This is the current release of the guideline.

Diseases or conditions that result in lower urinary tract symptoms, including:

• Benign prostate enlargement
• Prostatitis
• Urinary tract infections
• Urological/renal cancers
• Detrusor muscle weakness
• Neurological disease

Diagnosis/Evaluation

1. Patient history and physical exam
2. Symptom scores assessment
3. Digital rectal examination (DRE)
4. Urinary frequency volume chart
5. Urine dipstick test (blood, glucose, protein, leucocytes, nitrites)
6. Prostate specific antigen testing
7. Serum creatinine and estimated glomerular filtration rate
8. Specialist assessment
   • Urinary flow rate
   • Post-void residual volume
   • Cystoscopy
   • Imaging of upper urinary tract
   • Multichannel cystometry
   • Pad tests

Management/Treatment

1. Monitoring of chronic lower urinary tract symptoms (LUTS)
2. Referral to specialist
3. Non-pharmacological interventions
   • Urethral milking
   • Active observation (watchful waiting)
   • Containment/collecting devices (such as catheters, pads, and clamps)
   • Lifestyle and behavioural changes (such as diet, bladder retraining, and pelvic floor exercises)
4. Pharmacological interventions
   • 5-alpha reductase inhibitors
   • Alpha blockers
   • Anticholinergics
   • Other pharmacotherapeutic agents (such as phytotherapy and phosphodiesterase inhibitors, loop diuretics, desmopressin)
   • Combination therapy
5. Surgical interventions for voiding symptoms
   • Transurethral electrovaporisation of the prostate
   • Transurethral radiofrequency needle ablation of the prostate
   • All forms of laser therapy directed at the prostate, including enucleation and vaporisation
   • Transurethral resection of the prostate, including newer forms of therapy such as bipolar excision transurethral incision of the prostate open prostatectomy
   • Combination surgical therapy
6. Surgery for storage symptoms
   • Cystoplasty
   • Bladder wall injection with botulinum toxin
   • Implanted sacral nerve stimulation
   • Urinary diversion
7. Treatment of urinary retention
   • Catheterization
   • Alpha blocker therapy
   • Surgery
8. Active surveillance with regular follow-up
9. Condition-specific information, support, and communication needs of patients, carers, and families

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Clinical Literature Search

The aim of the literature search was to find "evidence within the published literature" to answer the clinical questions identified. We searched clinical databases using relevant medical subject headings and free-text terms. Search filters were used to limit searches to particular study types where applicable. Non-English language studies and abstracts were not excluded from the search but the articles were not reviewed.

Initial searches for each section were performed when the literature was needed for the review. Each search was updated twice nearer the end of guideline development period: once at the beginning of April and then finally, 17 June 2009. No papers after this date were considered.

The following databases were searched:

• The Cochrane Library up to Issue 2 2009
• Medline 1950-2009 (OVID)
• EMBASE 1980-2009 (OVID)
• CINAHL 1982-2009 (Dialog Datastar, later NLH Search 2.0, update searches in EBSCO) - searched for questions relating to patient education and views only.
• PsycINFO 1800s-2009 (NLH Search 2.0, update searches in Ovid) - searched for questions relating to patient education and views only.

There was no systematic attempt to search for grey literature or unpublished literature although all stakeholder references were followed up. We searched for guidelines and reports via relevant urological websites including those listed below.

• Constituent websites of the Guidelines International Network (www.g-i-n.net )
• National Guideline Clearinghouse (www.guideline.gov/ )
• National Institute for Health and Clinical Excellence (NICE) (www.nice.org.uk )
• National Institutes of Health Consensus Development Program (www.consensus.nih.gov/ )
• National Library for Health (www.library.nhs.uk/ )

The results of the searches with the final number of studies meeting the inclusion criteria for the clinical questions are shown in the diagram above.

Economic Literature Search

We obtained published economic evidence from a systematic search of the following databases:

• The Cochrane Library up to Issue 3 2008
• Medline 1950-2009 (OVID)
• EMBASE 1980-2009 (OVID)
• Health economic and evaluations database (HEED) up to August 2008 (access was no longer available after that date).

The information specialists used the same search strategy as for the clinical questions, using an economics filter in the place of a systematic review or randomised controlled trial filter. Each database was searched from its start. Each search was updated twice nearer the end of guideline development period: once at the beginning of April and then finally, 17 June 2009. Papers identified after this date were not considered.

