Evidence categories for intervention studies (1++ through 4), evidence categories (Ia-IV) for studies of the accuracy of diagnostic tests, and recommendation grades (A-D) are defined at the end of the "Major Recommendations" field.
In addition to evidence-based recommendations, the guideline development group (GDG) also identifies good practice points (GPPs).
Assessment and Investigation
History Taking and Physical Examination
D (GPP) - At the initial clinical assessment, the woman's urinary incontinence (UI) should be categorised as stress urinary incontinence (SUI), mixed UI, or urge UI/overactive bladder (OAB). Initial treatment should be started on this basis. In mixed UI, treatment should be directed towards the predominant symptom.
D (GPP) - The clinical assessment should seek to identify relevant predisposing and precipitating factors and other diagnoses that may require referral for additional investigation and treatment.
Pelvic Floor Muscle Assessment
D (GPP) - Routine digital assessment of pelvic floor muscle contraction should be undertaken before the use of supervised pelvic floor muscle training for the treatment of UI.
Assessment of Prolapse
D (GPP) - Women with UI who have symptomatic prolapse that is visible at or below the vaginal introitus should be referred to a specialist.
Urine Testing
D (GPP) - A urine dipstick test should be undertaken in all women presenting with UI to detect the presence of blood, glucose, protein, leucocytes and nitrites in the urine.
D (GPP) - Women with symptoms of urinary tract infection (UTI) whose urine tests positive for both leucocytes and nitrites should have a midstream urine specimen sent for culture and analysis of antibiotic sensitivities. An appropriate course of antibiotic treatment should be prescribed pending culture results.
D (GPP) - Women with symptoms of UTI whose urine tests negative for either leucocytes or nitrites should have a midstream urine specimen sent for culture and analysis of antibiotic sensitivities. The healthcare professional should consider the prescription of antibiotics pending culture results.
D (GPP) - Women who do not have symptoms of UTI, but whose urine tests positive for both leucocytes and nitrites, should not be offered antibiotics without the results of midstream urine culture.
B (DS) - Women who do not have symptoms of UTI and whose urine tests negative for either leucocytes or nitrites are unlikely to have UTI and should not have a urine sample sent for culture.
Assessment of Residual Urine
B (DS) - The measurement of post-void residual volume by bladder scan or catheterisation should be performed in women with symptoms suggestive of voiding dysfunction or recurrent UTI.
D (GPP) - A bladder scan should be used in preference to catheterisation on the grounds of acceptability and lower incidence of adverse events.
D (GPP) - Women who are found to have a palpable bladder on bimanual or abdominal examination after voiding should be referred to a specialist.
Referral
D (GPP) - Women with UI who have any of the following should receive an urgent* referral:
- 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
Indications for referral are:
- Symptomatic prolapse that is visible at or below the vaginal introitus ("Assessment of Prolapse" section above)
- The finding of a palpable bladder on bimanual or abdominal examination after voiding ("Assessment of Residual Urine" section above).
In women with UI, further indications for consideration for referral to a specialist service include:
- Persisting bladder or urethral pain
- Clinically benign pelvic masses
- Associated faecal incontinence
- Suspected neurological disease
- Symptoms of voiding difficulty
- Suspected urogenital fistulae
- Previous continence surgery
- Previous pelvic cancer surgery
- Previous pelvic radiation therapy
*NICE's Referral Guidelines for Suspected Cancer define urgent referral as the patient being seen within the national target for urgent referrals (currently 2 weeks).
**Haematuria visible with the aid of a microscope.
Symptom Scoring and Quality of Life Assessment
D (GPP) - The following incontinence-specific quality of life scales are recommended when therapies are being evaluated: International Consultation on Incontinence questionnaire (ICIQ), Bristol Female Lower Urinary Tract Symptoms (questionnaire) (BFLUTS), Incontinence Quality of Life (questionnaire) (I-QOL), Stress and Urge Incontinence Quality of Life questionnaire (SUIQQ), Urinary Incontinence Severity Score (UISS), SEAPI-QMM incontinence classification system, Incontinence Severity Index (ISI), and King's Health Questionnaire (KHQ).
