-down’ retropubic tape approach only as part of a clinical trial.
Refer to ‘single-incision sub-urethral short tape insertion for stress urinary incontinence’ (NICE interventional procedure guidance 262)14 for guidance on single-incision procedures.
Offer a follow-up appointment (including vaginal examination to exclude erosion) within 6 months to all women who have had continence surgery.
Do not offer laparoscopic colposuspension as a routine procedure for the treatment of stress UI in women. Only an experienced laparoscopic surgeon working in an MDT with expertise in the assessment and treatment of UI should perform the procedure.
Do not offer anterior colporrhaphy, needle suspensions, paravaginal defect repair and the Marshall–Marchetti–Krantz procedure for the treatment of stress UI.
Consider intramural bulking agents15 (silicone, carbon-coated zirconium beads or hyaluronic acid/dextran copolymer) for the management of stress UI if conservative management has failed. Women should be made aware that:
Do not offer autologous fat and polytetrafluoroethylene as intramural bulking agents for the treatment of stress UI.
In view of the associated morbidity, the use of an artificial urinary sphincter should be considered for the management of stress UI in women only if previous surgery has failed. Life-long follow-up is recommended.
Women whose primary surgical procedure for SUI has failed (including women whose symptoms have returned) should be:
Surgery and invasive procedures for UI should be undertaken only by surgeons who have received appropriate training in the management of UI and associated disorders or who work within an MDT with this training, and who regularly carry out surgery for UI in women.
Training should be sufficient to develop the knowledge and generic skills documented below. Knowledge should include the:
Generic skills should include:
Training should include competence in cystourethroscopy.
Operative competence of surgeons undertaking surgical procedures to treat UI or OAB in women should be formally assessed by trainers through a structured process.
Surgeons who are already carrying out procedures for UI should be able to demonstrate that their training, experience and current practice equates to the standards laid out for newly trained surgeons.
Only surgeons who carry out a sufficient case load to maintain their skills should undertake surgery for UI or OAB in women. An annual workload of at least 20 cases of each primary procedure for stress UI is recommended. For appropriately trained surgeons, in regional centres in particular, a lesser number of procedures may be acceptable, provided there are documented good clinical surgical outcomes. Surgeons undertaking fewer than 5 cases of any procedure annually should do so only with the support of their Clinical Director; otherwise referral pathways should be in place.
There should be a nominated clinical lead within each surgical unit with responsibility for continence and prolapse surgery. The clinical lead should work within the context of an integrated continence service.
A national audit of continence surgery should be undertaken.
Surgeons undertaking continence surgery should maintain careful audit data and submit their outcomes to registries such as the Urogynaecological Society of Australasia (UGSA) pelvic floor database or the Urological Society of Australia and New Zealand (USANZ) sling database.
Risks and benefits up to 1 year |
Risks and benefits after 1 year |
|||||||
|---|---|---|---|---|---|---|---|---|
Procedure |
Continent <1 year |
Perioperative events – tissue injury* |
Continent >1 year |
Erosion |
Retention |
Voiding dysfunction |
De novo overactive bladder symptoms |
|
Retropubic ‘bottom-up’ |
67% to 90% (24 studies) |
3% to 6% (29 studies) |
2 years |
74% to 95% (7 studies) |
0% to 4% (4 studies) |
0% to 13% 4 studies) |
18% 1 study) |
0% to 25% (4 studies) |
3 years |
81% to 92% (5 studies) |
0% (2 studies) |
0% (1 study) |
No studies |
0% to 23% (2 studies) |
|||
5 years |
69 to 85% (4 studies) |
0% to 1% (4 studies) |
0% to 5% (2 studies) |
0% to 1% (1 study) |
0% to 18% (3 studies) |
|||
7 years |
70% to 85% (2 studies) |
0% to 1% (2 studies) |
No studies |
No studies |
17% (1 study) |
|||
10 years |
56% to 85% (2 studies) |
No studies |
No studies |
No studies |
17% (1 study) |
|||
Trans-obturator ‘outside-in’ |
60% to 75% (10 studies) |
3% to 12% (14 studies) |
2 years |
80% (1 study) |
0% (1 study) |
4% (1 study) |
No studies |
7% (1 study) |
3 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
5 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
7 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
10 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
Trans-obturator ‘inside-out’ |
62% to 73% (19 studies) |
1% to 3% (14 studies) |
2 years |
87% (1 study) |
No studies |
No studies |
No studies |
No studies |
3 years |
75% to 84% (2 studies) |
1% (1 study) |
No studies |
No studies |
No studies |
|||
5 years |
69% to 89% (2 studies |
1% (2 studies) |
No studies |
No studies |
0% (1 study) |
|||
7 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
10 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
Retropubic ‘top down’ |
81% (2 studies) |
3% to 7% (3 studies) |
2 years |
No studies |
No studies |
No studies |
No studies |
No studies |
3 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
5 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
7 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
10 years |
No studies |
No studies |
No studies |
No studies |
No studies |
|||
Open colpo-suspension |
53% to 94% (10 studies) |
0% to 11% (6 studies) |
2 years |
70% to 86% (3 studies) |
No studies |
9% (1 study) |
No studies |
14% (1 study) |
3 years |
89% (1 study) |
No studies |
No studies |
No studies |
No studies |
|||
5 years |
78% to 79% (2 studies) |
No studies |
No studies |
4% (1 study) |
25% (1 study) |
|||
Autologous rectus fascial sling |
93% (1 study) |
No studies |
5 years |
No studies |
3% (1 study) |
No studies |
No studies |
16% (1 study) |
* Tissue injury includes bladder perforation, vaginal wall perforation, urethral and bladder injury.