Each search strategy was designed to find any applied study estimating the cost or cost-effectiveness of an included intervention, quality of life literature, and literature relating to economic modelling. A health economist reviewed the abstracts. Relevant references in the bibliographies of reviewed papers were also identified and reviewed.

The search strategies can be found in Appendix C of the full guideline document.

Clinical Literature Reviewing Process

References identified by the systematic literature search were screened for appropriateness by title and abstract by an information scientist and systematic reviewer. Studies were selected that reported one or more of the outcomes listed in section 2.4 of the full guideline document. Selected studies were ordered and assessed in full by the National Clinical Guideline Centre (NCGC) team using agreed inclusion/exclusion criteria specific to the guideline topic, and using NICE methodology quality assessment checklists appropriate to the study design. Further references suggested by the guideline development group were assessed in the same way.

Studies meeting inclusion criteria: 260

Levels of Evidence for Studies of Accuracy of Diagnostic Tests

Ia - Systematic review with homogeneity^a of level 1 studies^b

Ib - Level 1 studies^b

II - Level 2 studies^c; systematic reviews of level 2 studies

III - Level 3 studies^d; 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 indicates there are no or minor variations in the directions and degrees of results between individual studies included in the systematic review

^(b) Level-1 studies:

1. Use a blind comparison of the test with a reference standard (gold standard)
2. Are conducted in a sample of patients that reflects the population to whom the test would apply

^(c) Level-2 studies have only one of the following:

1. Narrow population (sample does not reflect the population to whom the test would apply)
2. A poor reference standard (where tests are not independent)
3. The comparison between the test and reference standard is not masked
4. A case-control study design

^(d) Level-3 studies have two or three of the above features

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

GRADE (Grading of Recommendations Assessment, Development and Evaluation)

The evidence for outcomes from studies which passed the quality assessment were evaluated and presented using "Grading of Recommendations Assessment, Development and Evaluation (GRADE) Toolbox" developed by the international GRADE working group (http://www.gradeworkinggroup.org/ ).

The software (GRADEpro) developed by the GRADE working group was used to assess pooled outcome data using individual study quality assessments and results from meta-analysis.

The summary of findings was presented as two separate tables (see the full guideline document). The "Clinical Study Characteristics" table includes details of the quality assessment while the "Clinical Summary of Findings" table includes pooled outcome data, an absolute measure of intervention effect calculated and the summary of quality of evidence for that outcome. In this table, the columns for intervention and control indicate pooled sample size for continuous outcomes. For binary outcomes such as number of patients with an adverse event, the event rates (n/N) are shown with percentages. Reporting or publication bias was considered in the quality assessment but not included in the Clinical Study Characteristics table because this was a rare reason for downgrading an outcome in this guideline.

Methods of Combining Studies

Where possible, meta-analyses were conducted to combine the results of studies for each clinical question using Cochrane Review Manager (RevMan5) software. Fixed-effects (Mantel-Haenszel) techniques were used to calculate risk ratios (relative risk) for the binary outcomes: number of incontinent patients or adverse events, and the continuous outcome for endpoint or change from baseline International Prostate Symptom Score (IPSS) score, quality of life (QOL) question from IPSS score and Qmax was analysed using an inverse variance method for pooling weighted mean differences. Statistical heterogeneity was assessed by considering the chi-squared test for significance at p<0.05 or an I-squared inconsistency statistic of ≥50% to indicate significant heterogeneity.

Where significant heterogeneity was present we carried out predefined subgroup analyses for: the severity or main type of symptoms experienced by participants recruited into the studies, treatment protocols and length of follow-up. Sensitivity analysis based on the quality of studies was also carried out if there were differences (e.g., open label vs. masked studies). Assessments of potential differences in effect between subgroups were based on the chi-squared tests for heterogeneity statistics between subgroups. If no sensitivity analysis was found to completely resolve statistical heterogeneity then a random effects (DerSimonian and Laird) model was employed to provide a more conservative estimate of the effect.

The standard deviations of continuous outcomes were required for imputation for meta-analysis. However, this was not reported in many studies. In such cases, calculation based on methods outlined in section 7.7.3 of the Cochrane Handbook (February 2008). "Data extraction for continuous outcomes" were applied to estimate the standard deviations if p values of the difference between two means, 95% confidence intervals or standard error of the mean (SEM) had been reported. Where p values were reported as "less than", a conservative approach was undertaken. For example, if p value was reported as "p ≤0.001", the calculations for standard deviations will be based on a p value of 0.001. If these statistical measures were not available, then the methods described in section 16.1.3 of the Cochrane Handbook (February 2008) "Missing standard deviations" were applied as the last resort.