Bladder Diaries
D (GPP) - Bladder diaries should be used in the initial assessment of women with UI or OAB. Women should be encouraged to complete a minimum of 3 days of the diary, covering variations in their usual activities, such as both working and leisure days.
Pad Testing
D - Pad tests are not recommended in the routine assessment of women with UI.
Urodynamic Testing
D - The use of multichannel cystometry, ambulatory urodynamics or videourodynamics is not recommended before starting conservative treatment.
D - For the small group of women with a clearly defined clinical diagnosis of pure stress UI, the use of multichannel cystometry is not routinely recommended.
D (GPP) - Multichannel filling and voiding cystometry is recommended in women before surgery for UI if:
- There is clinical suspicion of detrusor overactivity
- There has been previous surgery for stress incontinence or anterior compartment prolapse
- There are symptoms suggestive of voiding dysfunction
Ambulatory urodynamics or videourodynamics may also be considered in these circumstances.
Other Tests of Urethral Competence
D - The Q-tip, Bonney, Marshall and Fluid-Bridge tests are not recommended in the assessment of women with UI.
Cystoscopy
D (GPP) - Cystoscopy is not recommended in the initial assessment of women with UI alone.
Imaging
D - Imaging (magnetic resonance imaging, computed tomography, X-ray) is not recommended for the routine assessment of women with UI. Ultrasound is not recommended other than for the assessment of residual urine volume.
Conservative Management
Lifestyle Interventions
D - A trial of caffeine reduction is recommended for the treatment of women with OAB.
D (GPP) - Consider advising modification of high or low fluid intake for the treatment of women with UI or OAB.
D - Women with UI or OAB who have a body mass index greater than 30 should be advised to lose weight.
Physical Therapies
A - A trial of supervised pelvic floor muscle training of at least 3 months' duration should be offered as first-line treatment to women with stress or mixed UI.
A - Pelvic floor muscle training programmes should comprise at least eight contractions performed three times per day.
D (GPP) - If pelvic floor muscle training is beneficial, an exercise programme should be maintained.
A - Perineometry or pelvic floor electromyography as biofeedback should not be used as a routine part of pelvic floor muscle training.
D - Electrical stimulation should not routinely be used in the treatment of women with OAB.
A - Electrical stimulation should not routinely be used in combination with pelvic floor muscle training.
D (GPP) - 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.
Behavioural Therapies
A - Bladder training lasting for a minimum of 6 weeks should be offered as first-line treatment to women with urge or mixed UI.
A - If women do not achieve satisfactory benefit from bladder training programmes, the combination of an antimuscarinic agent with bladder training should be considered if frequency is a troublesome symptom.
A - In women with UI who also have cognitive impairment, prompted and timed voiding toileting programmes are recommended as strategies for reducing leakage episodes.
Drug Therapies
A - Immediate release non-proprietary oxybutynin should be offered to women with OAB or mixed UI as first-line antimuscarinic drug treatment if bladder training has been ineffective. If immediate release oxybutynin is not well tolerated, darifenacin, solifenacin, tolterodine, trospium or an extended release or transdermal formulation of oxybutynin should be considered as alternatives. Women should be counselled about the adverse effects of antimuscarinic drugs.
D (GPP) - An early treatment review should be undertaken following any change in antimuscarinic drug therapy.
A - Propiverine should be considered as an option to treat frequency of urination in women with OAB, but is not recommended for the treatment of UI.
A - Flavoxate, propantheline and imipramine should not be used for the treatment of UI or OAB in women.
A - The use of desmopressin may be considered specifically to reduce nocturia in women with UI or OAB who find it a troublesome symptom.
However, the use of desmopressin for nocturia in women with idiopathic UI is outside the UK marketing authorisation for the product. Informed consent to treatment should be obtained and documented.
A - Duloxetine is not recommended as a first-line treatment for women with predominant stress UI. Duloxetine should not routinely be used 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, women should be counselled about its adverse effects.
A - Systemic hormone replacement therapy is not recommended for the treatment of UI.