The Guideline Review and Contextualisation Group have recommended the following New Zealand-specific research priorities.
A detailed prevalence study in New Zealand of UI and other symptoms of pelvic floor dysfunction (PFD), such as faecal incontinence and pelvic organ prolapse related to ethnicity and uptake of continence services is a high priority.
There is an urgent need of a National Register and Audit of surgery and invasive procedures for UI and other types of PFD, in particular pelvic organ prolapse.
There is also a need of an audit of pelvic floor muscle and bladder retraining, both related to assessment (and in particular vaginal examination to assess voluntary pelvic floor muscle contractility and use of urinary diaries) and outcome of conservative treatment.
This bpacnz contextualised version of a NICE clinical guideline has been developed in accordance with a scope that defines what the guideline will and will not cover.
NICE commissioned the National Collaborating Centre for Women’s and Children’s Health to develop the NICE guideline. The Centre established a Guideline Development Group (see Section 4.2), which reviewed the evidence and developed the recommendations.
The methods and processes for developing NICE clinical guidelines are described in ‘Developing NICE guidelines: the manual’. See www.nice.org.uk/article/pmg20
Further information on NICE Pathways for UI is available on the NICE website.
See: pathways.nice.org.uk/pathways/urinary-incontinence-in-women
The GRCG was composed of relevant healthcare professionals and bpacnz staff.
Don Wilson |
Emeritus Professor of Obstetrics and Gynaecology, University of Otago, Consultant Urogynaecologist, Dunedin |
Mark Weatherall |
Consultant Geriatrician and President of the New Zealand Continence Association, Wellington |
Tim Dawson |
Consultant Urogynaecologist, Auckland |
Lynn McBain |
GP, Wellington |
Sharon English |
Consultant Urologist, Christchurch (Involved from first draft of guideline to publication) |
Lucy Keedle |
Continence Nurse Advisor, Palmerston North |
Sharon Wilson |
Physiotherapist (Pelvic, Women’s and Men’s Health), Nelson |
Nigel Thompson |
GP and Clinical Lead, Best Practice Advocacy Centre |
Jared Graham |
Project Manager, Best Practice Advocacy Centre |
Tony Smith (Chair) |
Consultant Urogynaecologist, Saint Mary’s Hospital, Manchester |
Paul Abrams |
Consultant Urological Surgeon, Southmead Hospital, Bristol |
Elisabeth Adams |
Consultant Urogynaecologist, Liverpool Women’s Hospital |
Kate Anders |
Senior Nurse, King’s College Hospital, London |
Rosie Benneyworth |
GP, Taunton, Somerset |
Stephanie Knight |
Principal Physiotherapist, Airedale General Hospital, Keighley |
Cath Linney |
Patient member |
Susie Orme |
Geriatrician, Barnsley Hospital NHS Trusts |
June Rogers |
Patient member, PromoCon |
Amanda Wells |
Continence Advisor |
The NICE guideline contextualisation quality assurance team was responsible for quality assuring the guideline contextualisation process.
Phil Alderson |
Clinical Adviser, NICE Centre for Clinical Practice |
Christine Carson |
Programme Director, NICE Centre for Clinical Practice |
Andrew Gyton |
Programme Manager, NICE Centre for Clinical Practice |
Nichole Taske |
Associate Director (Methodology), NICE Centre for Clinical Practice |
This bpacnz contextualised version of a NICE clinical guideline provides recommendations about the treatment and care of people with specific diseases and conditions in New Zealand.