For binary outcomes, absolute event rates were also calculated using the GRADEpro software using event rate in the control arm of the pooled results.

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Clinical questions were developed to guide the literature searching process and to facilitate the development of recommendations by the Guideline Development Group (GDG). They were drafted by the review team and refined and validated by the GDG. The questions were based on the scope (See Appendix A of the full guideline document).

Over the course of the guideline development process, the GDG was presented with the following:

• Evidence tables of the clinical and economic evidence reviewed. All evidence tables are in Appendix D of the full guideline document.
• Summary of clinical evidence and quality (as presented in section write ups)
• Forest plots of meta-analyses (See Appendix E in the full guideline document)
• A description of the methods and results of the cost-effectiveness analysis (See Appendix F of the full guideline document)

Recommendations were drafted on the basis of this evidence whenever it was available.

When clinical and economic evidence was absent, of poor quality or conflicting, the GDG drafted recommendations based on their expert opinion. This may be done through discussions in the GDG, or methods of formal consensus may be applied. The considerations for making these consensus based recommendations include the balance between potential harms and benefits, economic or implications compared to the benefits, current practices, recommendations made in other relevant guidelines, patient preferences and equality issue. The GDG may also consider whether the uncertainty is sufficient to justify delaying making a recommendation to await further research, taking into account the potential harm of failing to make a clear recommendation (See section 2.11 Research Recommendations in the original guideline document). The main considerations specific to each recommendation are outlined in the Linking Evidence to Recommendation Section accompanying these recommendations.

The GDG added supporting recommendations whenever it was necessary in order to improve clinical practice. The supporting recommendations were not derived from clinical questions and were based on GDG expert opinion. The process and considerations for making these supporting recommendations are similar to situations where evidence is lacking or of poor quality, as outlined above.

The development of the recommendations required several steps:

• Whenever possible, a preliminary draft recommendation was presented by National Clinical Guideline Centre (NCGC) staff after each summary of evidence presentation during GDG meetings. This draft was discussed and modified by the GDG to form the first draft recommendation.
• Where necessary, NCGC staff suggested modifications to the draft recommendations as a result of the discussion and in the light of NICE guidance on writing recommendations.
• Towards the end of the guideline development process, a list of all the draft recommendations was sent to the GDG members.
• The GDG members independently completed a consensus exercise to feedback comments and level of agreement on each recommendation. This procedure allowed the NCGC to verify the level of agreement between the GDG members.
• All GDG feedback was collated and circulated again to the GDG. The recommendations which did not have unanimous agreement were discussed again during a GDG meeting before being finalised.
• During the writing up phase of the guideline, the GDG could further refine each recommendation working in subgroups on each chapter.
• NCGC staff verified the consistency of all recommendations across the guideline.

The GDG then developed care pathway algorithms according to the recommendations (see Appendix C of the original guideline document).

Not applicable

Cost-effectiveness Modelling

Two original cost-effectiveness analyses were carried out to answer the clinical questions on transurethral resection of the prostate (TURP) vs. laser, and the clinical question on alpha-blockers (AB) alone or in combination with 5-alpha reductase-inhibitors (5-ARI). Throughout the guideline the guideline developers refer to these two analyses respectively as "National Clinical Guidelines Center (NCGC) Surgery Model" and "NCGC Combination Model".

The following general principles were adhered to:

• The Guideline Development Group (GDG) was consulted during the construction and interpretation of the model.
• When published data was not available expert opinion was used to populate the model.
• Model assumptions were reported fully and transparently.
• The results were subject to sensitivity analysis and limitations were discussed.

The developers followed the methods of the National Institute for Health and Clinical Excellence (NICE) reference case. Therefore, costs were calculated from a health services perspective. Health gain was measured in terms of quality-adjusted life-years (QALYs) gained. Both future costs and QALYs were discounted at 3.5%. The model employed a cost-effectiveness threshold of 20,000 pounds per QALY gained. The model was peer-reviewed by another health economist at the NCGC.

The cost-effectiveness analyses were conducted using TreeAge Pro 2008.

The details of the economic models are described in Appendix F in the full guideline document.

The guideline was validated through two consultations.