A - Intravaginal oestrogens are recommended for the treatment of OAB symptoms in postmenopausal women with vaginal atrophy.
Non-Therapeutic Interventions
D (GPP) - Absorbent products, hand-held urinals and toileting aids should not be considered as a treatment for UI. They should be used only as:
- A coping strategy pending definitive treatment
- An adjunct to other ongoing therapy
- Long-term management of UI only after treatment options have been explored
D (GPP) - 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 urge UI may not result in continence.
C - Intermittent urethral catheterisation should be used for women with urinary retention who can be taught to self-catheterise or who have a carer who can perform the technique.
D (GPP) - Careful consideration should be given to the impact of long-term indwelling urethral catheterisation. The practicalities, benefits and risks should be discussed with the patient or, if appropriate, her carer. Indications for the use of long-term indwelling urethral catheters for women with UI include:
- Chronic urinary retention in women who are unable to manage intermittent self-catheterisation
- Skin wounds, pressure ulcers or irritations that are being contaminated by urine
- Distress or disruption caused by bed and clothing changes
- Where a woman expresses a preference for this form of management
D (GPP) - Indwelling suprapubic catheters should be considered as an alternative to long-term urethral catheters. Healthcare professionals should 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.
D (GPP) - Intravaginal and intraurethral devices are not recommended for the routine management of UI in women. Women should not be advised to consider such devices other than for occasional use when necessary to prevent leakage, for example during physical exercise.
Complementary Therapies
D - Complementary therapies are not recommended for the treatment of UI or OAB.
Preventive Use of Conservative Therapies
A - Pelvic floor muscle training should be offered to women in their first pregnancy as a preventive strategy for UI.
Surgical Management
D (GPP) - Any woman wishing to consider surgical treatment for UI should be informed about the benefits and risks of surgical and non-surgical options. Counselling should include consideration of the woman's childbearing wishes.
Procedures for Overactive Bladder
D - Sacral nerve stimulation is recommended for the treatment of UI due to detrusor overactivity in women who have not responded to conservative treatments. Women should be offered sacral nerve stimulation on the basis of their response to preliminary percutaneous nerve evaluation. Life-long follow-up is recommended.
D (GPP) - Augmentation cystoplasty for the management of idiopathic detrusor overactivity should be restricted to women who have not responded to conservative treatments and who are willing and able to self-catheterise. Preoperative counselling should include common and serious complications: bowel disturbance, metabolic acidosis, mucus production and/or retention in the bladder, UTI and urinary retention. The small risk of malignancy occurring in the augmented bladder should also be discussed. Life-long follow-up is recommended.
D (GPP) - Urinary diversion should be considered for a woman with OAB only when conservative treatments have failed, and if sacral nerve stimulation and augmentation cystoplasty are not appropriate or are unacceptable to her. Life-long follow-up is recommended.
D - Bladder wall injection with botulinum toxin A should be used in the treatment of idiopathic detrusor overactivity only in women who have not responded to conservative treatments and who are willing and able to self-catheterise. Women should be informed about the lack of long-term data. There should be special arrangements for audit or research.
The use of botulinum toxin A for this indication is outside the UK marketing authorization for the product. Informed consent to treatment should be obtained and documented.
D - Botulinum toxin B is not recommended for the treatment of women with idiopathic OAB.
Procedures for Stress Urinary Incontinence
A - Retropubic mid-urethral tape procedures using a "bottom-up" approach with macroporous (type 1) polypropylene meshes are recommended as treatment options for stress UI if conservative management has failed. Open colposuspension and autologous rectus fascial sling are the recommended alternatives when clinically appropriate.
D - Synthetic slings using a retropubic 'top-down' or a transobturator foramen approach are recommended as alternative treatment options for stress UI if conservative management has failed, provided women are made aware of the lack of long-term outcome data.
D - Synthetic slings using materials other than polypropylene that are not of a macroporous (type 1) construction are not recommended for the treatment of stress UI.