NICE guidelines are developed in accordance with a scope that defines what the guideline will and will not cover. The bpacnz scope outlines what the contextualised guideline will and will not cover.
This guideline was originally developed by the National Collaborating Centre for Women’s and Children’s Health in the United Kingdom, which is based at the Royal College of Obstetricians and Gynaecologists. The Collaborating Centre worked with a Guideline Development Group, comprising healthcare professionals (including consultants, GPs and nurses), patients and carers, and technical staff, which reviewed the evidence and drafted the recommendations. The recommendations were finalised after public consultation within the UK.
The methods and processes for the bpacnz contextualisation of NICE clinical guidelines are described on the bpacnz website. The NICE guideline was developed using the process described in ‘Developing NICE guidelines: the manual’. See www.nice.org.uk/article/pmg20
The guideline bpacnz have contextualised was an updated guideline which replaced NICE clinical guideline 40 (published October 2006).
Recommendations listed in the table below are those which changes have been made to the NICE clinical guideline to ensure they are appropriate for New Zealand.
| Original recommendation from Urinary Incontinence: The management of urinary incontinence in women (CG171) | Recommendation following contextualisation for this guideline | Rationale for contextualisation |
|---|---|---|
1.6.4 Refer people using a suspected cancer pathway referral (for an appointment within 2 weeks) for bladder cancer if they are:
|
1.1.15 Urgently refer women with UI who have suspected malignant mass arising from the urinary tract. Haematuria (macroscopic and microscopic) should be investigated urgently and referred according to local referral pathways |
This recommendation has been revised following high stakeholder concern at proposed wording based on the NICE Guideline ‘Suspected cancer: recognition and referral’ guideline (NG12; 2015). The GRCG has revised this recommendation to address the stakeholder comments received during consultation, and to reflect that local health pathway organisations, and DHBs, have existing health pathways in use throughout the country. Haematuria requires urgent investigation. Local pathways define the age restrictions and criteria for urgent referral for haematuria. ‘Recurrent or persisting UTI’ moved to 1.1.16 |
1.1.19 Do not perform multi-channel cystometry, ambulatory urodynamics or videourodynamics before starting conservative management. |
1.1.20 Do not perform multi-channel cystometry or videourodynamics before starting conservative management. |
Ambulatory urodynamics is not performed in New Zealand, nor do the GRCG consider future use will be considered. |
1.1.22 Consider ambulatory urodynamics or videourodynamics if the diagnosis is unclear after conventional urodynamics. |
1.1.23 Consider videourodynamics if the diagnosis is unclear after multi-channel cystometry. |
In New Zealand, ‘conventional’ urodynamics is multi-channel cystometry, and so clarity is needed here to avoid confusion highlighted by stakeholder comments. Removal of Ambulatory urodynamics made as noted above. |
1.4.2 If women do not achieve satisfactory benefit from bladder training programmes, the combination of an OAB drug with bladder training should be considered if frequency is a troublesome symptom. |
1.4.2 If women do not achieve satisfactory benefit from bladder training programmes or, in the case of some elderly women anticipated to not achieve satisfactory benefit due to poor adherence to bladder training or pelvic floor muscle training, the combination of an OAB medicine with bladder training should be considered if frequency and urge UI are troublesome symptoms. |
In NZ pay-per-service is a limiting factor, particularly in lower socioeconomic areas. The GRCG has acknowledged that a clinician may choose to initiate treatment with a combination of bladder training and OAB medicines in New Zealand to reduce cost to the patient. |
1.7.5 Do not use flavoxate, propantheline and imipramine for the treatment of UI or OAB in women. |
1.7.10 Do not use propantheline, imipramine (or other tricyclic antidepressants) or flavoxate for the treatment of UI or OAB in women. |
The GRCG felt prescribers were likely to consider other tricyclic antidepressants as these are able to be prescribed without restriction (although typically outside their marketing authorisation) in New Zealand and are subsidised , whereas the two alternative anticholinergic agents need special authority application, and other anticholinergic agents either do not have marketing authorisation or are not subsidised. Following stakeholder comments it was also agreed that the order of recommendations would best read from what was to be offered to what was not to be offered. |
1.7.7 Offer one of the following choices first to women with OAB or mixed UI:
|
1.7.5 Offer oxybutynin (immediate release) to women with OAB or mixed UI. |
In New Zealand tolterodine is only subsidised under special authority (otherwise the patient pays) if there is a ‘documented intolerance of, or is non-responsive to oxybutynin’. Darifenacin does not have marketing authorisation in New Zealand and would have to be imported by a prescriber, and it would not be subsidised. |
