Bibliographic Source(s)

• Finnish Medical Society Duodecim. Benign prostatic hyperplasia. In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki Finland: Wiley Interscience. John Wiley & Sons; 2008 Sep 27 [Various].

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Finnish Medical Society Duodecim. Benign prostatic hyperplasia. In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki Finland: Wiley Interscience. John Wiley & Sons; 2007 Apr 16 [Various].

Guideline Category

Diagnosis
Evaluation
Treatment

Intended Users

Health Care Providers
Physicians

Guideline Objective(s)

Evidence-Based Medicine Guidelines collect summarize and update the core clinical knowledge essential in general practice. The guidelines also describe the scientific evidence underlying the given recommendations.

Target Population

Men with suspected or confirmed benign prostatic hyperplasia

Interventions and Practices Considered

Diagnosis/Evaluation

Primary Investigations

1. Assessment of signs and symptoms
   • Storage symptoms
   • Voiding symptoms

2. Symptom questionnaire (e.g. International Prostatic Symptom Score [IPSS])
3. Writing down details associated with voiding
4. Digital rectal examination (DRE)
5. Urinalysis
6. Serum/plasma creatinine
7. Serum prostate-specific antigen (PSA)
8. Residual urine volume as determined by ultrasonography or catheterization
9. Differential diagnosis
10. Specialist consultation when indicated

Investigations Performed by Urologist

1. Urine flow measurement
2. Transrectal ultrasonography
3. Cystometry and pressure-flow examination
4. Urethrocystography
5. Urography
6. Prostatic biopsies
7. Cystoscopy

Treatment

1. Conservative treatment
   • Follow-up

2. Drug treatment
   • Alpha₁-blockers
   • 5-alpha-reductase inhibitors
   • Combination of 5-alpha-reductase inhibitor and alpha₁-blocker

3. Surgical and other invasive treatments
   • Transurethral resection of the prostate (TURP)
   • Transurethral incision of the prostate (TUIP)
   • Open prostatectomy
   • Green laser treatment
   • Thermotherapy (microwave treatment)
   • Stent or spiral

4. Catheter
   • Percutaneous cystostomy or catheterization
   • Repeated catheterization
   • A silicon catheter with the balloon filled with hypertonic (5%) saline or glyserol

Follow-up Treatment after TURP

1. Urine bacterial culture
2. Antibiotics (if bacterial infection is detected)
3. Pelvic floor muscle exercises for stress incontinence
4. Antimuscarinic drugs for urge incontinence and nocturia

Major Outcomes Considered

• Effect of treatment on factors such as symptoms prostate volume peak urinary flow residual urine volume urinary flow rate risk of overall clinical progression
• Adverse effects of treatment

Methods Used to Collect/Select Evidence

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

The evidence reviewed was collected from the Cochrane database of systematic reviews and the database of abstracts of reviews of effectiveness (DARE). In addition the Cochrane Library and medical journals were searched specifically for original publications.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Classification of the Quality of Evidence

GRADE (Grading of Recommendations Assessment Development and Evaluation) Working Group 2007 (modified by the EBM Guidelines Editorial Team).

Methods Used to Analyze the Evidence

Systematic Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Peer Review

Description of Method of Guideline Validation

Not stated

Major Recommendations

The levels of evidence [A-D] supporting the recommendations are defined at the end of the "Major Recommendations" field.

Aims

• The diagnosis of benign prostatic hyperplasia is based on symptoms and basic investigations. Other causes of voiding disturbances (prostate cancer in particular) are excluded.
• Conditions requiring surgical management are recognized.
• Follow-up alone or drug therapy are good options in patients with relatively mild symptoms and no complications of urinary tract stricture.

Symptoms

• Storage symptoms
  • Extraordinary voiding frequency
  • Nocturia
  • Urinary urgency
  • Urge incontinence
• Voiding symptoms
  • Difficulty in the initiation of voiding
  • Poor urine flow
  • Need to strain while voiding
  • Discontinued voiding
  • Feeling of inadequate bladder emptying
  • Urinary retention

Primary Investigations

• Symptom questionnaire
  • A commonly used questionnaire is International Prostatic Symptom Score (IPSS) (See Questionnaire List in the original guideline document).
  • The questionnaire is useful in the assessment of severity of symptoms when decisions are made between follow-up drug treatment and surgery.
• Writing down details associated with voiding
• DRE (digital rectum examination)
• Urinalysis
• Serum/plasma creatinine
• Serum prostate-specific antigen (PSA)
• Residual urine volume is determined by ultrasonography (see the Finnish Medical Society Duodecim guideline "Determining the Volume of Residual Urine by Ultrasonography") (See Video 1 in the original guideline document) (or if ultrasonography is not available by catheterization). Ultrasonography is useful in the determination of prostatic size (calculated with the same equation as residual urine volume [see the Finnish Medical Society Duodecim guideline "Determining the Volume of Residual Urine by Ultrasonography"]) shape and eventual hydronephrosis.
• Differential diagnosis see table below.