D - Intramural bulking agents (glutaraldehyde cross-linked collagen, silicone, carbon coated zirconium beads or hyaluronic acid/dextran copolymer) should be considered for the management of stress UI if conservative management has failed. Women should be made aware that:
- Repeat injections may be required to achieve efficacy
- Efficacy diminishes with time
- Efficacy is inferior to that of retropubic suspension or sling
D - 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.
D (GPP) - Laparoscopic colposuspension is not recommended as a routine procedure for the treatment of stress UI in women. The procedure should be performed only by an experienced laparoscopic surgeon working in a multidisciplinary team with expertise in the assessment and treatment of UI.
A - Anterior colporrhaphy, needle suspensions, paravaginal defect repair and the Marshall– Marchetti–Krantz procedure are not recommended for the treatment of stress UI.
D - Autologous fat and polytetrafluoroethylene used as intramural bulking agents are not recommended for the treatment of stress UI.
For recommendations on the "Competence of Surgeons Performing Operative Procedures for Urinary Incontinence in Women" please refer to the original full-length guideline document.
Definitions:
Levels of Evidence for Intervention Studies
| Level |
Source of Evidence |
| 1++ |
Well-conducted meta-analyses, systematic reviews of RCTs or RCTs with a low risk of bias |
| 1+ |
Meta-analyses, systematic reviews of RCTs or RCTs with a high risk of bias |
| 1- |
High-quality systematic reviews of case–control or cohort studies; high-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal |
| 2++ |
High-quality meta-analyses, systematic reviews of randomized controlled trials (RCTs) or RCTs with a very low risk of bias |
| 2+ |
Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal |
| 2– |
Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal |
| 3 |
Non-analytical studies (for example case reports, case series) |
| 4 |
Expert opinion, formal consensus |
Levels of Evidence for Studies of the Accuracy of Diagnostic Tests
| Ia |
Systematic review (with homogeneity)a of level-1 studiesb |
| Ib |
Level-1 studiesb |
| II |
Level-2 studiesc; systematic reviews of level-2 studies |
| III |
Level-3 studiesd; systematic reviews of level-3 studies |
| IV |
Consensus, expert committee reports or opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or 'first principles' |
a Homogeneity means there are minor or no variations in the directions and degrees of results between individual studies that are included in the systematic review.
b Level-1 studies are studies that use a blind comparison of the test with a validated reference standard ('gold' standard) in a sample of patients that reflects the population to whom the test would apply.
c Level-2 studies are studies that have only one of the following:
- Narrow population (the sample does not reflect the population to whom the test would apply)
- Use a poor reference standard (defined as that where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference')
- The comparison between the test and reference standard is not blind
- Case-control studies
d Level-3 studies are studies that have at least two or three of the features listed above.
Classification (Grading) of Recommendations for Intervention Studies
| Grade |
Evidence |
| A |
- At least one meta-analysis, systematic review or randomised controlled trial (RCT) that is rated as 1++, and is directly applicable to the target population, or
- A systematic review of RCTs or a body of evidence that consists principally of studies rated as 1+, is directly applicable to the target population and demonstrates overall consistency of results, or
- Evidence drawn from a National Institute for Health and Clinical Excellence (NICE) technology appraisal
|
| B |
- A body of evidence that includes studies rated as 2++, is directly applicable to the target population and demonstrates overall consistency of results, or
- Extrapolated evidence from studies rated as 1++ or 1+
|
| C |
- A body of evidence that includes studies rated as 2+, is directly applicable to the target population and demonstrates overall consistency of results, or
- Extrapolated evidence from studies rated as 2++
|
| D |
- Evidence level 3 or 4, or
- Extrapolated evidence from studies rated as 2+, or
- Formal consensus
|
| D (GPP) |
- A good practice point (GPP) is a recommendation for best practice based on the experience of the Guideline Development Group.
|
Classification (Grading) of Recommendations for Studies of the Accuracy of Diagnostic Tests
| Grade |
Level of Evidence |
A (DS)
B (DS)
C (DS)
D (DS)
|
Studies with level of evidence Ia or Ib
Studies with level of evidence of II
Studies with level of evidence of III
Studies with level of evidence of IV
|
DS, diagnostic study