1.7.6 Do not offer oxybutynin (immediate release) to frail older women. |
1.7.6 Consider oxybutynin with caution to frail older women. |
See 1.7.9 below. |
1.7.8 If the first treatment for OAB or mixed UI is not effective or well-tolerated, offer another drug with the lowest acquisition cost . |
1.7.7 If oxybutynin (immediate release) is not effective or well-tolerated, offer tolterodine or solifenacin (subsidised with Special Authority approval). |
In New Zealand second-line agents (tolerodine and solifenacin) are available only on Special Authority (SA) if there is a ‘documented intolerance of, or a patient is non-responsive to oxybutynin’ |
1.7.9 Offer a transdermal OAB drug to women unable to tolerate oral medication |
1.7.8 Transdermal oxybutynin or other transdermal OAB medicines can be offered to women unable to tolerate oral medication but are not currently subsidised in New Zealand. |
In New Zealand second-line agents (tolerodine and solifenacin) are available only on Special Authority (SA) if there is a ‘documented intolerance of, or a patient is non-responsive to oxybutynin’ |
1.7.10 For guidance on mirabegron for treating symptoms of overactive bladder, refer to Mirabegron for treating symptoms of overactive bladder (NICE technology appraisal guidance 290 |
1.7.9 Mirabegron is classified as a prescription medicine in New Zealand but there are currently no medicines containing mirabegron registered for use in New Zealand. For guidance on mirabegron for treating symptoms of overactive bladder, refer to Mirabegron for treating symptoms of overactive bladder (NICE technology appraisal guidance 290). |
Contextual difference as there are currently no medicines containing mirabegron registered in New Zealand. |
1.7.15 Review women who remain on long-term drug treatment for UI or OAB annually in primary care (or every 6 months for women over 75). |
1.7.15 Review women who remain on long-term drug medicine treatment for UI or OAB annually in primary care |
There is no contract with primary care practitioners to provide any form of regular review for patients of any age in New Zealand. Primary care in New Zealand is subsidised but is fee for service, so that recommendations for regular review will incur costs to the patient. |
1.7.17 If the woman wishes to discuss the options for further management (non-therapeutic interventions and invasive therapy) refer to the MDT and arrange urodynamic investigation to determine whether detrusor overactivity is present and responsible for her OAB symptoms:
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1.7.17 If the woman wishes to discuss the options for further management (non-therapeutic interventions and invasive therapy) refer to secondary care for urodynamic investigation to determine whether detrusor overactivity is present and responsible for her OAB symptoms and subsequent MDT review:
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This reflects the different model of service and the current pathway used in New Zealand , and the role of the MDT [see 1.8.2] Not all regions will have MDT involvement as the continence service tends to be a stand-alone service. |
1.8.2 Offer invasive therapy for OAB and/or SUI symptoms only after an MDT review |
1.8.2 Offer invasive therapy (beyond botulinum toxin type A) for OAB and/or recurrent post surgical and complex cases of SUI only after an MDT review. |
The GRCG considers that the use of botulinum toxin A for treatment of OAB, and the management of primary SUI is covered by local health pathways within New Zealand. The NICE GDG concluded that there was a requirement for the treatment plan to be validated by a group of qualified healthcare professionals who have not contributed to the prior treatment of the woman. Factors within New Zealand dictate that this requirement is not practical across all regions. This approach has been strongly supported through stakeholder comments received during consultation. |
1.8.4 The MDT for urinary incontinence should include:
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1.8.4 The MDT for urinary incontinence should include (if available):
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This section must reflect the limited availability of each listed member. New Zealand has limited availability and the insertion of ‘if available’ to the recommendation has been made to reflect the New Zealand health system. Physiotherapist wording has been amended to reflect that at the time of publication the New Zealand Physiotherapy Board was developing a 3 tiered system of speciality. The highest tier had been established and a physiotherapist gaining this title can be called a ‘Specialist pelvic floor Physiotherapist.’ Other physiotherapists’ can use the title ‘Physiotherapist with special interest in pelvic floor health’. Both titles recognise training and expertise in treating urinary incontinence. The term ‘continence’ was inserted as within New Zealand a ‘specialist nurse’ may not have any training in continence. |
1.8.6 All MDTs should work within an established regional clinical network to ensure all women are offered the appropriate treatment options and high quality care. |
1.8.6 All MDTs should work within an established regional clinical network and be funded to ensure all women are offered the appropriate treatment options and high quality care |