1. The first draft of the guideline (The full guideline, National Institute for Health and Clinical Excellence [NICE] guideline and Quick Reference Guide) were consulted with stakeholders and comments were considered by the Guideline Development Group (GDG).
2. The final consultation draft of the full guideline, the NICE guideline and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Care on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.

In this guidance, 'mild' refers to an International Prostate Symptom Score (IPSS) of 0–7, 'moderate' refers to an IPSS of 8–19 and 'severe' refers to an IPSS of 20–35.

Initial Assessment

Initial assessment refers to assessment carried out in any setting by a healthcare professional without specific training in managing LUTS in men.

At initial assessment, offer men with LUTS an assessment of their general medical history to identify possible causes of lower urinary tract symptoms (LUTS), and associated comorbidities. Review current medication, including herbal and over-the-counter medicines, to identify drugs that may be contributing to the problem.

At initial assessment, offer men with LUTS a physical examination guided by urological symptoms and other medical conditions, an examination of the abdomen and external genitalia, and a digital rectal examination (DRE).

At initial assessment, ask men with bothersome LUTS to complete a urinary frequency volume chart.

At initial assessment, offer men with LUTS a urine dipstick test to detect blood, glucose, protein, leucocytes and nitrites.

At initial assessment, offer men with LUTS information, advice and time to decide if they wish to have prostate specific antigen (PSA) testing if:

• Their LUTS are suggestive of bladder outlet obstruction secondary to benign prostatic enlargement (BPE) or
• Their prostate feels abnormal on DRE or
• They are concerned about prostate cancer

Manage suspected prostate cancer in men with LUTS in line with Prostate cancer: diagnosis and treatment (see the NGC summary of the NICE guideline [NICE clinical guideline 58]) and Referral for suspected cancer  (NICE clinical guideline 27).

At initial assessment, offer men with LUTS a serum creatinine test (plus estimated glomerular filtration rate [eGFR] calculation) only if you suspect renal impairment (for example, the man has a palpable bladder, nocturnal enuresis, recurrent urinary tract infections or a history of renal stones).

Do not routinely offer cystoscopy to men with uncomplicated LUTS (that is, without evidence of bladder abnormality) at initial assessment.

Do not routinely offer imaging of the upper urinary tract to men with uncomplicated LUTS at initial assessment.

Do not routinely offer flow-rate measurement to men with LUTS at initial assessment.

Do not routinely offer a post void residual volume measurement to men with LUTS at initial assessment.

At initial assessment, give reassurance, offer advice on lifestyle interventions (for example, fluid intake) and information on their condition to men whose LUTS are not bothersome or complicated. Offer review if symptoms change.

Offer men referral for specialist assessment if they have bothersome LUTS that have not responded to conservative management or drug treatment.

Refer men for specialist assessment if they have LUTS complicated by recurrent or persistent urinary tract infection, retention, renal impairment that is suspected to be caused by lower urinary tract dysfunction, or suspected urological cancer.

Offer men considering any treatment for LUTS an assessment of their baseline symptoms with a validated symptom score (for example, the IPSS) to allow assessment of subsequent symptom change.

Specialist Assessment

Specialist assessment refers to assessment carried out in any setting by a healthcare professional with specific training in managing LUTS in men.

Offer men with LUTS having specialist assessment an assessment of their general medical history to identify possible causes of LUTS, and associated comorbidities. Review current medication, including herbal and over-the-counter medicines to identify drugs that may be contributing to the problem.

Offer men with LUTS having specialist assessment a physical examination guided by urological symptoms and other medical conditions, an examination of the abdomen and external genitalia, and a DRE.

At specialist assessment, ask men with LUTS to complete a urinary frequency volume chart.

At specialist assessment, offer men with LUTS information, advice and time to decide if they wish to have PSA testing if:

• Their LUTS are suggestive of bladder outlet obstruction secondary to BPE or
• Their prostate feels abnormal on DRE or
• They are concerned about prostate cancer

Offer men with LUTS who are having specialist assessment a measurement of flow rate and post void residual volume.

Offer cystoscopy to men with LUTS having specialist assessment only when clinically indicated, for example if there is a history of any of the following:

• Recurrent infection
• Sterile pyuria
• Haematuria
• Profound symptoms
• Pain

Offer imaging of the upper urinary tract to men with LUTS having specialist assessment only when clinically indicated, for example if there is a history of any of the following:

• Chronic retention
• Haematuria
• Recurrent infection
• Sterile pyuria
• Profound symptoms
• Pain

Consider offering multichannel cystometry to men with LUTS having specialist assessment if they are considering surgery.