Table: Differential Diagnosis on Benign Prostatic Hyperplasia

Indications for Specialist Consultation

Indications for Diagnostic Investigations by the Urologist

• The patient is below 50 years of age.
• DRE is suspicious (nodules or induration).
• Serum PSA is above 10 micrograms/L (above 3 micrograms/L in patients below 65 years of age).
  • If the serum total PSA concentration is in the range of 3 to 10 micrograms/L measuring free/total PSA ratio is recommended. If this value is under 0.15 the probability of prostatic cancer is increased (Walsh 1996) and a urologist should be consulted.
  • DRE before determination of serum PSA level does not influence the result.
• Rapidly developing symptoms
• Haematuria (cystoscopy)
• Diabetics who may have neuropathy
• History of pelvic surgery or irradiation
• Neurological disease or injury affecting the function of the urinary bladder
• Necessary medication affecting the function of the urinary bladder
• Lower abdominal pain as the main symptom
• Discrepancy between symptoms and findings
• The investigations performed by the urologist usually include:
  • Urine flow measurement
  • Transrectal ultrasonography
• And if necessary also
  • Cystometry and pressure-flow examination (recommended before deciding on surgery if the peak flow is >10 mL/s and also when there is a discrepancy between symptoms and findings or the patient has undergone surgery of the lower urinary tract)
  • Urethrocystography
  • Urography
  • Prostatic biopsies
  • Cystoscopy

Surgical Treatment Is Indicated in the Following Cases

• Urinary retention overflow incontinence or repeatedly more than 300 mL of residual urine
• Severe symptoms not relieved by drug therapy
• Severe narrowing based on measurement of flow rate
• Dilatation of the upper urinary tract
• Impairment of renal function
• Recurrent macroscopic haematuria
• Urinary tract infections
• Bladder calculi
• Severe or moderate symptoms in a patient who wants rapid relief or if satisfactory results have not been obtained with other treatments

Conservative Treatment

Follow-up

• As the symptoms of benign prostatic hyperplasia (BPH) vary greatly and the course of the disease in an individual cannot be fully predicted follow-up is a suitable approach in patients with mild symptoms. Also in moderate symptoms follow-up can be the initial approach if the symptoms do not essentially affect the quality of life and complications have not developed.
• Follow-up includes explaining to the patient the nature of the disease and carrying out basic investigations annually or when symptoms have changed. Opportunistic follow-up during other encounters in primary care is one method of screening.

Drug Treatment

• Although the effectiveness of drug treatment is not as good as that of surgery it is often sufficient for reducing or alleviating the symptoms.
• When deciding on the treatment cost-effectiveness should also be evaluated (i.e. when would invasive therapy which usually gives complete cure cost less and be more convenient for the patient than drug therapy continuing for years). Transurethral resection is more cost-effective than drug treatment.
• Patients on drug treatment should be followed up regularly at 6- to 12-month intervals to detect complications resulting from urethral obstruction.
• The size of the prostate and total serum PSA determine the selection of the therapy (Boyle Gould & Roehrborn 1996; Boyle et al. 2003) [A]. If the prostate is not markedly enlarged on palpation or in ultrasonography (<30 ml) and psa is <1.5 the first choice is an alpha₁-blocker (e.g. tamsulosin or alfuzosin) (Lepor et al. 1996; Boyle Gould & Roehrborn 1996). If the prostate is markedly enlarged or PSA is >1.5 micrograms/L either 5-alpha-reductase inhibitor (finasteride dutasteride) (Wilde & Goa 1999; Roehrborn et al. 2002; Debruyne et al. 2004) [A] or an alpha₁-blocker can be used.
• A combination of 5-alpha-reductase inhibitor and alpha₁-blocker alleviates symptoms more effectively than either drug alone (McConnell et al. 2003) [A].

