Definitions of the strength of the recommendations (recommended, optional and not recommended; standard, guideline, option) are defined at the end of the "Major Recommendations" field.
Diagnostic Evaluation of Benign Prostatic Hyperplasia
Initial Evaluation
Recommended: In the initial evaluation of all patients presenting with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH):
- A medical history should be taken to identify other causes of voiding dysfunction or comorbidities that may complicate treatment.
- A physical examination, including both a digital rectal examination (DRE) and a focused neurologic examination, should be performed.
- A urinalysis should be performed by dipstick testing or microscopic examination of the sediment to screen for hematuria and urinary tract infection (UTI).
- Measurement of the serum prostate-specific antigen (PSA) should be offered to the following patients: 1) those with at least a 10-year life expectancy and for whom knowledge of the presence of prostate cancer would change management; or 2) those for whom the PSA measurement may change the management of their voiding symptoms.
Optional: Urine cytology may be considered in men with a predominance of irritative symptoms, especially with a history of smoking or other risk factors, to aid in the diagnosis of bladder carcinoma in situ and bladder cancer.
Not recommended: The routine measurement of serum creatinine levels is not indicated in the initial evaluation of men with LUTS secondary to BPH.
Symptom Assessment
Recommended: The American Urological Association (AUA) Symptom Index (identical to the seven symptom questions of the International Prostate Symptom Score [IPSS]) should be used as the symptom-scoring instrument in the initial assessment of each patient presenting with BPH.
Optional: Other validated assessment instruments addressing the frequency or severity of LUTS in men with BPH, bother due to symptoms, interference with daily activities, urinary continence, sexual functioning and health-related general or disease-specific quality of life may be administered.
Optional Diagnostic Tests
Optional: Following the initial evaluation of the patient, urinary flow-rate recording and measurement of postvoid residual urine (PVR) may be appropriate. These tests usually are not necessary prior to the institution of watchful waiting or medical therapy. However, they may be helpful in patients with a complex medical history (e.g., neurologic or other diseases known to affect bladder function or prior failure of BPH therapy) and in those desiring invasive therapy.
Initial Management and Discussion of Treatment Options With the Patient
Management of Patients With Mild Symptoms or Moderate to Severe Symptoms Without Bother
Standard: Patients with mild symptoms of BPH (AUA Symptom Score <7) and patients with moderate or severe symptoms (AUA Symptom Score >8) who are not bothered by their symptoms (i.e., they do not interfere with the daily activities of living) should be managed using a strategy of watchful waiting.
Management of Patients With Bothersome Moderate to Severe Symptoms
Option: Treatment options for patients with bothersome moderate to severe symptoms of BPH (AUA Symptom Score >8) include watchful waiting and the medical, minimally invasive, or surgical therapies defined in Table 1.1. of the guideline document.
Guideline: Information on the benefits and harms of the BPH treatment options (including watchful waiting) should be explained to patients with moderate to severe symptoms (AUA Symptom Score >8) who are bothered enough to consider therapy.
Optional Diagnostic Tests for Patients Who Choose Invasive Therapy
Optional: Additional diagnostic tests, such as pressure-flow urodynamic studies, urethrocystoscopy and ultrasound (transrectal or transabdominal), are optional in patients choosing invasive therapies, particularly when the outcome of the pressure-flow study may impact choice of intervention or if prostate size and anatomical configuration are important considerations for a given treatment modality. They are not recommended in the initial evaluation of LUTS or in a setting other than those described above.
Not Recommended: Filling cystometrography (CMG) and imaging of the upper urinary tract by ultrasonography or excretory urography are not recommended in the evaluation of the typical patient with symptoms of BPH unless the patient has hematuria, UTI, renal insufficiency, or a history of urolithiasis or urinary tract surgery.
Treatment Recommendations
Recommended Therapies
Watchful Waiting
Watchful waiting is the preferred management strategy for patients with mild symptoms. It is also an appropriate option for men with moderate to severe symptoms who have not yet developed complications of BPH (e.g., renal insufficiency, urinary retention or recurrent infection).