Offer pad tests to men with LUTS having specialist assessment only if the degree of urinary incontinence needs to be measured.

Conservative Management

Explain to men with post micturition dribble how to perform urethral milking.

Offer men with storage LUTS (particularly urinary incontinence) temporary containment products (for example, pads or collecting devices) to achieve social continence until a diagnosis and management plan have been discussed.

Offer a choice of containment products to manage storage LUTS (particularly urinary incontinence) based on individual circumstances and in consultation with the man.

Offer men with storage LUTS suggestive of overactive bladder (OAB) supervised bladder training, advice on fluid intake, lifestyle advice and, if needed, containment products.

Inform men with LUTS and proven bladder outlet obstruction that bladder training is less effective than surgery.

Offer supervised pelvic floor muscle training to men with stress urinary incontinence caused by prostatectomy. Advise them to continue the exercises for at least 3 months before considering other options.

Refer for specialist assessment men with stress urinary incontinence.

Do not offer penile clamps to men with storage LUTS (particularly urinary incontinence).

Offer external collecting devices (for example, sheath appliances, pubic pressure urinals) for managing storage LUTS (particularly urinary incontinence) in men before considering indwelling catheterisation.

Offer intermittent bladder catheterisation before indwelling urethral or suprapubic catheterisation to men with voiding LUTS that cannot be corrected by less invasive measures.

Consider offering long-term indwelling urethral catheterisation to men with LUTS:

• For whom medical management has failed and surgery is not appropriate and
• Who are unable to manage intermittent self-catheterisation or
• With skin wounds, pressure ulcers or irritation that are being contaminated by urine or
• Who are distressed by bed and clothing changes

If offering long-term indwelling catheterisation, discuss the practicalities, benefits and risks with the man and, if appropriate, his carer.

Explain to men that indwelling catheters for urgency incontinence may not result in continence or the relief of recurrent infections.

Consider permanent use of containment products for men with storage LUTS (particularly urinary incontinence) only after assessment and exclusion of other methods of management.

Drug Treatment

Offer drug treatment only to men with bothersome LUTS when conservative management options have been unsuccessful or are not appropriate.

Take into account comorbidities and current treatment when offering men drug treatment for LUTS.

Offer an alpha blocker (alfuzosin, doxazosin, tamsulosin or terazosin) to men with moderate to severe LUTS.

Offer an anticholinergic to men to manage the symptoms of OAB.

Offer a 5-alpha reductase inhibitor to men with LUTS who have prostates estimated to be larger than 30 g or a prostate specific antigen (PSA) level greater than 1.4 ng/ml, and who are considered to be at high risk of progression (for example, older men).

Consider offering a combination of an alpha blocker and a 5-alpha reductase inhibitor to men with bothersome moderate to severe LUTS and prostates estimated to be larger than 30 g or a PSA level greater than 1.4 ng/ml.

Consider offering an anticholinergic as well as an alpha blocker to men who still have storage symptoms after treatment with an alpha blocker alone.

Consider offering a late afternoon loop diuretic* to men with nocturnal polyuria.

Consider offering oral desmopressin** to men with nocturnal polyuria if other medical causes*** have been excluded and they have not benefited from other treatments. Measure serum sodium 3 days after the first dose. If serum sodium is reduced to below the normal range, stop desmopressin treatment.

*At the time of publication (May 2010), loop diuretics (for example, furosemide) did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented.

**At the time of publication (May 2010), desmopressin did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented. Consult the summary of product characteristics for the contraindications and precautions.

***Medical conditions that can cause nocturnal polyuria symptoms include diabetes mellitus, diabetes insipidus, adrenal insufficiency, hypercalcaemia, liver failure, polyuric renal failure, chronic heart failure, obstructive apnoea, dependent oedema, pyelonephritis, chronic venous stasis, sickle cell anaemia. Medications that can cause nocturnal polyuria symptoms include calcium channel blockers, diuretics, selective serotonin reuptake inhibitors (SSRIs) antidepressants.

Review

Discuss active surveillance (reassurance and lifestyle advice without immediate treatment and with regular follow-up) or active intervention (conservative management, drug treatment or surgery) for:

• Men with mild or moderate bothersome LUTS
• Men whose LUTS fail to respond to drug treatment

Review men taking drug treatments to assess symptoms, the effect of the drugs on the patient's quality of life and to ask about any adverse effects from treatment.