Alpha-blockers

• Tamsulosin (Wilt MacDonald & Rutks 2002) [A] alfuzosin doxazosin terazosin and prazosin.
• Alpha₁-blockers (Webber 2005) [A] decrease symptoms increase peak urinary flow and reduce the volume of residual urine significantly more than placebo.
• The effect of alpha₁-blockers is seen rapidly and it has been shown to continue for several years.
• The patients should be followed up initially at 1- to 3-month intervals.
• The side effects include dizziness postural hypotension and missing of ejaculation which is more rare with alfuzosin than with tamsulosin. With selective tamsulosin and alfuzosin the risk of hypotension is lower.

5-Alpha-Reductase Inhibitors (5ARI)

• The dose of finasteride is 5 mg x 1 and that of dutasteride is 0.5 mg x 1.
• The symptoms are alleviated the urine flow is increased and the obstruction is decreased (Wilde & Goa 1999; Roehrborn et al. 2002; Debruyne et al. 2004) [A].
• The effect is at its best in patients with large prostates (Boyle Gould & Roehrborn 1996; Boyle Roehrborn & Marks 2003) [A] (Walsh 1996).
• The effect starts slowly sometimes as late as 6 months after the onset of treatment. If no effect is observed in 6 months the indications for surgery should be reconsidered.
• The drug decreases prostatic size but the prostate returns to its original size a few months after discontinuation of treatment.
• Impotence may occur as an adverse effect.
• Although treatment with 5-alpha-reductase inhibitors decreases serum PSA level by about 50% this makes follow-up no more difficult than with alpha-blockers: an increasing PSA concentration is an indication for investigation by a urologist.

Surgical and Other Invasive Treatments

• Transurethral resection of the prostate (TURP) (Webber 2005) [A]
  • The only treatment for complicated prostatic hyperplasia and the best documented treatment for uncomplicated disease
  • Results very seldom in erectile dysfunction (though in most cases already before operation) almost always retrograde ejaculationr
• Transurethral incision of the prostate (TUIP)
  • Suitable for patients with prostates <30 ml in volume and with no prominent median lobe protruding towards the li>
• Open prostatectomy
  • Rarely used nowadays (prostate >100 mL)
• Green laser treatment
  • An alternative to transurethral resection
  • Data on the outcomes in long-term follow-up are lacking.
• Thermotherapy (microwave treatment) (Hoffman et al. 2007) [A]
  • Alleviates irritative symptoms
  • Long-term results are not available
• Stent or spiral
  • Can be used in selected cases in patients with a poor general condition

Catheter

• Percutaneous cystostomy is indicated in patients with urinary retention waiting for surgery (good skills in the insertion technique required). In selected cases repeated catheterization can be used (preferably by the patient himself).
• A silicon catheter with the balloon filled with hypertonic (5%) saline or glyserol can be used but percutaneous cystostomy is preferred.

Treatment after TURP

• Urine bacterial culture should be taken routinely 4 to 6 weeks after the operation to detect bacteriuria and always if a urinary tract infection is suspected (pyuria and haematuria may occur as long as 3 months after the operation).
• If bacterial growth is detected antibiotics are indicated.
• Stress incontinence may be alleviated within 1 year: exercises of pelvic floor muscles may help (Hunter Glazener & Moore 2007) [D].
• Antimuscarinic drugs (oxybutynin tolterodine trospium chloride solifenacin or darifenacin) can be used for the treatment of urge incontinence and nocturia.

Related Resources

Refer to the original guideline document for related evidence including Cochrane reviews and other evidence summaries.

Definitions:

Classification of the Quality of Evidence

GRADE (Grading of Recommendations Assessment Development and Evaluation) Working Group 2007 (modified by the EBM Guidelines Editorial Team).

Clinical Algorithm(s)

None provided

References Supporting the Recommendations

• Boyle P Gould AL Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology 1996 Sep;48(3):398-405. PubMed



• Boyle P Roehrborn C Marks L ym et al. Early use of dutasteride arrests prostate growth improves clinical parameters and prevents complications in men with benign prostatic hyperplasia. J Urol Suppl 2003;169:477.