This is to ensure that DHB’s value this exercise and include attendance at MDT’s in job descriptions for staff |
1.9.1 After an MDT review, offer bladder wall injection with botulinum toxin A to women with OAB caused by proven detrusor overactivity that has not responded to conservative management (including OAB medicine therapy). |
1.9.1 Offer bladder wall injection with botulinum toxin type A to women with OAB caused by proven detrusor overactivity that has not responded to conservative management (including OAB medicine therapy). |
The GRCG considers the use of botulinum toxin A for treatment of OAB, and the management of primary SUI is covered by local pathways within New Zealand. The NICE GDG concluded that there was a requirement for the treatment plan to be validated by a group of qualified healthcare professionals who had not contributed to the prior treatment of the woman. The GRCG involved in the contextualised guideline agreed that resource constraints regarding training for ISC in most centres in New Zealand meant the requirement for every case requiring botulinum toxin type A to be discussed at the MDT, or for explicit training in ISC prior to the use of botulinum toxin type A was not practical. The assessment of patients for use of botulinum toxin type A following local pathways was noted to work well and safely. This approach has been strongly supported through stakeholder comments received during consultation. |
1.9.3 Start treatment with botulinum toxin A only if women:
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1.9.3 Start treatment with botulinum toxin type A only if women have been assessed and are able and willing to perform clean intermittent catheterisation on a regular basis for as long as needed |
Please see above comments |
1.9.4 Use 200 units when offering botulinum toxin A |
1.9.4 Use 100 units when offering botulinum toxin type A |
In New Zealand the 100 units is the Medafe recommended dose With sensitivity to New Zealand’s health funding, the initial 100 units, followed by the 200 units is reflected in this guideline. |
1.9.5 Consider 100 units of botulinum toxin A for women who would prefer a dose with a lower chance of catheterisation and accept a reduced chance of success. |
1.9.5 Consider a higher dose if 100 units has not been effective. |
Please see above comments |
1.9.6 If the first botulinum toxin type A treatment has no effect discuss with the MDT |
1.9.6 If botulinum toxin type A treatment has no effect discuss with the MDT. |
This reflects the lower initial starting dose used within New Zealand. |
Insertion of recommendation (under 1.10.1) |
1.10.1 In New Zealand, ranking patients for elective publicly funded surgical procedures for incontinence, and other gynaecology conditions, uses Clinical Priority Access Criteria (CPAC). These criteria are based on a combination of:
The threshold CPAC score for surgery varies between DHBs throughout New Zealand. It is recommended that this be urgently addressed to ensure equitable access for surgery for all women in New Zealand, irrespective of their domicile. |
GRCG inserted recommendation to address the ‘post-code lottery’ due to variation across DHBs in New Zealand |
1.11.1 Surgery for UI should be undertaken only by surgeons who have received appropriate training in the management of UI and associated disorders or who work within an MDT with this training, and who regularly carry out surgery for UI in women. |
1.11.1 Surgery and invasive procedures for UI should be undertaken only by surgeons who have received appropriate training in the management of UI and associated disorders or who work within an MDT with this training, and who regularly carry out surgery for UI in women. |
This refers to invasive procedures for UI due to OAB and in particular the use of botulinum toxin type A i.e. should only be undertaken by appropriately trained surgeons in New Zealand as well as other surgical procedures. |
1.11.6 Only surgeons who carry out a sufficient case load to maintain their skills should undertake surgery for UI or OAB in women. An annual workload of at least 20 cases of each primary procedure for stress UI is recommended. Surgeons undertaking fewer than 5 cases of any procedure annually should do so only with the support of their clinical governance committee; otherwise referral pathways should be in place within clinical networks |
1.11.6 Only surgeons who carry out a sufficient case load to maintain their skills should undertake surgery for UI or OAB in women. An annual workload of at least 20 cases of each primary procedure for stress UI is recommended. Surgeons undertaking fewer than 5 cases of any procedure annually should do so only with the support of their clinical governance committee; otherwise referral pathways should be in place within clinical networks |