Review men taking alpha blockers at 4–6 weeks and then every 6–12 months.

Review men taking 5-alpha reductase inhibitors at 3–6 months and then every 6–12 months.

Review men taking anticholinergics every 4–6 weeks until symptoms are stable, and then every 6–12 months.

Surgery for Voiding Symptoms

For men with voiding symptoms, offer surgery only if voiding symptoms are severe or if drug treatment and conservative management options have been unsuccessful or are not appropriate. Discuss the alternatives to and outcomes from surgery.

If offering surgery for managing voiding LUTS presumed secondary to BPE, offer monopolar or bipolar transurethral resection of the prostate (TURP), monopolar transurethral vaporisation of the prostate (TUVP) or holmium laser enucleation of the prostate (HoLEP). Perform HoLEP at a centre specialising in the technique, or with mentorship arrangements in place.

Offer transurethral incision of the prostate (TUIP) as an alternative to other types of surgery to men with a prostate estimated to be smaller than 30 g.

Only offer open prostatectomy as an alternative to TURP, TUVP or HoLEP to men with prostates estimated to be larger than 80 g.

If offering surgery for managing voiding LUTS presumed secondary to BPE, do not offer minimally invasive treatments (including transurethral needle ablation [TUNA], transurethral microwave thermotherapy [TUMT], high-intensity focused ultrasound [HIFU], transurethral ethanol ablation of the prostate [TEAP] and laser coagulation) as an alternative to TURP, TUVP or HoLEP.

If offering surgery for managing voiding LUTS presumed secondary to BPE, only consider offering botulinum toxin injection into the prostate as part of a randomised controlled trial.

If offering surgery for managing voiding LUTS presumed secondary to BPE, only consider offering laser vaporisation techniques, bipolar TUVP or monopolar or bipolar transurethral vaporisation resection of the prostate (TUVRP) as part of a randomised controlled trial that compares these techniques with TURP.

Surgery for Storage Symptoms

If offering surgery for storage symptoms, consider offering only to men whose storage symptoms have not responded to conservative management and drug treatment. Discuss the alternatives of containment or surgery. Inform men being offered surgery that effectiveness, side effects and long-term risk are uncertain.

If considering offering surgery for storage LUTS, refer men to a urologist to discuss:

• The surgical and non-surgical options appropriate for their circumstances and
• The potential benefits and limitations of each option, particularly long-term results

Consider offering cystoplasty to manage detrusor overactivity only to men whose symptoms have not responded to conservative management or drug treatment and who are willing and able to self-catheterise. Before offering cystoplasty, discuss serious complications (that is, bowel disturbance, metabolic acidosis, mucus production and/or mucus retention in the bladder, urinary tract infection and urinary retention).

Consider offering bladder wall injection with botulinum toxin**** to men with detrusor overactivity only if their symptoms have not responded to conservative management and drug treatments and the man is willing and able to self-catheterise.

Consider offering implanted sacral nerve stimulation to manage detrusor overactivity only to men whose symptoms have not responded to conservative management and drug treatments.

Do not offer myectomy to men to manage detrusor overactivity.

Consider offering intramural injectables, implanted adjustable compression devices and male slings to manage stress urinary incontinence only as part of a randomised controlled trial.

Consider offering urinary diversion to manage intractable urinary tract symptoms only to men whose symptoms have not responded to conservative management and drug treatments, and if cystoplasty or sacral nerve stimulation are not clinically appropriate or are unacceptable to the patient.

Consider offering implantation of an artificial sphincter to manage stress urinary incontinence only to men whose symptoms have not responded to conservative management and drug treatments.

****At the time of publication (May 2010), botulinum toxin did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented.

Treating Urinary Retention

Immediately catheterize men with acute retention.

Offer an alpha blocker to men for managing acute urinary retention before removal of the catheter.

Consider offering self- or carer-administered intermittent urethral catheterisation before offering indwelling catheterisation for men with chronic urinary retention.

Carry out a serum creatinine test and imaging of the upper urinary tract in men with chronic urinary retention (residual volume greater than 1 litre or presence of a palpable/percussable bladder).

Catheterise men who have impaired renal function or hydronephrosis secondary to chronic urinary retention.