Watchful waiting is a management strategy in which the patient is monitored by his physician but receives no active intervention for BPH. The level of symptom distress that individual patients are able to tolerate is highly variable so that watchful waiting may be a patient's treatment of choice even if he has a high AUA Symptom Index or IPSS score. Watchful-waiting patients usually are reexamined yearly, repeating the initial evaluation.
As prostate volume assessed by DRE and/or serum PSA predicts the natural history of symptoms, flow rate, and risk for acute urinary retention and surgery, patients may be advised as to their individual risk depending on the outcomes of these assessments. Measures to reduce the risk, such as medical intervention, may be offered depending on the circumstances.
Medical Treatment
Alpha-adrenergic blocker therapy
Option: Alfuzosin, doxazosin, tamsulosin and terazosin are appropriate treatment options for patients with LUTS secondary to BPH. Although there are slight differences in the adverse-event profiles of these agents, the Panel believes that all four agents have equal clinical effectiveness.
Guideline: Data are insufficient to support a recommendation for the use of prazosin or the nonselective alpha blocker phenoxybenzamine as treatment options for LUTS secondary to BPH. (The recommendation concerning phenoxybenzamine is based on Panel expert opinion.)
Alpha-reductase inhibitor therapy
Option: The 5 alpha-reductase inhibitors finasteride and dutasteride are appropriate and effective treatments for patients with LUTS associated with demonstrable prostatic enlargement.
Option: Patients with symptomatic prostatic enlargement but without signs of bother may be offered a 5 alpha-reductase inhibitor to prevent progression of the disease. However, the disadvantages of this therapeutic approach (e.g., side effects such as sexual dysfunction) and the need for long-term daily therapy should be presented to the patient in comparison to a reasonable estimate of his baseline risk of progression (i.e., retention and the risks associated with BPH-related surgery) so that an informed decision can be made.
Guideline: 5 Alpha-reductase inhibitors are not appropriate treatments for men with LUTS who do not have evidence of prostatic enlargement.
Combination therapy
Option: The combination of an alpha-adrenergic receptor blocker and a 5 alpha-reductase inhibitor (combination therapy) is an appropriate and effective treatment for patients with LUTS associated with demonstrable prostatic enlargement. (This recommendation is based on Panel consensus.)
Minimally invasive therapies
Transurethral microwave heat treatment
Option: The following transurethral microwave heat treatments are effective in partially relieving symptoms in men with BPH: Prostatron®, Targis®, CoreTherm™, and TherMatrx™. There is no evidence from direct comparator trials to suggest superiority of one specific device over another.
Standard: Because unexpected procedure-related injuries have been associated with the use of transurethral microwave heat treatment devices, the safety recommendations published by the United States Food and Drug Administration (FDA) should be followed when using microwave heat treatment devices. (The following bolded text was taken directly from the FDA notice.)
- When considering a patient for microwave thermotherapy for BPH, ensure that he meets the device's indications, including the criteria for eligible prostate size indicated for the specific system being used. Additionally, it is important to verify that the patient has not had prior radiation therapy to the pelvic area, as these patients are at increased risk of rectal fistula formation. Furthermore, the labeling of each device lists specific patient populations for which safety and effectiveness of this therapy are unknown (e.g., those with prostate cancer).
- When discussing the procedure with the patient, it is important to ensure that he understands the risks and benefits listed in the labeling of the specific device. He also should understand the duration of the procedure, the level of pain or discomfort that should be considered normal, the importance of telling the physician of any unusual pain during treatment, how to operate any emergency stop button, and the need to remain as still as possible during treatment.
- Carefully follow the instructions for use provided with these microwave systems. Note that they require the physician to continually supervise the procedure throughout the entire treatment period. The physician must (1) verify that the retention balloons of the urethral catheter and rectal temperature sensor probe are free of leaks and (2) confirm the placement of the urethral catheter and rectal temperature sensor using acceptable methods (e.g., direct visualization, ultrasound imaging) both prior to treatment and at other specified times consistent with the manufacturer's recommendations. Either patient movement or component breakage may cause migration of a properly placed urethral catheter or rectal temperature sensor.
- Be careful not to oversedate the patient. As patient perception of pain is an important safety mechanism to ensure that the heating of the tissue is not excessive. General or spinal anesthesia should not be used.