There is little robust evidence related to numbers of procedures annually [after appropriate training]. This is addressed well in the NICE full guideline (10.3 Maintaining and measuring expertise and standards for practice, p297). Mention is made of a survey in the UK in 2001 in order to establish the most appropriate number of procedures to maintain competency. There was a differing opinion between general gynaecologists and urogynaecologists, which is also reflected within our own College in New Zealand [RANZCOG]. In this survey, the majority specialist view was 10–20 procedures per year [among general gynaecologists and urologists] while urogynaecologists and gynaecologists with a special interest stated 20–50 procedures per year. The GRCG is not aware of published evidence for these statements and in particular the relationship of numbers with clinical outcomes related to TVT. Although the GRCG endorsed the recommendation of an annual workload of at least 20 cases [which would be easily achieved in large centres in New Zealand] they added in comment regarding lesser numbers in regional centres but included “with documented good clinical outcomes, which is the bottom line related to surgery in any event. |
1.11.9 Surgeons undertaking continence surgery should maintain careful audit data and submit their outcomes to national registries such as those held by the British Society of Urogynaecology (BSUG) and British Association of Urological Surgeons Section of Female and Reconstructive Urology (BAUS-SFRU). |
1.11.9 Surgeons undertaking continence surgery should maintain careful audit data and submit their outcomes to registries such as the Urogynaecological Society of Australasia (UGSA) pelvic floor database or the Urological Society of Australia and New Zealand (USANZ) sling database. |
Contextual relevance specific to registries for New Zealand |
Some recommendations can be made with more certainty than others. The original NICE Guideline Development Group made recommendations based on the trade-off between the benefits and harms of an intervention, taking into account the quality of the underpinning evidence. For some interventions, the Guideline Development Group is confident that, given the information it has looked at, most patients would choose the intervention. The wording used in the recommendations in this guideline denotes the certainty with which the recommendation is made (the strength of the recommendation).
For all recommendations, NICE expects that there is discussion with the patient about the risks and benefits of the interventions, and their values and preferences. This discussion aims to help them to reach a fully informed decision (see also Patient-centred care). The bpacnz Guideline Review and Contextualisation Group have chosen to utilise the same conventions regarding wording for the strength of recommendations.
Interventions that must (or must not) be used
We utilise the NICE wording of ‘must’ or ‘must not’ only if there is a legal duty to apply the recommendation. Occasionally we use ‘must’ (or ‘must not’) if the consequences of not following the recommendation could be extremely serious or potentially life threatening.
Interventions that should (or should not) be used – a ‘strong’ recommendation
We utilise the NICE wording of ‘offer’ (and similar words such as ‘refer’ or ‘advise’) when we are confident that, for the vast majority of patients, an intervention will do more good than harm, and be cost effective. We use similar forms of words (for example, ‘Do not offer…’) when we are confident that an intervention will not be of benefit for most patients.
Interventions that could be used
We utilise the NICE wording of ‘consider’ when we are confident that an intervention will do more good than harm for most patients, and be cost effective, but other options may be similarly cost effective. The choice of intervention, and whether or not to have the intervention at all, is more likely to depend on the patient’s values and preferences than for a strong recommendation, and so the healthcare professional should spend more time considering and discussing the options with the patient.
Recommendation wording in guideline updates
NICE began using their approach to denote the strength of recommendations in guidelines that started development after publication of a 2009 version of ‘The guidelines manual’ (January 2009). This does not apply to any recommendations ending [2006]. In particular, for recommendations labelled [2006] the word ‘consider’ may not necessarily be used to denote the strength of the recommendation.
UK versions of this guideline
The full NICE guideline, Urinary incontinence in women: the management of urinary incontinence in women (see: www.nice.org.uk/guidance/cg171/evidence), contains details of the methods and evidence used to develop the guideline which has been contextualised. It was published by the National Collaborating Centre for Women’s and Children’s Health.
The recommendations from this guideline have been incorporated into a NICE pathway (see: pathways.nice.org.uk/pathways/urinary-incontinence-in-women
bpacnz has developed supplementary material to help organisations implement this guidance. This can be accessed on the bpacnz website. See: www.bpac.org.nz/guidelines/2/tools.html
This guidance represents the view of bpacnz in contextualising the NICE clinical guideline Urinary Incontinence: The management of urinary incontinence in women (CG171), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summaries of product characteristics of any medicines.
© National Institute for Health and Care Excellence 2015. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
This guideline is an adaptation of Urinary Incontinence: The management of urinary incontinence in women (CG171) © National Institute for Health and Clinical Excellence 2013.