Consider offering intermittent or indwelling catheterisation before offering surgery in men with chronic urinary retention.

Consider offering surgery on the bladder outlet without prior catheterisation to men who have chronic urinary retention and other bothersome LUTS but no impairment of renal function or upper renal tract abnormality.

Consider offering intermittent self- or carer-administered catheterisation instead of surgery in men with chronic retention who you suspect have markedly impaired bladder function.

Continue or start long-term catheterisation in men with chronic retention for whom surgery is unsuitable.

Provide active surveillance (post void residual volume measurement, upper tract imaging and serum creatinine testing) to men with non-bothersome LUTS secondary to chronic retention who have not had their bladder drained.

Alternative and Complementary Therapies

Do not offer homeopathy, phytotherapy or acupuncture for treating LUTS in men.

Providing Information

Ensure that, if appropriate, men’s carers are informed and involved in managing their LUTS and can give feedback on treatments.

Make sure men with LUTS have access to care that can help with:

• Their emotional and physical conditions and
• Relevant physical, emotional, psychological, sexual and social issues

Provide men with storage LUTS (particularly incontinence) containment products at point of need, and advice about relevant support groups.

The following clinical algorithms are provided in the appendices of the original guideline document:

• Diagnosis
• Chronic urinary retention (specialist care)
• Predominant storage symptoms
• Predominant voiding symptoms

The type of evidence supporting the recommendations is not specifically stated.

Appropriate diagnosis and treatment of lower urinary tract symptoms in men

Adverse outcomes of treatment or invasive diagnostic investigations

The Healthcare Commission assesses the performance of National Health Service (NHS) organisations in meeting core and developmental standards set by the Department of Health in 'Standards for better health' (available from www.dh.gov.uk ). Implementation of clinical guidelines forms part of the developmental standard D2. Core standard C5 states that national agreed guidance should be taken into account when NHS organisations are planning and delivering care.

The National Institute for Health and Clinical Excellence (NICE) has developed tools to help organisations implement this guidance. These are available on the NICE Web site (http://guidance.nice.org.uk/CG97 ; see also the "Availability of Companion Documents" field).

Key Priorities for Implementation

Initial Assessment

• At initial assessment, offer men with lower urinary tract symptoms (LUTS) an assessment of their general medical history to identify possible causes of LUTS, and associated comorbidities. Review current medication, including herbal and over-the-counter medicines, to identify drugs that may be contributing to the problem.
• At initial assessment, offer men with LUTS a physical examination guided by urological symptoms and other medical conditions, an examination of the abdomen and external genitalia, and a digital rectal examination (DRE).
• At initial assessment, ask men with bothersome LUTS to complete a urinary frequency volume chart.
• Refer men for specialist assessment if they have LUTS complicated by recurrent or persistent urinary tract infection, retention, renal impairment that is suspected to be caused by lower urinary tract dysfunction, or suspected urological cancer.

Conservative Management

• Offer men with storage LUTS (particularly urinary incontinence) temporary containment products (for example, pads or collecting devices) to achieve social continence until a diagnosis and management plan have been discussed.
• Offer men with storage LUTS suggestive of overactive bladder (OAB) supervised bladder training, advice on fluid intake, lifestyle advice and, if needed, containment products.

Surgery for Voiding Symptoms

• If offering surgery for managing voiding LUTS presumed secondary to BPE, offer monopolar or bipolar transurethral resection of the prostate (TURP), monopolar transurethral vaporisation of the prostate (TUVP) or holmium laser enucleation of the prostate (HoLEP). Perform HoLEP at a centre specialising in the technique, or with mentorship arrangements in place.
• If offering surgery for managing voiding LUTS presumed secondary to BPE, do not offer minimally invasive treatments (including transurethral needle ablation [TUNA], transurethral microwave thermotherapy [TUMT], high-intensity focused ultrasound [HIFU], transurethral ethanol ablation of the prostate [TEAP] and laser coagulation) as an alternative to TURP, TUVP or HoLEP (see section 1.5.2 in the original guideline document).

Providing Information

• Make sure men with LUTS have access to care that can help with:
  • Their emotional and physical conditions and
  • Relevant physical, emotional, psychological, sexual and social issues
• Provide men with storage LUTS (particularly incontinence) containment products at point of need, and advice about relevant support groups.

Not applicable: The guideline was not adapted from another source.