• Debruyne F Barkin J van Erps P Reis M Tammela TL Roehrborn C. Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur Urol 2004 Oct;46(4):488-94; discussion 495. PubMed



• Hoffman RM Monga M Elliot SP Macdonald R Wilt TJ. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev 2007;(4):CD004135. [52 references] PubMed



• Hunter KF Glazener CM Moore KN. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev 2007;(2):CD001843. [79 references] PubMed



• Lepor H Williford WO Barry MJ Brawer MK Dixon CM Gormley G Haakenson C Machi M Narayan P Padley RJ. The efficacy of terazosin finasteride or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. N Engl J Med 1996 Aug 22;335(8):533-9. PubMed



• McConnell JD Roehrborn CG Bautista OM Andriole GL Jr Dixon CM Kusek JW Lepor H McVary KT Nyberg LM Jr Clarke HS Crawford ED Diokno A Foley JP Foster HE Jacobs SC Kaplan SA Kreder KJ Lieber MM Lucia MS et al. The long-term effect of doxazosin finasteride and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 2003 Dec 18;349(25):2387-98. PubMed



• Roehrborn CG Boyle P Nickel JC Hoefner K Andriole G. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002 Sep;60(3):434-41. PubMed



• Walsh PC. Treatment of benign prostatic hyperplasia. N Engl J Med 1996 Aug 22;335(8):586-7. PubMed



• Webber R. Benign prostatic hyperplasia. What are the effects of medical treatments?. Clin Evid 2005;13:1095-100.



• Wilde MI Goa KL. Finasteride: an update of its use in the management of symptomatic benign prostatic hyperplasia. Drugs 1999 Apr;57(4):557-81. [12 references] PubMed



• Wilt TJ MacDonald R Rutks I. Tamsulosin for benign prostatic hyperplasia. Cochrane Database Syst Rev 2002;(4):CD002081.

Type of Evidence supporting the Recommendations

Concise summaries of scientific evidence attached to the individual guidelines are the unique feature of the Evidence-Based Medicine Guidelines. The evidence summaries allow the clinician to judge how well-founded the treatment recommendations are. The type of supporting evidence is identified and graded for select recommendations (see the "Major Recommendations" field).

Potential Benefits

Appropriate diagnostic evaluation and treatment of benign prostatic hyperplasia

Subgroups of Patients within Target Population Most Likely to Benefit

Finasteride is most effective in men with large prostates.

Potential Harms

• Side effects of alpha₁-blockers include dizziness postural hypotension and retrograde ejaculation.
• Finasteride may cause impotence.
• Transurethral resection of the prostate may cause urinary tract infection stress incontinence urge incontinence nocturia retrograde ejaculation and very seldom erectile dysfunction.

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Quick Reference Guides/Physician Guides
Resources

For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.

IOM Care Need

Getting Better
Living with Illness

IOM Domain

Effectiveness

Bibliographic Source(s)

• Finnish Medical Society Duodecim. Benign prostatic hyperplasia. In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki Finland: Wiley Interscience. John Wiley & Sons; 2008 Sep 27 [Various].

Adaptation

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

Source(s) of Funding

Finnish Medical Society Duodecim

Guideline Committee

Editorial Team of EBM Guidelines

Composition of Group that Authored the Guideline

Primary Author: Teuvo Tammela

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Finnish Medical Society Duodecim. Benign prostatic hyperplasia. In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki Finland: Wiley Interscience. John Wiley & Sons; 2007 Apr 16 [Various].

Guideline Availability

This guideline is included in "EBM Guidelines. Evidence-Based Medicine" available from Duodecim Medical Publications Ltd PO Box 713 00101 Helsinki Finland; e-mail: info@ebm-guidelines.com; Web site: www.ebm-guidelines.com.

Availability of Companion Documents

The following are available:

• Benign prostatic hyperplasia. Quick Guide.
• Residual urine volume (ultrasonography). Video 1.

Electronic copies available to subscribers from Finnish Medical Society Duodecim Web site.

Patient Resources

None available

NGC STATUS

This summary was completed by ECRI on August 28 2001. The information was verified by the guideline developer as of October 26 2001. This summary was updated by ECRI on December 9 2002 December 29 2003 July 15 2004 February 18 2005 and November 2 2005. This summary was updated by ECRI on November 30 2005 following the U.S. Food and Drug Administration (FDA) advisory on Flomax. This summary was updated by ECRI on December 26 2006 and again on November 12 2007. This summary was updated by ECRI Institute on January 6 2009.

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