- Closely monitor the patient and the equipment throughout the entire treatment, and manually pause treatment if the patient complains of excessive pain or anything unusual occurs.
While the Panel agrees in principle with the safety recommendations published by the FDA, it recognizes that these procedures can be safely performed under general or spinal anesthesia provided that all other safety measures are taken such as verifying position of the treatment catheter and retention balloon.
Transurethral needle ablation
Option: Transurethral needle ablation (TUNA) is effective treatment in partially relieving symptoms of BPH.
Stents
Guideline: Because prostatic stents are associated with significant complications, such as encrustation, infection and chronic pain, their placement should be considered only in high-risk patients, especially those with urinary retention.
Surgery
Guideline: The patient may appropriately select surgical treatment as his initial treatment if he has bothersome symptoms. Patients who have developed complications of BPH are best treated surgically.
Option: The choices of surgical approach (open or endoscopic and energy source--electrocautery versus laser) are technical decisions based on the patient's prostate size, the individual surgeon's judgment, and the patient's comorbidities.
Emerging therapies
Guideline: Phytotherapeutic agents and other dietary supplements cannot be recommended for treatment of BPH at this time. (This recommendation is based on both evidence and Panel expert opinion.)
Guideline: The Panel believes that additional data are required before the following therapies can be considered as recommended treatment options: interstitial laser coagulation, water-induced thermotherapy, and the PlasmaKinetic™ Tissue Management System. All of these interventions are categorized as emerging therapies even though several are FDA approved either for BPH or soft tissue ablation. It is not inappropriate for these options to be offered to the patient, but the uncertainty of outcomes compared to the recommended treatment options should be discussed with the patient.
Guideline: High-intensity focused ultrasound and absolute ethanol injection are investigational at this time and should not be offered outside the framework of clinical trials.
Balloon dilatation
Guideline: Balloon dilation is not recommended as a treatment option for patients with symptoms of BPH.
Therapies for patients with uncommon or serious complications of BPH
Guideline: Surgery is recommended for patients with refractory retention who have failed at least one attempt at catheter removal. In patients who are not surgical candidates, treatment with intermittent catheterization, an indwelling catheter or stent is recommended.
Option: Concomitant administration of an alpha blocker is an option prior to attempted catheter removal in patients with urinary retention. (This recommendation is based on Panel expert opinion.)
Guideline: Surgery is recommended for patients who have renal insufficiency clearly due to BPH and in those patients with recurrent UTIs, recurrent gross hematuria, or bladder stones clearly due to BPH and refractory to other therapies. The presence of a bladder diverticulum is not an absolute indication for surgery unless it is associated with recurrent UTI or progressive bladder dysfunction. (This recommendation is based on Panel expert opinion.)
Definitions:
Diagnostic Tests
Panel utilized the terms "recommended," "optional" and "not recommended" to indicate desirability of specific diagnostic interventions. A test was categorized as optional for the following reasons: 1) if there was clear evidence of its benefit for certain patients but the data were insufficient to demonstrate the test's value in confirming the diagnosis of BPH and in predicting the results of treatment for routine patients; or 2) if the definitions of normal and abnormal test values were uncertain. The evidence is thus insufficient to mandate use of the test prior to a decision to treat. If a test was not recommended, the Panel believed either that there was insufficient evidence to indicate clinical value or that in routine cases the test was associated with potential harms that exceeded its potential benefits.
Treatment Policies
With regard to treatment policies, the three levels of flexibility are defined as:
- Standard: A policy is considered a standard if the health and economic outcomes of the alternate interventions are sufficiently well known to permit meaningful decisions and if there is virtual unanimity about which intervention is preferred.
- Guideline: A policy is considered a guideline if the health and economic outcomes of the interventions are sufficiently well known to permit meaningful decisions and if an appreciable but not unanimous majority agrees upon the preferred intervention.
- Option: A policy is considered an option if the following criteria apply: a) the health and economic outcomes of the interventions are not sufficiently well known to permit meaningful decisions; b) preferences among the outcomes are not known; c) patients' preferences are divided among the alternative interventions; or d) patients are indifferent about the alternative interventions.