National Institute for Health and Clinical Excellence (NICE)

Guideline Development Group

Guideline Development Group Members: Professor Christopher Chapple (Chair), Consultant Urological Surgeon, The Royal Hallamshire Hospital, Sheffield; Ms Angela Billington, Director of Continence Services, Bournemouth and Poole Community Health Services; Mr Paul Joachim, Patient Member, Chair of the Patient Advisory board, The Bladder and Bowel Foundation (InContact); Mr Thomas Ladds, Urology Specialist Nurse Practitioner, Central Manchester Hospitals NHS Trust (until February 2009); Mr Roy Latham, Patient Member, Member of Royal College of Physicians Patient Carer Network; Mr Malcolm Lucas, Consultant Urological Surgeon, Abertawe Bro Morgannwg University Local Health board; Professor James N’Dow, Consultant Urological Surgeon, University of Aberdeen and NHS Grampian; Dr Jon Rees, General Practitioner, Nailsea, Bristol; Dr Julian Spinks, General Practitioner, Strood, Kent; Mr Mark Speakman, Consultant Urological Surgeon, Taunton and Somerset NHS Trust; Mr William Turner, Consultant Urological Surgeon, Addenbrooke's Hospital, Cambridge; Dr Adrian Wagg Consultant Geriatrician, UCL Hospitals Foundation NHS Trust and Camden PCT

All members of the Guideline Development Group (GDG) and all members of the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) staff were required to make formal declarations of interest at the outset, and these were updated at every subsequent meeting throughout the development process. The GDG members' declarations of interests are listed in Appendix B of the full version of the original guideline document (see "Availability of Companion Documents").

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site .

The following is available:

• Lower urinary tract symptoms. The management of lower urinary tract symptoms in men. Quick reference guide. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 16 p. (Clinical guideline; no. CG97). Electronic copies: Available in Portable Document Format (PDF) from the NICE Web site . of lower urinary tract symptoms in men. Full guideline. London (UK): National Institute for Health and Clinical Excellence; 2010 May. 355 p. (Clinical guideline; no. CG97). Electronic copies: Available in PDF from the NICE Web site .
• Lower urinary tract symptoms. Costing report. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence; 2010 May. 29 p. (Clinical guideline; no. CG97). Electronic copies: Available in PDF format from the NICE Web site .
• Lower urinary tract symptoms. Costing template. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence; 2010 May. (Clinical guideline; no. CG97). Electronic copies: Available from the NICE Web site .
• Lower urinary tract symptoms. Audit support. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence; 2010 May. 2 p. (Clinical guideline; no. CG97). Electronic copies: Available in PDF from the NICE Web site .
• Lower urinary tract symptoms. Slide set. London (UK): National Institute for Health and Clinical Excellence; 2010 May. 15 p. (Clinical guideline; no. CG97). Electronic copies: Available from the NICE Web site .
• Lower urinary tract symptoms. Baseline assessment tool. Implementing NICE guidance. London (UK). National Institute for Health and Clinical Excellence; 2010 May. (Clinical guideline; no. CG97). Electronic copies: Available from the NICE Web site .
• Lower urinary tract symptoms. Implementation advice. London (UK): National Institute for Health and Clinical Excellence; 2010 Jul. 28 p. (Clinical guideline; no. CG97). Electronic copies: Available in PDF format from the NICE Web site .
• Lower urinary tract symptoms. Implementation briefing for general practitioners (GPs). Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence; 2010 Jun. 6 p. (Clinical guideline; no. CG97). Electronic copies: Available in PDF from the NICE Web site .
• Lower urinary tract symptoms. Implementation briefing for pharmacists. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence; 2010 Jun. 6 p. (Clinical guideline; no. CG97). Electronic copies: Available in PDF from the NICE Web site .

The following is available:

• Lower urinary tract symptoms. Understanding NICE guidance. Information for people who use NHS services. National Institute for Health and Clinical Excellence (NICE), 2010 May. 12 p. (Clinical guideline; no. CG97). Electronic copies: Available from the NICE Web site . Also available in Welsh from the NICE Web site .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

This summary was completed by ECRI Institute on January 5, 2011. This summary was updated by ECRI Institute on June 16, 2011 following the FDA advisory on 5-alpha reductase inhibitors (5-ARIs).

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their clinical guidelines with the intention of disseminating and facilitating the implementation of that guidance. NICE has not yet verified this content to confirm that it accurately reflects that original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE clinical guidelines are prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk .

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.